# Men's Hair Loss > Hair Loss Treatments > Cutting Edge / Future Treatments >  Kythera Acquires Rights to PGD2 Blocking Setipriprant for New Hair Loss Treatment

## It's2014ComeOnAlready

Well this is exciting: 

http://globenewswire.com/news-releas...Hair-Loss.html

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## sdsurfin

setipiprant was shelved by the last company, and we didn't hear about any of their trial patients regrowing hair, even though that's not what they were testing it for.  Still kinda intriguing, but even if it does help, how long will this take to get to market? Haven't even had a phase I yet.  Also, can we get a hold of this stuff anywhere? Seems to have been safe for allergy sufferers to take in three trials, and should be easy enough to see if it works for hair.

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## It's2014ComeOnAlready

> setipiprant was shelved by the last company, and we didn't hear about any of their trial patients regrowing hair, even though that's not what they were testing it for.  Still kinda intriguing, but even if it does help, how long will this take to get to market?* Haven't even had a phase I yet*.  Also, can we get a hold of this stuff anywhere? Seems to have been safe for allergy sufferers to take in three trials, and should be easy enough to see if it works for hair.


 Uhh, setipiprant has gone through 8 clinical trials, including a phase 3 study. I'm assuming it would need one trial for hair loss. Read the article.

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## Tenma

"... Actelion will be eligible to receive up to *$27 million* in potential development and regulatory milestones, as well as royalties on sales if setipiprant is successfully commercialized.."

Wow, thats good money. Very interesting, thanks for posting

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## It's2014ComeOnAlready

Chief Medical Officer of Kythera: "These observations are potentially the most innovative new thinking in hair loss *over the last two decades* (Think Propecia). *Setipriprant is believed to directly affect this hair loss pathway, and our own preclinical and in vitro human hair models confirmed this effect*. It is a well-characterized molecule with a large safety database and we believe we can *quickly* initiate a development program to study it in hair loss. Putting these two pieces of the puzzle together is ideal and represents an example of our approach to scientifically sound and *efficient* drug development."

If this isn't great news, I don't know what is.

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## HairlossAt15

This is huge new.  Expect for articles and hopefully word from cotsarelis

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## sdsurfin

It all sounds good, the only thing that bothers me is that Actelion shelved the drug and never mentioned anything about hair.  I know that Graza ad Cots have been trying to find the right PGD2 drug for a while though, maybe this is a good candidate.

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## Jonathan

Setipiprant has been produced before and it has been tested to be safe. I assume that the ingredients are official... How can we get this stuff NOW?! 

Kane? Crowfunding?

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## Tenma

> It all sounds good, the only thing that bothers me is that Actelion shelved the drug and never mentioned anything about hair.  I know that Graza ad Cots have been trying to find the right PGD2 drug for a while though, maybe this is a good candidate.


 Because they werent rubbing the stuff onto their heads. They were after astma... now they will probably develop a topical and test different doses

Its interesting that actelion will continue developing the stuff on their own.

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## EXprettyboy

Cotsarellis' research found elevated pgd2 in bald scalps.

Pgd2 receptors can be blocked by a safe clinically trialled drug.

A company has just acquired a worldwide patent for this drug, after a period of curious silence from cotsarelis.

Somebody wanna get Kane on this, IMMEDIATELY!!

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## sdsurfin

Actually the press release states that it is meant for oral use.  Not positive that they wouldn't try to make it a topical too though.  But yeah for real somebody get kane on this immediately, it has to be easier to come by than CB.

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## sdsurfin

Frederick Beddingfield, MD, PhD

Specialty :Big Grin: ermatology
Department Affiliation:Medicine, Dermatology
Hospital Affiliation:Ronald Reagan UCLA Medical Center
Phone:310-825-6911

This guy is the head of research at Kythera.  Someone should give him a call or set up a dermatology appointment with him (if you're in cali) and ask him why they think setipriprant has potential for hair loss, and how they plan to use it, topically or orally.  Could be huge for forum people, if we can get this compound and figure out how to use it it might be a big help.  Curiously, he also has worked for Allergan, the company developing bimatoprost.  If I was in cali I'd definitely try to set up an appointment with him, he probably has a lot to say on hairloss.

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## sdsurfin

"All subjects completed the study. Both formulations were well tolerated, with headache the most frequently reported adverse event (25% of subjects), followed by flatulence (15%) and somnolence and fatigue (10%). The adverse event profile in men and women and between formulations was similar."

hmmmmmm   headaches? not so fun. I'll fart all day for a full head of hair though.  These are some pretty high side effect percentages, I hope they do make a topical version.

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## Jonathan

Can you please link to the source?

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## Sogeking

Good news. However I hope we won't have to wait for 10+ years for this to come out.

Things are finally heating up, a lot of treatments coming. It seems I was born too early...

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## sdsurfin

Just look up setipriprant clinical trials. 

Also, I'm not sure if any of this is worth getting excited about. there have been other compounds that do the same thing, such as  OC000459 , which have been trialled by forum users without too much success. They seemed to sort of work but then stop working after a while. I think the whole PGD2 issue is only a part of the puzzle.  Would definitely be good to talk to an expert about it.

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## beetee

Obviously going to take some time for this to follow its course and we don't know if it will be effective or not, but there's no doubt this goes in the good news category. I'll even put it in the very good news category.

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## burtandernie

Ill be perfectly honest that I would like to see some study or a little more evidence before getting my hopes too high, but this is the news of the year that no one saw coming. If this isnt crazy positive news I dont know what is. The fact this is based off the PGD2 discovery really lends this a ton of credibility and they said they already have solid evidence this actually works. News of the year IMO

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## It's2014ComeOnAlready

> Ill be perfectly honest that *I would like to see some study or a little more evidence before getting my hopes too high*, but this is the news of the year that no one saw coming. If this isnt crazy positive news I dont know what is. The fact this is based off the PGD2 discovery really lends this a ton of credibility and they said they already have solid evidence this actually works. News of the year IMO


 There's a quote I posted from the Chief Medical Officer of Kythera saying that the compound works in the human hair pathway in all of their own studies. Also, I'm sure Cotsarelis had been using a similar formula in their follicular neogenesis trials. A study was published saying that pgd2 inhbits follicle neogenesis, so in order to actually run their trials, they would need a compound to inhibit pgd2. It must work, because Follica had run 2 trials, and still, a huge biopharmaceutical company wants to produce it. 

I wouldn't underestimate this kind of news. It could be the kind of news a lot of people looking for a new treatment have been waiting on.

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## It's2014ComeOnAlready

Also would add that the tolerability of this medication is the same to both men and women.

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## It's2014ComeOnAlready

They even finished a tolerability study on healthy men and women in Sept. 2013. The name of the doctor running the study was Daniela Baldoni! HAHA cannot make this stuff up.

http://www.clinicaltherapeutics.com/...950-8/abstract

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## x4342

I liked this line:

"which together could enable KYTHERA to bring a new treatment to the *very large and still highly unsatisfied hair loss market.*"


Yep.

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## Jasari

Never heard of this. What's the consensus? Promising?

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## It's2014ComeOnAlready

> Never heard of this. What's the consensus? Promising?


 This basically says that all the work and rights to Cotsarelis' work with PGD2 belong to a company that is going to trial with an already existing a PGD2 antagonist for hair loss. It's all of the pgd2 stuff coming to fruition.

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## Gerhard

> Never heard of this. What's the consensus? Promising?


 Quite. I'm not getting myself too excited, but it is a good and perhaps a very good step in the right direction.

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## It's2014ComeOnAlready

> Quite. I'm not getting myself too excited, but it is a good and perhaps a very good step in the right direction.


 Kythera is presenting tomorrow at the 2015 Leerink Global Healthcare Conference with livestreaming. Hmm. Apparently the video we be kept up for the next 2 weeks. Interesting.

Here's a link to the conference tomorrow at 10am. Check in the investor section: http://www.kytherabiopharma.com/

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## It's2014ComeOnAlready

WOW, holy crap this in informative:

http://files.shareholder.com/downloa...0Deck%209FEB15[1].pdf

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## It's2014ComeOnAlready

Since this drug has done 8 clinical trials, a phase 3 safety, can anyone deny or confirm that all they need to do is a proof-of-concept?

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## Gerhard

> Kythera is presenting tomorrow at the 2015 Leerink Global Healthcare Conference with livestreaming. Hmm. Apparently the video we be kept up for the next 2 weeks. Interesting.
> 
> Here's a link to the conference tomorrow at 10am. Check in the investor section: http://www.kytherabiopharma.com/


 Thanks for updating this with some more info, 2014. It's greatly appreciated. Again, I'm not trying to get my hopes up but I'm reading over the pdf you posted. It's good to see a reputed biopharmaceutical company such as Kythera taking an interest in this. I hope to see more and more good news every day, guys.

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## Gerhard

> Since this drug has done 8 clinical trials, a phase 3 safety, can anyone deny or confirm that all they need to do is a proof-of-concept?


 That is just about what I was going to ask as well. If that's the case that's fantastic news.

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## It's2014ComeOnAlready

> That is just about what I was going to ask as well. If that's the case that's fantastic news.


 I mean that whole page is blank except for 1. open an IND 2. Initiate a proof of concept.

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## sdsurfin

> There's a quote I posted from the Chief Medical Officer of Kythera saying that the compound works in the human hair pathway in all of their own studies. Also, I'm sure Cotsarelis had been using a similar formula in their follicular neogenesis trials. A study was published saying that pgd2 inhbits follicle neogenesis, so in order to actually run their trials, they would need a compound to inhibit pgd2. It must work, because Follica had run 2 trials, and still, a huge biopharmaceutical company wants to produce it. 
> 
> I wouldn't underestimate this kind of news. It could be the kind of news a lot of people looking for a new treatment have been waiting on.


 
I'm still skeptical.  the same types of compounds (OC, which is highly potent in the same way, ramatroban) have been used by forum people with very little success. Also, the side effects of this, at least taken orally, don't sound fun.   Also, I would absolutely not assume that they won't run many trials because it has been safety tested for other uses.  Might shave a year off or so, but best believe they will still do efficacy and dosing studies, and who knows when they will start, so this is also nothing that's coming very soon.  I would love to be proven wrong, they should really ask the people at the company this stuff.  At least it's not bad news, but the fact that hair growth was not a standout effect in the asthma trials, and the side effect profile for this make me hold back on my enthusiasm.  Having a headache and being fatigued nonstop would maybe be worse than losing your dick power.

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## It's2014ComeOnAlready

> I'm still skeptical.  the same types of compounds (OC, which is highly potent in the same way, ramatroban) have been used by forum people with very little success. Also, the side effects of this, at least taken orally, don't sound fun.   Also, I would absolutely not assume that they won't run many trials because it has been safety tested for other uses.  Might shave a year off or so, but best believe they will still do efficacy and dosing studies, and who knows when they will start, so this is also nothing that's coming very soon.  I would love to be proven wrong, they should really ask the people at the company this stuff.  At least it's not bad news, but the fact that hair growth was not a standout effect in the asthma trials, and the side effect profile for this make me hold back on my enthusiasm.  Having a headache and being fatigued nonstop would maybe be worse than losing your dick power.


 Dude, all of what I'm saying is based on what's presented. All of what you're saying is negative speculation.

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## Gerhard

> Having a headache and being fatigued nonstop would maybe be worse than losing your dick power.


 What world do you live in, man? I'd gladly take a headache to retain my dick. I can quit and be free of a headache. With fina I could lose my dick. I don't know where you rank the importance of your manhood, but I personally put it in the top 3: dick, body, hair.

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## sdsurfin

Not true. I really want to be positive about this one.  I'm speculating based on the trials that people have run on very similar compounds since 2012. Look up "OC hair loss", you'll find lots of users who used a basically identical molecule with little effect.  Also the side effects I listed are based on the results of the trials on asthma. 25 percent of people got headaches.  And Gerhard, Not having a headache is crucial to my quality of life, as is not being tired all the time.  Sex is important but I would take never having sex over having a pounding brain all the time.  that sounds like a true nightmare.  Both would definitely totally suck.  But the brain comes at number one as far as what's important to me. Hair is not even in the top five as far as my manhood is concerned.  My brain, my wit, my relationships, my honor, my body and probably more things rank above hair.

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## hellouser

Molecular Weight is 402 dalton. Not the best but not too big to penetrate skin. Some dermarolling along with this would be pretty good!

http://www.keyorganics.net/bionet/se...19fn2o3-1.html

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## hellouser

> Not true. I really want to be positive about this one.  I'm speculating based on the trials that people have run on very similar compounds since 2012. Look up "OC hair loss", you'll find lots of users who used a basically identical molecule with little effect.  Also the side effects I listed are based on the results of the trials on asthma. 25 percent of people got headaches.  And Gerhard, Not having a headache is crucial to my quality of life, as is not being tired all the time.  Sex is important but I would take never having sex over having a pounding brain all the time.  that sounds like a true nightmare.  Both would definitely totally suck.  But the brain comes at number one as far as what's important to me. Hair is not even in the top five as far as my manhood is concerned.  My brain, my wit, my relationships, my honor, my body and probably more things rank above hair.


 AGAIN:

OC is NOT this new stuff. Stop spreading misinformation.

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## Gerhard

> Not true. I really want to be positive about this one.  I'm speculating based on the trials that people have run on very similar compounds since 2012. Look up "OC hair loss", you'll find lots of users who used a basically identical molecule with little effect.  Also the side effects I listed are based on the results of the trials on asthma. 25 percent of people got headaches.  And Gerhard, Not having a headache is crucial to my quality of life, as is not being tired all the time.  Sex is important but I would take never having sex over having a pounding brain all the time.  that sounds like a true nightmare.  Both would definitely totally suck.  But the brain comes at number one as far as what's important to me. Hair is not even in the top five as far as my manhood is concerned.  My brain, my wit, my relationships, my honor, my body and probably more things rank above hair.


 I'm not medically qualified enough to determine whether they're the same or similar compounds or not. For now, what's being presented sounds promising. If it doesn't pan out and is another bust I suppose I'll cope. I read those previously, however those side effects don't necessarily bother me all that much. Flatulence, headache, etc. are all relatively minor and probably easily fixable compared to the ED, gyno, etc. etc. of messing with your androgen levels. Perhaps it's because I'm a pretty sexually active 19 year old male, but the idea of no sex is honestly the thing that terrifies me of fina even while I'm taking it (thank the lord those morning woods are still coming). I like sex, it's extremely important to me. My body was more or less a culmination of my overall physical health and then my brain function as well (which fina supposedly can effect as well with brain fog and such). 

Hellouser - Thanks for the link. Also, random thanks on my behalf for your posts in the RU section and in the trials you've done on yourself for the hairloss cause. It's greatly appreciated. What size of dermaroller would you suggest for the scalp? I believe I have a 1.5 laying around somewhere that I used for acne way back when.

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## sdsurfin

No sex is terrible, and I have felt firsthand propecia's effect on the brain.

I do have to correct my previous post, because I've been reading about other PGD2 blockers, and people seem to have maintained their hair completely while on them (search cetrizine).  So as a maintenance technique I think this actually has a lot of promise. Not sure it will regrow anything, and I'm not sure if kerythea knows that either after reading their press release.  

The side effects do scare me, there are several posters on the cetrizine thread that talk about withdrawal effects (severe itching, massive headaches) after stopping oral use of cterizine after prolonged use.  I think I will probably hop on the cetrizine train though for now, I can't take propecia or minox and maybe if I can hold on to what I've got for a few years something better will come along. I'm skeptical of replicel but still cautiously hopeful that it might be a long term fix.

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## It's2014ComeOnAlready

> No sex is terrible, and I have felt firsthand propecia's effect on the brain.
> 
> I do have to correct my previous post, because I've been reading about other PGD2 blockers, and people seem to have maintained their hair completely while on them (search cetrizine).  So as a maintenance technique I think this actually has a lot of promise. Not sure it will regrow anything, and I'm not sure if kerythea knows that either after reading their press release.  
> 
> The side effects do scare me, there are several posters on the cetrizine thread that talk about withdrawal effects (severe itching, massive headaches) after stopping oral use of cterizine after prolonged use.  I think I will probably hop on the cetrizine train though for now, I can't take propecia or minox and maybe if I can hold on to what I've got for a few years something better will come along. I'm skeptical of replicel but still cautiously hopeful that it might be a long term fix.


 Everything about this news seems to have gone completely over your head. This is all of Follica and Cotsarelis' work with pgd2 about to go into a trial. Could be just one trial because 3 safety trials were already completed in both men and women (and 8 trials total), the only thing they haven't done is test their topical formulation. You are off jabbering about nothing.

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## Gerhard

> Everything about this news seems to have gone completely over your head. This is all of Follica and Cotsarelis' work with pgd2 about to go into a trial. Could be just one trial because 3 safety trials were already completed in both men and women (and 8 trials total), the only thing they haven't done is test their topical formulation. You are off jabbering about nothing.


 Perhaps I read it wrong, but I thought they were going to go with an oral formula. Was I incorrect in that?

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## It's2014ComeOnAlready

> Perhaps I read it wrong, but I thought they were going to go with an oral formula. Was I incorrect in that?


 I don't believe it listed the delivery or the type of vehicle. I just assumed it was topical because Cots said all along it would be topical. Plus oral doses have already gone through trials with healthy adult men and women.

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## sdsurfin

> Everything about this news seems to have gone completely over your head. This is all of Follica and Cotsarelis' work with pgd2 about to go into a trial. Could be just one trial because 3 safety trials were already completed in both men and women (and 8 trials total), the only thing they haven't done is test their topical formulation. You are off jabbering about nothing.


 
Do you read anything? The press release from Kythera states very clearly that they will test this as an oral formulation. Nothing about topicals.  Also, they very clearly posted their side effects in their clinical studies. I am not saying this is useless.  Other PGD2 blockers have already proven to completely halt hair loss.  However, even the scientists do not have the testing knowledge that online users do.  This is a different compound, which is good, but it is very similar, and probably has similar side effects.  Prolonged users of cetrizine report very bad withdrawals with itching and headaches when they go off the drug.  I'm guessing the same will happen with this one after prolonged oral usage, though I can't be certain obviously.  I'm still encouraged that new info on hair loss is being put to use, and I plan to go on topical cetrizine immediately.  

Also there is no reason to think that clinical trials will not be done as a separate thing for hair loss.  Im sure they will test the efficacy and dosage in prolonged trips before they spend the money to market this for AA.

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## sdsurfin

Read the press release. It's oral.

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## It's2014ComeOnAlready

> Read the press release. It's oral.


 I read it. I'm pretty sure you're not getting the context. It's saying that Setipiprant is in it's current form, a selective oral antagonist of pgd2. We know that. The press release does not mention in which form it will be delivered. Do you get the difference? 

 Cotsarelis' numerous suggestions that it would be delivered topically is still a possibility, because we don't know yet how it will be applied.

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## DanWS

> Cotsarelis' numerous suggestions that it would be delivered topically is still a possibility, because we don't know yet how it will be applied.


 On the technology platform Follica are reported to be using...




> Like most baldness procedures it sounds mildly terrifying: they start with a process called 'skin-peturbation' where the top layers of the scalp are peeled back. The cells beneath then revert to a stem-cell like state, and a* topical solution is applied* to the area that re-boots the cells to start producing hair.


 http://www.huffingtonpost.co.uk/2013...n_3892684.html

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## sdsurfin

> I read it. I'm pretty sure you're not getting the context. It's saying that Setipiprant is in it's current form, a selective oral antagonist of pgd2. We know that. The press release does not mention in which form it will be delivered. Do you get the difference? 
> 
>  Cotsarelis' numerous suggestions that it would be delivered topically is still a possibility, because we don't know yet how it will be applied.


 I meant the investors release. not the press release. The press release doesn't say anything but the other one does. It specifically says it its oral.  Also, DanWS this has nothing to do with follica other than the fact that cotsarellis is involved with both things.  This will not involve wounding or topicals or any of that.  These guys are working on different things at once.  Actually the fact that they have sold off the rights to the PGD2 research only makes it clearer that the whole wounding thing has probably been abandoned.  Cotsarellis' research on PGD2 action is what has been purchased by kythera, not follica or that line of inquiry.

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## sdsurfin

http://files.shareholder.com/downloa...0Deck%209FEB15[1].pdf


that's the link. look it up yourself.

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## sdsurfin

This is a comment from two years ago on another forum  :Smile:   just goes to show how crowdsourced info is always ahead of the curve these days.  I'm pretty positive this drug is going to have some efficacy, especially and maintaining hair, but also pretty sure the side effects are not gonna be fun.  This is not baseless speculation, look online for what people say about cetrizine or other similar compounds.  Drowsiness and headaches are big time, and both came up in the clinical trials for this drug too.  Still, might be worth taking until someone comes out with a cell based treatment.  



"TaKeeLa

23.03.2012, 12:14 

@ TaKeeLa	
PGD2 RECEPTOR 2 ANTAGONIST (BLOCKER)
» These aren't the same receptors? You are saying DP2 and CRTH2 not PGD2??

I think this is what you are looking for....

Setipiprant by Actelion blocks the right PGD2 receptor implicated in MPB (PD2). Right now, setipiprant is in phase 2/3 testing. "

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## HairlossAt15

Most important part:




Hairs grows as normal when PGD2 blocked, this is human hair!

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## walrus

> I'm skeptical of replicel but still cautiously hopeful that it might be a long term fix.


 Even if things like replicel work, you will still probably need something like this to normalise prostaglandin levels in the scalp and avoid going back to square one.

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## Jonathan

According to to shareholders info:
During 2015/16
- Open an IND for sepiprant
- *Initiate* a Proof-of-Concept study for sepiprant	

...It will take time before it hits the stores so lets find a way to get hold of sepiprant and make our own proof-of-concept instead of whining about how long everything takes and that no one cares. Now we actually have a chance to do something ourselves. The product has been tested to be safe, so what are we waiting for? It could be as simple as this:
 We find one dedicated member that can organize this (PM)
 Every one in here helps to vacuum the internet to find the best source that can provide sepiprant.
 When the source is validated by the most knowledgeable members in here, maybe we even can lab test the drug to make sure its legit.
 PM is collecting money and info regarding age,sex,current regimes etc from users who want to participate in this study and buys a big stock of sepiprant.
 PM is distributing sepiprant to the participants and collects weekly photos from them and publish them on a web page  in an organized way (participants only get the drug if he/she provides photos). If we get many participants we could even try different strengths etc without telling the participant (but no placebo for sure)
...then *6 months from now we know if its working or not!*. I would not mind taking the PM role if i am trusted, but I live in Sweden and that is maybe not optimal place distribution wise. I think its important that all participants use same source and that we have one guy in the middle that organizes it, so not everyone is doing it their own way and it end up as usual with 100 diverting result that you don't know what to trust.

Let me know if any one else thinks this is a good idea.

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## Hairismylife

> According to to shareholders info:
> During 2015/16
> - Open an IND for sepiprant
> - *Initiate* a Proof-of-Concept study for sepiprant	
> 
> ...It will take time before it hits the stores so lets find a way to get hold of sepiprant and make our own proof-of-concept instead of whining about how long everything takes and that no one cares. Now we actually have a chance to do something ourselves. The product has been tested to be safe, so what are we waiting for? It could be as simple as this:
>  We find one dedicated member that can organize this (PM)
>  Every one in here helps to vacuum the internet to find the best source that can provide sepiprant.
>  When the source is validated by the most knowledgeable members in here, maybe we even can lab test the drug to make sure its legit.
> ...


 Count me in.  But what means by IND?

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## Jonathan

> Count me in.  But what means by IND?


 http://www.fda.gov/drugs/development...on/default.htm

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## sosa56

Is anyone able to listen to this http://leerink.metameetings.com/conf...hp?ticker=KYTH

Might contain useful info

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## It's2014ComeOnAlready

I'm pretty sure they would need to do one trial only. They have trialled this drug 8 times, have gotten through the fda hurdles. I'm assuming they're going to prepare a new formulation that needs to be tested, and given the extensive and well known safety profile, only need to know if it works. 

I'm sure they already know it works. Otherwise you wouldn't have this company buying the rights to produce it and run one trial. The company isn't even a huge pharmaceutical like merck or gsk or actavis.

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## It's2014ComeOnAlready

> Count me in.  But what means by IND?


 It allows the company to transport the investigational drug across state lines for means of research. Since this is already a heavily investigated drug with 8 clinical trials, 7 pubished papers etc they probably won't have any trouble getting it.

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## beetee

The chief medical officer of Kythera that's quoted in the press release used to be the chief medical officer of Allergan and was the go-to guy to explain bimatiprost for hair during their conference calls. Might not mean much (or anything) but if we could download the contents of his brain on here we'd probably know some interesting things about the potential for both of these treatments.

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## beetee

C

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## It's2014ComeOnAlready

> The chief medical officer of Kythera that's quoted in the press release used to be the chief medical officer of Allergan and was the go-to guy to explain bimatiprost for hair during their conference calls. Might not mean much (or anything) but if we could download the contents of his brain on here we'd probably know some interesting things about the potential for both of these treatments.


 You guys have literally been missing all the signs. Both work on prostaglandins, one stops hair loss, the other will regrow. It is the holy grail of treatments. Bimatoprost finished up its phase 2b study back in Nov when Allergan was sold for $13 billion more than any company was willing to offer. They planned on releasing their info for their phase 2b study in January, are now saying you'll have to wait for those results until 2016. Also, setipiprant has an excellent safety profile with over 1,000 men and women being tested. Not to mention that it has passed 8 trials. It would only need to do a proof-of-concept to test the efficacy of the application. Even the optimal dose has already been determined.

All those years of research by Cotsarelis and Follica, are now being funneled into one proof-of-concept trial. Then we have new treatments. Holy crap.

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## sosa56

So did and anyone listen to the company conference call I linked?

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## It's2014ComeOnAlready

> So did and anyone listen to the company conference call I linked?


 You can't listen unless you login with a company. I think it will be posted afterward, after it's edited. Then we can listen

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## Justinian

> You guys have literally been missing all the signs. Both work on prostaglandins, one stops hair loss, the other will regrow. It is the holy grail of treatments. Bimatoprost finished up its phase 2b study back in Nov when Allergan was sold for $13 billion more than any company was willing to offer. They planned on releasing their info for their phase 2b study in January, are now saying you'll have to wait for those results until 2016. Also, setipiprant has an excellent safety profile with over 1,000 men and women being tested. Not to mention that it has passed 8 trials. It would only need to do a proof-of-concept to test the efficacy of the application. Even the optimal dose has already been determined.
> 
> All those years of research by Cotsarelis and Follica, are now being funneled into one proof-of-concept trial. Then we have new treatments. Holy crap.


 As far as I know, the proof of concept trial will be phase 2 essentially. They could test different dosages here. They would then have to do a phase 3 to prove efficacy. It's dumb yes, but to my knowledge that's how it will work. Since they already did a phase 3 it would make sense for them to be able to market it after a phase 2, with a buyer knowing that it has only been safe not effective.

Also, this probably won't be a miracle cure in oral formulation since plenty of balding men had to have taken it in previous trials. It could definitely be a better finasteride that works more downstream, and in combination could contribute to a very effective regrowth solution.

----------


## It's2014ComeOnAlready

> As far as I know, the proof of concept trial will be phase 2 essentially. They could test different dosages here. They would then have to do a phase 3 to prove efficacy. It's dumb yes, but to my knowledge that's how it will work. Since they already did a phase 3 it would make sense for them to be able to market it after a phase 2, with a buyer knowing that it has only been safe not effective.
> 
> Also, this probably won't be a miracle cure in oral formulation since plenty of balding men had to have taken it in previous trials. It could definitely be a better finasteride that works more downstream, and in combination could contribute to a very effective regrowth solution.


 If you look at their presentation, it shows that they've already determined the optimal dose. Also, they've proved it's effective and it works in vitro. Cots is the foremost expert on hair research and he just partnered with a company to produce a treatment with a drug that's FDA approved.

----------


## hellouser

> You can't listen unless you login with a company. I think it will be posted afterward, after it's edited. Then we can listen


 Audio recording can be found here:

https://clyp.it/41mcx0mb

----------


## Justinian

Oh I must have missed the part about the dose.

I still think they will have to do a phase 3 for alopecia, though.

----------


## sosa56

> If you look at their presentation, it shows that they've already determined the optimal dose. Also, they've proved it's effective and it works in vitro. Cots is the foremost expert on hair research and he just partnered with a company to produce a treatment with a drug that's FDA approved.


 Yes I think 2014 is on the right track, this is basically cots statement way back when about how pgd2 inhibitors already approved could help in aga coming to life, this biotech company have been working with cots labs for the past two years it seems, this is pretty significant news, I just hope that they can do the proof concept v quickly and get the phase 3 out of the way in a year. I also hope that the treatment can regrow rather than just being a preventative

----------


## hellouser

> Yes I think 2014 is on the right track, this is basically cots statement way back when about how pgd2 inhibitors already approved could help in aga coming to life, this biotech company have been working with cots labs for the past two years it seems, this is pretty significant news, I just hope that they can do the proof concept v quickly and get the phase 3 out of the way in a year. I also hope that the treatment can regrow rather than just being a preventative


 If it cant regrow, i dont see it as much of an improvement over finasteride.

----------


## It's2014ComeOnAlready

> Oh I must have missed the part about the dose.
> 
> I still think they will have to do a phase 3 for alopecia, though.


 This drug has been trialled many, many times. Including a safety and tolerability trial with healthy men and women, that concluded Sept. 2013. Who's to say that they can't do one very large proof-of-concept trial? All that is needed to be known now is if their method of delivering the drug works. 

This is "first time hypothesis-driven approach taken to discovery of a hair growth treatment." That means after all those years of research, a company is taking the opportunity to test an already approved drug that follica had been using in their 2 follicle neogenesis trials. They know it works, and they want it to get it to market as soon as possible to be prescribed with bimatoprost.

----------


## It's2014ComeOnAlready

> Yes I think 2014 is on the right track, this is basically cots statement way back when about how pgd2 inhibitors already approved could help in aga coming to life, this biotech company have been working with cots labs for the past two years it seems, this is pretty significant news, I just hope that they can do the proof concept v quickly and get the phase 3 out of the way in a year. I also hope that the treatment can regrow rather than just being a preventative


 Bimatoprost will be used to regrow. The chief medical officer at Kythera, also used to be the chief medical officer at Allergan. Go figure.

----------


## Justinian

> This drug has been trialled many, many times. Including a safety and tolerability trial with healthy men and women, that concluded Sept. 2013. Who's to say that they can't do one very large proof-of-concept trial? All that is needed to be known now is if their method of delivering the drug works. 
> 
> This is "first time hypothesis-driven approach taken to discovery of a hair growth treatment." That means after all those years of research, a company is taking the opportunity to test an already approved drug that follica had been using in their 2 follicle neogenesis trials. They know it works, and they want it to get it to market as soon as possible to be prescribed with bimatoprost.


 I'm pretty sure the FDA does separate classifications for each use. The previous trials were not for alopecia, so they need a proof of concept for alopecia and then a phase 3 proving efficacy as far as I know. the previous trials only allow them to skip phase 1 and add additional safety data. It's dumb, but I'm pretty sure that's the way it is.

----------


## Sogeking

Proof of concept in drug development is usually Phase 1 or Phase IIa, so how do you guys know they are going to start with phase 2 or phase 3 trials? It was proven that CB-01-03 was safe, albeit in lesser percentage, with acne and yet they still had to do Phase 1, and Phase 2 trials.

----------


## It's2014ComeOnAlready

> I'm pretty sure the FDA does separate classifications for each use. The previous trials were not for alopecia, so they need a proof of concept for alopecia and then a phase 3 proving efficacy as far as I know. the previous trials only allow them to skip phase 1 and add additional safety data. It's dumb, but I'm pretty sure that's the way it is.


 Yes, but do you see how it makes no sense to do 2 trials? One would be to determine the efficacy and safety in a smaller group, and the last would be to test the efficacy in a large group. If you've already tested the safety in over 1000 men and women and found no problems, you would just have to be testing the efficacy of your product. I'm fairly certain they already know this works, otherwise they wouldn't be trialling a hair loss medication based on a hypothesis, if the hypothesis wasn't already correct. 

I'm not certain, and you're not certain. But I think my interpretation makes more sense, given how studied this drug is, on top of already testing the safety and tolerability on healthy men and women.

----------


## It's2014ComeOnAlready

> Proof of concept in drug development is usually Phase 1 or Phase IIa, so how do you guys know they are going to start with phase 2 or phase 3 trials? It was proven that CB-01-03 was safe, albeit in lesser percentage, with acne and yet they still had to do Phase 1, and Phase 2 trials.


 They are re-purposing a drug, not developing a new one.

----------


## It's2014ComeOnAlready

> If it cant regrow, i dont see it as much of an improvement over finasteride.


 Cots was quoted as saying it would be more effective than finasteride. Plus, the plan is to release it alongside bimatoprost for regrowth.

----------


## Parsia

> As far as I know, the proof of concept trial will be phase 2 essentially. They could test different dosages here. They would then have to do a phase 3 to prove efficacy. It's dumb yes, but to my knowledge that's how it will work. Since they already did a phase 3 it would make sense for them to be able to market it after a phase 2, with a buyer knowing that it has only been safe not effective.
> 
> Also, this probably won't be a miracle cure in oral formulation since plenty of balding men had to have taken it in previous trials. It could definitely be a better finasteride that works more downstream, and in combination could contribute to a very effective regrowth solution.


 Thanks for the info , So my question is why we don't hear anything about that until phase 3? I just got surprised because we always track new treatment and know about the company and also their trail phase and even wait for the next phase and most likely they fail or file the bank ruptcy, But for this one it came to news after phase 3 ! so whats going on actually?

----------


## Justinian

> Yes, but do you see how it makes no sense to do 2 trials? One would be to determine the efficacy and safety in a smaller group, and the last would be to test the efficacy in a large group. If you've already tested the safety in over 1000 men and women and found no problems, you would just have to be testing the efficacy of your product. I'm fairly certain they already know this works, otherwise they wouldn't be trialling a hair loss medication based on a hypothesis, if the hypothesis wasn't already correct. 
> 
> I'm not certain, and you're not certain. But I think my interpretation makes more sense, given how studied this drug is, on top of already testing the safety and tolerability on healthy men and women.


 
Unfortunately, just because your interpretation makes sense it doesn't mean that's how the FDA does it. If they have the dose figured out, I would think maybe they could go straight to phase 3, but they specified proof of concept trial which would not be phase 3.

----------


## Trouse5858

Realistically if things go well, how long to get this to market? 3 years?

----------


## hellouser

> Realistically if things go well, how long to get this to market? 3 years?


 They're sayng they can jump into Phase 2a right away... so:

1 year before they start trials (dont expect anything to start this year, theyre all slow)
1 year for phase 2a
1 year for phase 2b
1 year for phase 3
Time between phases for obligatory slacking
Time after phase 3 for FDA's ridiculous final green light.

SIGH.

----------


## Parsia

> Realistically if things go well, how long to get this to market? 3 years?


 I also have the same question ? anyone ? but please be realistic about your answer ! I don't want to put my expectation too high.

----------


## It's2014ComeOnAlready

> Unfortunately, just because your interpretation makes sense it doesn't mean that's how the FDA does it. If they have the dose figured out, I would think maybe they could go straight to phase 3, but they specified proof of concept trial which would not be phase 3.


 You are assuming you know what the FDA rule is. I am interpreting how they could do it, given that this drug has been trialled 8 times. Finasteride took a year to come out for hair loss after it had been approved for BPH. They had to lower the dose and run a trial. In this case, they know the optimal dose, they just need test that their formulation works for hair loss. Which, they already have in vitro, and in Follica's hair regeneration trials. 

You guys just don't want to accept great news. That's it.

----------


## RGPHILPA

In the link to the audio interview posted the speaker specifically states that they can begin at a phase IIa.   They'll definitely need to know the efficacy in a broader, more diverse patient population so will most likely require further trials than the POC.  But....since they know it's safe, maybe they can run the efficacy concurrently while commercializing?  I don't know.  I think this one is close, within the 5 year window. 

What i found interesting was that the speaker mentioned that they have good intellectual property protection, not only for the compound, but for "the method of use".  He describes the method as a novel insight that came out of the labs of Upenn.  I'm guessing this would be a reference to the wounding protocol that was patented with Cotsarelis's name on it.   That would succinctly explain why Follica went silent two years ago and laid off all their staff when this agreement was made.  Does anyone know otherwise? 

I also liked to hear that these trials will be cheap for them.  Cheap means fast.  No begging for funds necessary.

This is definitely the best news that i've heard hear in a long time.

----------


## Justinian

> You are assuming you know what the FDA rule is. I am interpreting how they could do it, given that this drug has been trialled 8 times. Finasteride took a year to come out for hair loss after it had been approved for BPH. They had to lower the dose and run a trial. In this case, they know the optimal dose, they just need test that their formulation works for hair loss. Which, they already have in vitro, and in Follica's hair regeneration trials. 
> 
> You guys just don't want to accept great news. That's it.


 I think this is really good news, I'm just trying to be realistic with how the FDA works.

----------


## Jonathan

Can someone explain what I am missing?
- We know that setipiprant is safe
- The recognized Dr George Cotsarelis says it work and is better than Finansteride
- A big biopharmaceutical company believes in it and have put a lot of money in it
- They will start to sell it as soon as the paperwork/proof is done
- We can buy it today, eg here: http://www.keyorganics.net/bionet/se...19fn2o3-1.html

Why are we not all ordering this already? What are we missing. The dosage? Do we need other ingredients than Setiprant?

----------


## finco

*Yeah do we know what the optimal dosage actually is?* If so could someone link me to this info.

Also the presentation said that there have been around 8 trials done on the drug, not of these study results are available as far as I know. And not mention of significant regrowth of hair has been noted in these trials, or not been reported.

----------


## It's2014ComeOnAlready

> *Yeah do we know what the optimal dosage actually is?* If so could someone link me to this info.
> 
> Also the presentation said that there have been around 8 trials done on the drug, not of these study results are available as far as I know. And not mention of significant regrowth of hair has been noted in these trials, or not been reported.


 Page 7 http://files.shareholder.com/downloa...0Deck%209FEB15

----------


## finco

> Page 7 http://files.shareholder.com/downloa...0Deck%209FEB15


 Thanks but that's in vitro.

----------


## It's2014ComeOnAlready

> Thanks but that's in vitro.


  Can you tell me why that makes a difference? You don't know how this will even be delivered as a drug. If they can determine the proper molar concentration per hair follicle, they can probably determine the dose.

----------


## sdsurfin

> Can someone explain what I am missing?
> - We know that setipiprant is safe
> - The recognized Dr George Cotsarelis says it work and is better than Finansteride
> - A big biopharmaceutical company believes in it and have put a lot of money in it
> - They will start to sell it as soon as the paperwork/proof is done
> - We can buy it today, eg here: http://www.keyorganics.net/bionet/se...19fn2o3-1.html
> 
> Why are we not all ordering this already? What are we missing. The dosage? Do we need other ingredients than Setiprant?


 
Well for starters it's 65 Bucks for 1 mg. Zyrtec has 10mg of pgd2 blocker per tablet. Maybe look into china to get it cheaper. I think the evidence that pgd2 pathways can stop hair loss is pretty damn conclusive. I'll be getting on centrifuge or ramatroban asap until this comes out in three years or so. My guess is they do a phase 2 and then a phase 3 and if it works it'll prob get released at the same time as bim. I'm hopeful about results the question is will the side effects be worth it. Bim has shown gnarly eye swelling even when not put in the eye, and these allergy mess cause serious withdrawal after a while and also make people drowsy and give headaches, and far more peeps get sides than with propecia. We should all be bugging kythera to consider this as a topical. If anyone has contact info for them pass it along. Or if you're in Cali plan a visit with their head of research, he's a dermatologist. Would be great to put a bug in his ear about reducing sides via topical application. And also ask him about bim eye swelling.

----------


## Illusion

Regarding the link > page 7: P=0.001 means it's a concentration of 0.001%? (I'm sorry I'm absolutely not familiar with this lol)

----------


## It's2014ComeOnAlready

> Regarding the link > page 7: P=0.001 means it's a concentration of 0.001%? (I'm sorry I'm absolutely not familiar with this lol)


 It's the statistical significance. It would mean that their conclusion is with less than 1% chance that it is wrong.

----------


## bigentries

People need to be realistic with timeline projections.

Dutasteride is considered safe, effective and it's widely prescribed off-label as a hair loss treatment, yet, it's still on it's way to be officially marketed as a hair loss treatment, keep in mind phase II ended in 2010 

This is a new drug, and from clinical studies, its efficacy has never been proved in vivo. Remember that, even Aderans and Intercytex had good results in proof of concept and in vitro studies. They need to demonstrate it does something first.

The only thing that keeps me optimistic is Cotsareli's involvement

----------


## finco

> People need to be realistic with timeline projections.
> 
> Dutasteride is considered safe, effective and it's widely prescribed off-label as a hair loss treatment, yet, it's still on it's way to be officially marketed as a hair loss treatment, keep in mind phase II ended in 2010 
> 
> This is a new drug, and from clinical studies, its efficacy has never been proved in vivo. Remember that, even Aderans and Intercytex had good results in proof of concept and in vitro studies. They need to demonstrate it does something first.
> 
> The only thing that keeps me optimistic is Cotsareli's involvement


 You make a very good point. Wait on the POC trials in 2015/2016 and take it from there.

----------


## walrus

> Dutasteride is considered safe, effective and it's widely prescribed off-label as a hair loss treatment, yet, it's still on it's way to be officially marketed as a hair loss treatment, keep in mind phase II ended in 2010


 Dutasteride comes with similar disadvantages as finasteride. There is little to distinguish it to warrant pushing for a rapid release.  

The PGD2 pathway will potentially avoid sexual side effects and the mechanisms have been demonstrated on ex-planted human follicles.

----------


## It's2014ComeOnAlready

> People need to be realistic with timeline projections.
> 
> Dutasteride is considered safe, effective and it's widely prescribed off-label as a hair loss treatment, yet, it's still on it's way to be officially marketed as a hair loss treatment, keep in mind phase II ended in 2010 
> 
> This is a new drug, and from clinical studies, its efficacy has never been proved in vivo. Remember that, even Aderans and Intercytex had good results in proof of concept and in vitro studies. They need to demonstrate it does something first.
> 
> The only thing that keeps me optimistic is Cotsareli's involvement


 This is NOT a new drug. It's been tested in 8 clinical trials, including a phase 3. If you want to mention Cotsarelis, this is HIS work. He sold global rights to a company so that they can run a trial, market, and distribute it.

----------


## beetee

> You guys have literally been missing all the signs. Both work on prostaglandins, one stops hair loss, the other will regrow. It is the holy grail of treatments. Bimatoprost finished up its phase 2b study back in Nov when Allergan was sold for $13 billion more than any company was willing to offer. They planned on releasing their info for their phase 2b study in January, are now saying you'll have to wait for those results until 2016. Also, setipiprant has an excellent safety profile with over 1,000 men and women being tested. Not to mention that it has passed 8 trials. It would only need to do a proof-of-concept to test the efficacy of the application. Even the optimal dose has already been determined.
> 
> All those years of research by Cotsarelis and Follica, are now being funneled into one proof-of-concept trial. Then we have new treatments. Holy crap.


 I'm not missing the point. Why do you think I posted the information? However, we still don't know what if anything either will do, which is why no one else is acting like it's a done deal. But I think most agree this is a good thing and we are happier for the time being.

----------


## bigentries

> This is NOT a new drug. It's been tested in 8 clinical trials, including a phase 3. If you want to mention Cotsarelis, this is HIS work. He sold global rights to a company so that they can run a trial, market, and distribute it.


 It is a new drug, it has never been commercialised

Dutasteride has been commercialised, has been involved in several clinical trials, and it's widely prescribed off-label as a hair loss treatment because the medical community considers it safe and effective.

And still, it's not officially approved for hair loss, and it's been years since the approval process started. Why is this drug any different?

Cotsareli's involvement is not a guarantee of success. He also had some success with wounding and lithium almost a decade ago and that lead nowhere, any attempt from forum members to replicate those results failed

----------


## hellouser

> Cotsareli's involvement is not a guarantee of success. He also had some success with wounding and lithium almost a decade ago and that lead nowhere, any attempt from forum members to replicate those results failed


 This is a lie.

His successes with wounding and lithium did not 'lead nowhere' as the clinical trials with Follica are still ongoing.

----------


## It's2014ComeOnAlready

> It is a new drug, it has never been commercialised
> 
> Dutasteride has been commercialised, has been involved in several clinical trials, and it's widely prescribed off-label as a hair loss treatment because the medical community considers it safe and effective.
> 
> And still, it's not officially approved for hair loss, and it's been years since the approval process started. Why is this drug any different?
> 
> Cotsareli's involvement is not a guarantee of success. He also had some success with wounding and lithium almost a decade ago and that lead nowhere, any attempt from forum members to replicate those results failed


 It's not new in terms of development with the FDA. That's what's counts. Drugs that have been commercialized have made it through fda trials, which is why they've been released. This drug hasn't been released as anything else because what it was originally intended for (asthma) didn't have much of an effect. Nevertheless, it has been through 8 clinical trials, including a phase 3.  This drug would be different because there would be no sexual side effects, plus women would be able to use it. 

Cotsarelis is one of the most (if not the most) knowledgable doctors in hair research. This is his work, and he sold the rights to have it developed. If you read the presentation, it says that everything is in place for it to be a successful and efficient program towards commercialization. Lol why am I going back and forth with you, you don't even know his name, you keep calling him "Cotsareli"

----------


## bigentries

> It's not new in terms of development with the FDA. That's what's counts. Drugs that have been commercialized have made it through fda trials, which is why they've been released. This drug hasn't been released as anything else because what it was originally intended for (asthma) didn't have much of an effect. Nevertheless, it has been through 8 clinical trials, including a phase 3.  This drug would be different because there would be no sexual side effects, plus women would be able to use it. 
> 
> Cotsarelis is one of the most (if not the most) knowledgable doctors in hair research. This is his work, and he sold the rights to have it developed. If you read the presentation, it says that everything is in place for it to be a successful and efficient program towards commercialization.


 But again, those trials failed. We don't have any information about hair regrowth from those trials.

Dutasteride is considered efficient by anyone in the scientific community, and still hasn't received approval as a hair loss treatment. Why would a drug with failed trials and no assurance of efficacy as a hair loss treatment would have better luck than dutasteride?

And beware about any company promises. If you haven't, please read the archives from the Intercytex and Aderan efforts. People here and elsewhere even went to the point of cancelling HTs and making projected milestones timelines because they were told "that everything is in place for it to be a successful and efficient program towards commercialization.". Seriously, even Aderans had plans to roll out the treatment in Bosley clinics

Also, remember Follica. It's Cotsaserlis company too and it's been a decade of disappointments.

I think it's too early for this level of excitement

----------


## It's2014ComeOnAlready

> But again, those trials failed. We don't have any information about hair regrowth from those trials.
> 
> Dutasteride is considered efficient by anyone in the scientific community, and still hasn't received approval as a hair loss treatment. Why would a drug with failed trials and no assurance of efficacy as a hair loss treatment would have better luck than dutasteride?
> 
> And beware about any company promises. If you haven't, please read the archives from the Intercytex and Aderan efforts. People here and elsewhere even went to the point of cancelling HTs and making projected milestones timelines because they were told "that everything is in place for it to be a successful and efficient program towards commercialization.". Seriously, even Aderans had plans to roll out the treatment in Bosley clinics
> 
> Also, remember Follica. It's Cotsaserlis company too and it's been a decade of disappointments.
> 
> I think it's too early for this level of excitement


 I don't think you understand all of the information and circumstances. Those trials did not fail, the trials went fine, the drug wasn't commercialized because it didn't work for asthma. 

Dutasteride has nothing to do with this. 

These are not company promises, this is based on all the information in their presentation, if you actually took the time to read it. 

Cotsarelis and Follica have been working for a decade on this and follicle neogenesis. He's sold to a pharmaceutical company so they can develop a new treatment based on all his work. A company is paying to do the trial based on the working hypothesis of the leading hair researcher in the world. They are taking on the cost, which means they believe in it. Companies do not trial drugs, especially drugs that have been through this many trials, unless it is highly likely to succeed and be commercialized. 

It's not too early for this level of excitement if you understand what's going on, and how Cotsarelis' work has gotten to this point.

----------


## HairlossAt15

Half of you are incredible whiners.. The other half, are selfish and inpatient, wanting the product right now by any method and any means. No doubt if you got it and cured your hair loss, you would never come on these forums and help other  people out... Time to grow up, this is the most promising news in the last decade at least, in 2012 cotsarelis said trials would start within 2 years, they started In 2013..just one year(they said they have been testing for 2 years already) ! Turns out he is honest after all..

----------


## burtandernie

If there ever was a time to be positive about some amazing news that came out of nowhere it would be now. You just need some patience. I would feel a little better once we see a little more about how well it works and what sides might emerge later on. This though might be the biggest news in a long time. It might get good regrowth and you throw BIM in the mix you might get a lot of hair back for the first time in history

----------


## walrus

An open access publication on how the drug is metabolised: http://link.springer.com/article/10....268-013-0031-7

----------


## It's2014ComeOnAlready

> An open access publication on how the drug is metabolised: http://link.springer.com/article/10....268-013-0031-7


 pee and poo. No sides.

----------


## Gerhard

> pee and poo. No sides.


 In other trials it supposedly came back with headaches and some other side effects which I would determine to be rather mild to insignificant. This is good news though. I'm being tentative and cautious with how much optimism I allow myself to feel due to the nature of some individuals posts in this thread. Remember guys, just because their words aren't good news doesn't make them invalid. I'm happy to hear any update good or bad (but primarily good). From what I've read so far we need more time to pass to allow Kythera to showcase their efficacy. In the link to their interview I heard very little discussion on Setipriprant as it mostly focused on their cosmetic injection filler. 

We will have to wait for an update as to where they stand on FDA testing. Funding however, thankfully, seems to be less of an issue with Kythera so far. They make it sound affordable and relatively inexpensive for them which means we won't have to deal with as many stalls. I do hope that this does offer a new treatment, but I am making sure not to put too much hope into this. CB showed me how quickly hope can become despair if left there too long. Speaking of CB has anyone actually found a proper vehicle and found conclusive evidence of its efficacy yet?

----------


## sdsurfin

that link has nothing to do with sides. also i don't think short term sides will be a huge issue.  I do think long term sides will be ****ed, if you do your research on other histamine receptor blockers, people go through really horrid withdrawals after trying to stop after long term use.  I guess we can cross our fingers that more selective PGD2 blockers won't do the same, but my hopes are not high.  Would love to talk to a doctor or researcher about this.

----------


## Gerhard

> that link has nothing to do with sides. also i don't think short term sides will be a huge issue.  I do think long term sides will be ****ed, if you do your research on other histamine receptor blockers, people go through really horrid withdrawals after trying to stop after long term use.  I guess we can cross our fingers that more selective PGD2 blockers won't do the same, but my hopes are not high.  Would love to talk to a doctor or researcher about this.


 I'll do some research on them tonight and get back to you. Although I hate the fact that balding struck me and especially at such a young age I can at least admit that it's made me more interested in the science behind dermatological issues such as hair loss and has made me even consider tackling it as a potential career choice if I can manage. For now, I'll leave this thread with this: I hope that by having a more selective blocker that they will enable a less side effect riddled treatment that propecia. Honestly, while I may be taking this, I have come to grips with the fact that what I'm putting in my body for vanity's sake is toxic. While I am cautious for side effects in these PGD2 blockers I would say I'd be more willing to experiment and trial them than I ever would be and am with propecia. The hormonal effects of propecia just seem so much more catastrophic if they come to fruition.

I would also like to say to you personally, sdsurfin, that while your words haven't been widely appreciated in this or a few other topics that I am grateful for your presence and posts on these forums. While we may not want to hear about the potential of ineffective or bum treatments, it is important that we are notified of the possibility of these not coming to bear. 

Hopefully Setipriprant will blow us all away. For now I'll remain cautiously optimistic.

----------


## Pentarou

> Half of you are incredible whiners.. The other half, are selfish and inpatient, wanting the product right now by any method and any means. No doubt if you got it and cured your hair loss, you would never come on these forums and help other  people out... Time to grow up, this is the most promising news in the last decade at least, in 2012 cotsarelis said trials would start within 2 years, they started In 2013..just one year(they said they have been testing for 2 years already) ! Turns out he is honest after all..


 Honestly, I feel optimistic for the future for the first time since about July 2013. Yes, there are still a lot of hurdles ahead, let's be realistic, but otherwise I can't see this as anything but a promising step forward.

----------


## sdsurfin

thanks man.  I'm just trying to help and be realistic. I wish we could just gene edit already and be done with this crap, it's so unfair.  See if you can research and ask people whether blocking this receptor long term will cause withdrawal like with zyrtec.  Unfortunately i cnt find a contact email for kythera, if i was in san diego i would try to talk to the lead researcher. i think hoping for a side effect free drug is silly though.  its amazing that people take propecia without side effects, and I'm not sure this kind of receptor blocker is really good for long term use.

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## Gerhard

> thanks man.  I'm just trying to help and be realistic. I wish we could just gene edit already and be done with this crap, it's so unfair.  See if you can research and ask people whether blocking this receptor long term will cause withdrawal like with zyrtec.  Unfortunately i cnt find a contact email for kythera, if i was in san diego i would try to talk to the lead researcher. i think hoping for a side effect free drug is silly though.  its amazing that people take propecia without side effects, and I'm not sure this kind of receptor blocker is really good for long term use.


 I'm sure all of us wish gene editing was a thing, but that's something I doubt we'll ever live to see. I plan on going to the laboratories tomorrow to actually discuss it with one of the biology professors. I'm curious if they have any insight. 
Kythera's email is located on their website, but they seem to only take them if you're a certified healthcare professional. Otherwise they seem to mandate a call. I would agree with you about a side effect free drug, but the aim so far is to find a drug with a more limited amount of side effects with a lower rate of eventually having them.

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## sdsurfin

Please ask your professor about Zyrtec and Claritin withdrawal (if you look online most people who take antihistamines long term seem to get it) and ask if this might cause similar problems. If this doesn't carry that risk then sleepiness and headaches might be the worst you get from it.

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## walrus

If a drug works, technically it is a side effect, only it happens to be a desirable one.

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## Thinning@30

> Although I hate the fact that balding struck me and especially at such a young age I can at least admit that it's made me more interested in the science behind dermatological issues such as hair loss


 Great comment.  I think I know what you mean.  I feel like ever since I started balding, I've learned so much about the clinical trial process, the regulatory environment, and the science involved in hair loss, aging, and dermatology issues.  As much as it sucks to be going through hair loss, I feel like it has helped me understand the medical and pharmaceutical industries, and I hope it will help me evaluate scientific and medical claims more effectively.

----------


## Slam1523

> Please ask your professor about Zyrtec and Claritin withdrawal (if you look online most people who take antihistamines long term seem to get it) and ask if this might cause similar problems. If this doesn't carry that risk then sleepiness and headaches might be the worst you get from it.


 That is so strange to me that those allergy medications have that affect...  I had taken zyrtec for years, and went off of it for the past 9 months, and haven't noticed a single side...  Crazy to think it can be tied to things like depression and headaches!

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## Gerhard

> Please ask your professor about Zyrtec and Claritin withdrawal (if you look online most people who take antihistamines long term seem to get it) and ask if this might cause similar problems. If this doesn't carry that risk then sleepiness and headaches might be the worst you get from it.


 I am very interested in this myself due to your postings and will definitely inquire upon it when talking to the professor tomorrow. 




> Great comment.  I think I know what you mean.  I feel like ever since I started balding, I've learned so much about the clinical trial process, the regulatory environment, and the science involved in hair loss, aging, and dermatology issues.  As much as it sucks to be going through hair loss, I feel like it has helped me understand the medical and pharmaceutical industries, and I hope it will help me evaluate scientific and medical claims more effectively.


 I couldn't have phrased that better myself. The amazing thing is is that I've never even considered a career in the medical field before I began whimsically desired to cure myself and others of hair loss. Now it's actually turned into a bit of a pastime and I find myself reading a lot of dermatologic medical journals and scholarly articles. The ironic part is is that when I tried to discuss some of these findings that some people toss around and describe so easily with my dermatologist and a few other dermatologists you quickly begin to understand how little understanding they have in their own field. As you've said it's also been easier to evaluate all medical findings. I hate AGA, I truly, truly do and I would wish it upon no one. It has, however, opened my eyes to a possible career choice and an avenue for achieving it. Whether I'll take it or not remains to be soon. I certainly do hope that by the time I'm old enough to make an impact on the hair loss field that it will already be a thing of the past.




> That is so strange to me that those allergy medications have that affect...  I had taken zyrtec for years, and went off of it for the past 9 months, and haven't noticed a single side...  Crazy to think it can be tied to things like depression and headaches!


 Agreed. I'm not too keen on rereading the articles all over again currently, but due to sdsrufin's contributions I am hoping that Setipriprant will bind to receptors just enough to limit PGD2 to normal scalp levels. Otherwise this treatment will need some fine tuning.

----------


## Allowme

This is what I got from reading this thread.
This will be an alternative to propecia but not necessarily something that will replace it. It was quoted that this is better than propecia, but by how much? I think we would have heard something if its efficacy was markedly better than propecia from all those clinical trials for asthma.  And the fact they want to use bim for regrowth makes me believe their efficacy will be somewhat similar. This will definitely benefit people who gets sides from propecia, but not from this drug. But I won't expect it to be much better than propecia. And also cb may be a better alternative with less side effects in the future.
The more interesting question is will you grow more hair if you use this with propecia? There's no way to answer this without a clinical trial, but I feel that there won't be much difference. I know very little about science behind this, but someone mentioned they are part of the same chain, pgd2 is just lower level of that chain. But let's say there is an improvement from using them together. How much improvement does there have to be before it makes sense to use them together? You will be faced with added side effects and costs.
Not to say I'm not excited about this news. More options are always welcome. Some people will definitely benefit from this, especially for women who haven't had real trestment option before this. But I'm not expecting a cure. Also, the most interesting thing from this is that they sound very confident about bim. perhaps bim in conjunction with this drug and/or with dht antagonists will yield good result.

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## RGPHILPA

> This is what I got from reading this thread.
> This will be an alternative to propecia but not necessarily something that will replace it. It was quoted that this is better than propecia, but by how much? I think we would have heard something if its efficacy was markedly better than propecia from all those clinical trials for asthma.  And the fact they want to use bim for regrowth makes me believe their efficacy will be somewhat similar. This will definitely benefit people who gets sides from propecia, but not from this drug. But I won't expect it to be much better than propecia. And also cb may be a better alternative with less side effects in the future.
> The more interesting question is will you grow more hair if you use this with propecia? There's no way to answer this without a clinical trial, but I feel that there won't be much difference. I know very little about science behind this, but someone mentioned they are part of the same chain, pgd2 is just lower level of that chain. But let's say there is an improvement from using them together. How much improvement does there have to be before it makes sense to use them together? You will be faced with added side effects and costs.
> Not to say I'm not excited about this news. More options are always welcome. Some people will definitely benefit from this, especially for women who haven't had real trestment option before this. But I'm not expecting a cure. Also, the most interesting thing from this is that they sound very confident about bim. perhaps bim in conjunction with this drug and/or with dht antagonists will yield good result.


 
Well they specifically state in their presentation that they'll be using a novel (patented) technique that Upenn owns the rights to for delivering the drug.  Nobody as of yet knows what that novel delivery approach is.  So, you can't look at the allergic rhinitis trials and conclude that there will be minimal results for this compound or even have any idea of how effective it could be.  This could and should be an entirely different approach.

And if I can engage in a bit of speculation.... I want to point out that one of the novel delivery techniques that Cotsarelis and Upenn have patented, are the wounding protocols that Follica was working on.  Upenn has rights to that as well as Follica.  Maybe we'll see another licensing deal (which I'm not even sure they need since they're on the patent) go through and this PGD2 compound will be used in conjunction with wounding.  That would be a game changer for sure.   And there is the not so small coincidence that Follica went silent and laid off their staff right around the time that Kythera, Cotsarelis and Upenn were entering into contracts  - approximately two years ago.  Right at a time when Bernat Olle from follica was saying they could generate significant hair growth.  It makes no sense for them to say that and then go dead and layoff staff unless there was a significant change of direction in their business plan, such as I'm suggesting here.

I would love for that to be true, though I conceded that it may be wishful thinking.

----------


## RGPHILPA

Also, a bit more evidence supporting my speculation...

Follica has posted Cotsarelis's talk at the World Congress for Hair Research on their web page.  The bulk of that talk is about PGD2 and it's role in MPB.  He even specifically states that an antagonist could be therapeutically effective for treating baldness.   If this recent deal was engaged in outside of Follica's interests (i.e. this recent Kythera development doesn't involve them) why would they post that talk on their website?  Clearly Cotsarelis was already involved with Kythera long before that talk was given.  So, something is up... 

Coincidence or something else?

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## kaptainjack

Even if it turns out to be _only_ as good as Finasteride but without any of the sexual side effects, it's a winner in my books.

----------


## It's2014ComeOnAlready

Let me make this clear to anyone reading this thread: This drug will have NO sexual side effects, NONE. This drug will be more effective than propecia because PGD2 is more causal to hair loss than DHT is. Propecia doesn't even block all DHT, so some PGD2 is still elevated downstreatm in the scalps of men who are using propecia.

IF you want to understand the relationship between DHT and PGD2 look at page 8 of this presentation:http://files.shareholder.com/downloa...0Deck%209FEB15

Enough of the "is it gonna be more effective than propecia? Will it have the sides?" YES IT WILL BE MORE EFFECTIVE. NO, THERE WILL BE NO SEXUAL SIDE EFFECTS because there were none in healthy men and women taking oral doses.

----------


## Parsia

> Let me make this clear to anyone reading this thread: This drug will have NO sexual side effects, NONE. This drug will be more effective than propecia because PGD2 is more causal to hair loss than DHT is. Propecia doesn't even block all DHT, so some PGD2 is still elevated downstreatm in the scalps of men who are using propecia.
> 
> IF you want to understand the relationship between DHT and PGD2 look at page 8 of this presentation:http://files.shareholder.com/downloa...0Deck%209FEB15
> 
> Enough of the "is it gonna be more effective than propecia? Will it have the sides?" YES IT WILL BE MORE EFFECTIVE. NO, THERE WILL BE NO SEXUAL SIDE EFFECTS because there were none in healthy men and women taking oral doses.


 Ok thanks for make it clear to us , would you please tell me when do you think ( estimation ) this product would be available in market? 

Should we wait at least 3 years you think?

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## Jonathan

> Let me make this clear to anyone reading this thread: This drug will have NO sexual side effects, NONE. This drug will be more effective than propecia because PGD2 is more causal to hair loss than DHT is. Propecia doesn't even block all DHT, so some PGD2 is still elevated downstreatm in the scalps of men who are using propecia.
> 
> IF you want to understand the relationship between DHT and PGD2 look at page 8 of this presentation:http://files.shareholder.com/downloa...0Deck%209FEB15
> 
> Enough of the "is it gonna be more effective than propecia? Will it have the sides?" YES IT WILL BE MORE EFFECTIVE. NO, THERE WILL BE NO SEXUAL SIDE EFFECTS because there were none in healthy men and women taking oral doses.


 Give the CTO at Kythera a call before they start their proof-of-concept trial. Its will be a waste of time and money since you already got all the answers.

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## sdsurfin

why are sexual side effects the only important side effects? It sounds like if a drug turned your face into a goats face but left your libido intact you would still take it happily. I think constant headaches and feeling asleep all the time are just as bad if not worse.  Propecia never ****ed up my sex drive too bad, but it did make me feel braindead.  your brain is really the thing that matters most.

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## It's2014ComeOnAlready

> Give the CTO at Kythera a call before they start their proof-of-concept trial. Its will be a waste of time and money since you already got all the answers.


 It would be extremely helpful if you just read the presentation. I'm not saying the drug works, I'm saying that if it does, it would have no sexual side effects, and would theoretically be more effective than propecia. This is also based on years or research and trials. Keep listening to sdsurfin, the fear-mongering denialist. Like the fox news of hair loss message boards.

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## bigentries

> I'm not saying the drug works


 You are saying that, read your posts more carefully. In your last post you affirmed the drug will work, will not have sexual side effects and will work better than propecia.

Don't you think you are getting too attached? Are you really a 2014 user? You should really read the archives to see how some guys get too attached to any treatment that brought hope

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## It's2014ComeOnAlready

> You are saying that, read your posts more carefully. In your last post you affirmed the drug will work, will not have sexual side effects and will work better than propecia.
> 
> Don't you think you are getting too attached? Are you really a 2014 user? You should really read the archives to see how some guys get too attached to any treatment that brought hope


 They said the drug works in vitro, because they studied it in hair chemical pathways. It does not have sexual side effects because it was tested on hundreds of healthy men and women in an oral form, and there were no reportings. Theoretically, it will be more effective than finasteride because PGD2 is further downstream of DHT. Finasteride doesn't block all DHT, and therefore doesn't block the creation of excess PGD2. 

I've been posting on this forum since 2014, but have been reading for much longer.

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## hellouser

> They said the drug works in vitro, because they studied it in hair chemical pathways. It does not have sexual side effects because it was tested on hundreds of healthy men and women in an oral form, and there were no reportings. Theoretically, it will be more effective than finasteride because PGD2 is further downstream of DHT. Finasteride doesn't block all DHT, and therefore doesn't block the creation of excess PGD2. 
> 
> I've been posting on this forum since 2014, but have been reading for much longer.


 Finasteride along with Setipiprant and Minox should yield some impressive results. I wonder what we can get in combination with Histogen/Replicel should either of them come to fruition.

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## sdsurfin

> They said the drug works in vitro, because they studied it in hair chemical pathways. It does not have sexual side effects because it was tested on hundreds of healthy men and women in an oral form, and there were no reportings. Theoretically, it will be more effective than finasteride because PGD2 is further downstream of DHT. Finasteride doesn't block all DHT, and therefore doesn't block the creation of excess PGD2. 
> 
> I've been posting on this forum since 2014, but have been reading for much longer.


 In vitro is not the same as in vivo.  Also, PGD2 is not the only cause of hairloss.  You have no idea how it works compared to propecia, nor do they really.  blocking DHT is actually potentially more effective BECAUSE it is upstream, and blocks any and all interactions that are downstream.  By blocking PGD2, you are only blocking one of the things that DHT unleashes.  My personal informed take is that this will be quite effective at stopping hair loss (basing this on trials of very similar compounds run by forum users, and by the way that this pathway works). I don't think much regrowth will occur.  Combining with another drug might be very good for stopping hairloss and gaining back hair, but the question becomes how many and how severe are the side effects form one or both of these drugs.  From the safety trials I'm not too optimistic, and trust me I would like to be.  But 25% of people getting headaches is a lot of side effects, and if the drug is this potent an antihistamine, I'm almost positive it won't be great for you long term.  Again, I could be wrong.  This is going to have to be tested long term with dosing trials.  I think the best thing we can take from this is that someone researched hair loss, and a company acted on it. first time in history.

----------


## It's2014ComeOnAlready

> In vitro is not the same as in vivo.  Also, PGD2 is not the only cause of hairloss.  You have no idea how it works compared to propecia, nor do they really.  blocking DHT is actually potentially more effective BECAUSE it is upstream, and blocks any and all interactions that are downstream.  By blocking PGD2, you are only blocking one of the things that DHT unleashes.  My personal informed take is that this will be quite effective at stopping hair loss (basing this on trials of very similar compounds run by forum users, and by the way that this pathway works). I don't think much regrowth will occur.  Combining with another drug might be very good for stopping hairloss and gaining back hair, but the question becomes how many and how severe are the side effects form one or both of these drugs.  From the safety trials I'm not too optimistic, and trust me I would like to be.  But 25% of people getting headaches is a lot of side effects, and if the drug is this potent an antihistamine, I'm almost positive it won't be great for you long term.  Again, I could be wrong.  This is going to have to be tested long term with dosing trials.  I think the best thing we can take from this is that someone researched hair loss, and a company acted on it. first time in history.


 You are spewing utter nonsense. I'm done responding to you.

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## sdsurfin

> You are spewing utter nonsense. I'm done responding to you.


 You're a moron.  People can decide for themselves if what I'm saying is nonsense. My father is a dermatologist and I'm a biology major.  None of what I'm saying is anything more than informed and knowledgeable speculation.  I hope I'm wrong, I really do. Even if I'm right I'm sure there will be lucky people who can use this without consequence, there always are. I've tried contacting these guys to no avail. Best bet would be for someone in cali to make an appointment to see the head of research who is a dermatologist.

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## Illusion

Meh gotta side with sdsurfin on this one I guess. I'm glad that we're moving forward and I'm not going to make any guesses/assumptions about its efficacy and sides. But IF it could give the same sides like antihistamines (sleepinness, drowsiness and headaches) then that's a pitty really. Ofcourse it's to each his own to say "I'd prefer x side over y side" but personally, I think being sleepy most of the time and having frequent headaches will drastically decrease the quality of ones life. But we will see, let's wait for the trials first.


@sdsurfin, you were talking about the withdrawal effect of antihistamines but the withdrawal effect in itself shouldn't be that much of a problem right? I don't know how frequently we have to apply this, but if we would have to apply this every day for the rest of our lives, then we wouldn't ever have a withdrawal effect right?

But there are obv the sides, which could suck. I've read about that drowsiness caused by antihistamines before and it didn't seem like it was something you could come to terms with and live with the rest of your life

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## sdsurfin

> Meh gotta side with sdsurfin on this one I guess. I'm glad that we're moving forward and I'm not going to make any guesses/assumptions about its efficacy and sides. But IF it could give the same sides like antihistamines (sleepinness, drowsiness and headaches) then that's a pitty really. Ofcourse it's to each his own to say "I'd prefer x side over y side" but personally, I think being sleepy most of the time and having frequent headaches will drastically decrease the quality of ones life. But we will see, let's wait for the trials first.
> 
> 
> @sdsurfin, you were talking about the withdrawal effect of antihistamines but the withdrawal effect in itself shouldn't be that much of a problem right? I don't know how frequently we have to apply this, but if we would have to apply this every day for the rest of our lives, then we wouldn't ever have a withdrawal effect right?
> 
> But there are obv the sides, which could suck. I've read about that drowsiness caused by antihistamines before and it didn't seem like it was something you could come to terms with and live with the rest of your life


 Well the problem is that with things like zyrtec, they often lose their effectiveness over time.  To keep having the same effect you have to take more and more, and that can be damaging to your body, not to mention with higher doses you get more sides. Then when people try to quit they go through major withdrawals. The problem is that the receptor that you are blocking is not just used in your body for hair, just like 5ar enzyme has many purposes besides killing hair.  The good thing is that if you can tough the withdrawal out you might not be permanently affected, as happens with some propecia users. Could maybe take this for ten years and then go through a really shitty month or so of quitting. It's less of a risk to take than permanently killing your dick.  Hopefully withdrawals from this would be rare (and i think topical applications are usually less absorbed as a whole, despite naysayers), and hopefully the side effects are tolerable.  Really I'm more scared that it will be a great drug but that most of us won't be able to use it.  I can't even use minox because it gives me awful raccoon bags under my eyes, and if 25 percent of people are getting headaches and sleepiness from Pip (I'm officially abbreviating setipiprant to pip cause that shit is hard to type and remember) then it doesn't bode well for many of us.  Keep your fingers crossed.  Replicel is in phase 2, so you might have a better option by the time this comes out anyway.

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## HairlossAt15

Lmao cotsaerlis spells out in his studies how big of a impact pgd2 has on hair growth. Then the Kythera presentation translates it into laymen terms. Human hairs grows as normal when pgd2 effect is removed, simple as that.

Headaches are normal side effects in any trial... Probably just placebo effect from paranoid testers...

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## Gerhard

> You are spewing utter nonsense. I'm done responding to you.


 2014, we're all as hopeful and as excited as you on the development of this drug. However, you need to accept that sdsurfin has made some valid and very real points. While we may not want to hear them, they are possibilities that must be considered, weighed, and remind ourselves of. Not everything is perfect. His points on the effects of prolonged antihistamine usage is valid. Be respectful, please. We're all brothers in the hairloss boat.




> You're a moron.  People can decide for themselves if what I'm saying is nonsense. My father is a dermatologist and I'm a biology major.  None of what I'm saying is anything more than informed and knowledgeable speculation.  I hope I'm wrong, I really do. Even if I'm right I'm sure there will be lucky people who can use this without consequence, there always are. I've tried contacting these guys to no avail. Best bet would be for someone in cali to make an appointment to see the head of research who is a dermatologist.


 Remember, we're all brothers in this. No need to be name calling and such. We're all old enough to avoid that. I think your points are valid and useful and I'm happy that you've presented them. Whether it's good or bad news all news is important to gauge the possible efficacy of these future treatments and if we have reason to be wary or concerned.

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## sdsurfin

> 2014, we're all as hopeful and as excited as you on the development of this drug. However, you need to accept that sdsurfin has made some valid and very real points. While we may not want to hear them, they are possibilities that must be considered, weighed, and remind ourselves of. Not everything is perfect. His points on the effects of prolonged antihistamine usage is valid. Be respectful, please. We're all brothers in the hairloss boat.
> 
> 
> 
> 
> 
> Remember, we're all brothers in this. No need to be name calling and such. We're all old enough to avoid that. I think your points are valid and useful and I'm happy that you've presented them. Whether it's good or bad news all news is important to gauge the possible efficacy of these future treatments and if we have reason to be wary or concerned.


 true and my bad, I didn't start the name calling but I should just ignore it.

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## sdsurfin

> Lmao cotsaerlis spells out in his studies how big of a impact pgd2 has on hair growth. Then the Kythera presentation translates it into laymen terms. Human hairs grows as normal when pgd2 effect is removed, simple as that.
> 
> Headaches are normal side effects in any trial... Probably just placebo effect from paranoid testers...


 ? I don't even know if you read any of what I wrote.  Everything you say is true but it has nothing to do with what I'm warning people about.  Just because a drug works doesn't mean it's gonna be pleasant or worth it to take. And we don't even know if it works.  Kythera are taking an informed gamble on something tested in vitro and with a good theory behind it.  That doesn't mean this drug is the perfect way to implement that knowledge.  Blocking the DHT pathway is even better but we still haven't gotten the perfect drug to deal with that. Just saying we are in very preliminary areas, and tbh hair growth was not an astounding aspect of any of their past trials, so IMO it's def not a miracle cure.  Millions of people take zyrtec or claritin, but they are warned not to take it for too long.  This was not a warning or an issue in the trials for these drugs, and many doctors don't even know that you can withdraw from them, but it's possible and maybe probable after long enough use. Even if you don't withdraw, being exhausted and headachy and farting all the time is pretty awful.  And no headaches weren't a placebo effect, at 25%. thats too many people to just make something up. Not to mention its a well documented major side effect of other antihistamines.  If you can't understand what I'm saying then just forget about it.  I would like the people that do understand to ask knowledgeable people and scientists what they think. that's all.

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## Gerhard

> true and my bad, I didn't start the name calling but I should just ignore it.


 It's all good, brother. We can all get frustrated sometimes. Trust me, I am definitely not a paragon of calmness or anything! But I can understand why tension can run high in this. We all put our faith and trust into something and we hope that it works out, but the reality is that even if it is a milestone there are a lot more factors before it can be a success. Some people see that and some people don't want to. We all just have to remember that the best thing we can do is work together and update with beneficial questions, concerns and progress.




> ? I don't even know if you read any of what I wrote.  Everything you say is true but it has nothing to do with what I'm warning people about.  Just because a drug works doesn't mean it's gonna be pleasant or worth it to take. And we don't even know if it works.  Kythera are taking an informed gamble on something tested in vitro and with a good theory behind it.  That doesn't mean this drug is the perfect way to implement that knowledge.  Blocking the DHT pathway is even better but we still haven't gotten the perfect drug to deal with that. Just saying we are in very preliminary areas, and tbh hair growth was not an astounding aspect of any of their past trials, so IMO it's def not a miracle cure.  Millions of people take zyrtec or claritin, but they are warned not to take it for too long.  This was not a warning or an issue in the trials for these drugs, and many doctors don't even know that you can withdraw from them, but it's possible and maybe probable after long enough use. Even if you don't withdraw, being exhausted and headachy and farting all the time is pretty awful.  And no headaches weren't a placebo effect, at 25%. thats too many people to just make something up. Not to mention its a well documented major side effect of other antihistamines.  If you can't understand what I'm saying then just forget about it.  I would like the people that do understand to ask knowledgeable people and scientists what they think. that's all.


 For now we'll just have to wait and see what results they publish in the future and hope for the best. A lot of people will prefer to only look at the presentation pdf rather than also take the critiques you've posted as well. Again, thanks for posting them though. You've made me more aware of the situation and helped me determine what questions we should be asking of Kythera and trying to learn more about.

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## sdsurfin

Yeah I really wish someone would take the initiative to schedule an appointment with the guy in san diego, it would be very easy to do and might elucidate a lot.  I know there are guys in cali on this forum. Regrettably cotsarellis is very hard to contact if not impossible, as is garza.  

We could very well be one of the luckiest generations as far as hair loss is concerned, but it will def come at a price. We will probably see a better maintenance option than propecia in our time, and the next generation will likely get a pretty full cure.  Between Prip and Bim and SM and replicel and CB something is gonna pan out, likely we will see a precentor drug and a growth drug, and probably a lot of guys will be able to handle the sides.  This won't be a done, side free deal until they figure out gene editing, which will take a long long time. Even making new follicles, which is likely to happen in the next 20 yrs, will not be successful without medications that keep it going, and that means sides.  

I think the best we can do is join forces and push for drug companies to be honest and to make either topical versions or oral formulations that truly take our health into consideration.  I'm pretty pissed that we don't have a topical AA at this point, because there are several candidates better than CB, and I hope this pGD2 stuff won't stop them from being developed. they have less chance of causing sides than medications that **** with our immune receptors.

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## HairlossAt15

We are not on the same page, I have read all the papers from Cotsarelis and Garza and have a firm understanding of the Science and trial process.

First lets clarify how powerful placebo is: 

"In the 1950's a man dying of advanced cancer learned of an experimental drug called krebiozen, which many people considered a miracle cure for cancer. The man desperately insisted he be given it. After a single dose his huge cancers "melted like snowballs on a hot stove" and he was able to resume normal activities.

Then disaster struck. Studies of krebiozen showed it to be ineffective, and when the man read this his cancer once again began spreading. At this stage his doctor tried an experiment. He announced that there was a new, "improved" krebiozen and the patient would now receive it. Once again the man's tumors shrank. Yet in fact the doctor had given him only water. [Case was reported in a medical journal in 1957]"

Now lets look at the side effects

Major : none!

Minor:

Headache (25%) : You cant record a headache with any apparatus, in trials the patients are simply asked "Did you feel any adverse effect e.g headache etc" (or something similar to that).To which people give their answer, for absolute transparency, these are noted down as official side effects.. even though you have no idea if it was the drug. It could be from any of these things : anger, frustration, dehydration, exhaustion (end of a hard week) etc etc. You can also easily talk yourself into a headache from paranoia. Just like you can talk yourself into stress, sadness etc.

Flatulence (15%) : Interesting one, but again hard to measure and confirm it is related to the drug, could just be from eating bad food etc. The patients are knowingly taking an "experimental" drug, leads to fear in some people - when I was young and naive I used to get sick to my stomach just when taking pain killers(before I even took them and then got worse after), just didnt like pills at all, would be afraid after taking it, leading to feeling sick to my stomach and puking a few times. 

Somnolence and fatigue (10%) : Fatigue? You mean the feeling you have after a hard day at work? Come on guys, impossible to relate this to the drug. "10%" thats about the percentage of people who are depressed/stressed out all the time. Not even significant in any way.

I never said this was the cure, but it could very well be after some tinkering and adding some growth factors to.

"To test the effect of PGD2 on human hair growth, we used explanted human hair follicles maintained in culture for 7 days. We added increasing amounts (from 0 to 10 μM) of PGD2, 15-dPGJ2, or vehicle to the culture medium and measured hair length (Fig. 6D). Starting at 5 μM, PGD2 and 15-dPGJ2 significantly inhibited hair growth. At 10 μM, PGD2-treated hair was 62 ± 5% shorter than vehicle, whereas 10 μM 15-dPGJ2 completely inhibited all hair growth. We tested a variety of other PGD2 analogs and found them to be capable of inhibiting hair lengthening."




> Blocking the DHT pathway is even better


 How so? I think that will lead to far worse side effects..




> This was not a warning or an issue in the trials for these drugs, and many doctors don't even know that you can withdraw from them, but it's possible and maybe probable after long enough use.


 Good to see you are smarter than doctors. "Withdrawals", people say they get that from eating less chocolate..also its not a complicated concept, dont know why your making it out to be so..




> If you can't understand what I'm saying then just forget about it.  I would like the people that do understand to ask knowledgeable people and scientists what they think. that's all.


 How pretentious...

----------


## Thinning87

I gotta say, sdsrufin brings up good points from time to time but he often goes way too far in his judgements. It's like he always knows everything that is going on behind the scenes in any company or lab. Any time there is an announcement by someone in the hairloss community you be he'll be here making his predictions. He called me a troll when I announced my roommate and my good friend's names were on the Sanford Burnham paper a few weeks ago. I reported what they told me personally and he insisted that I was full of it. Then he totally changes his mind days later when he reads the paper in more depth. 

For once, sdsrufin you can just stop talking about everything because you're just another amateur poster on some forum. Please try to find something other than spamming the entire forum with your judgements about things you obviously don't know anything about.

----------


## unbalding

The concern for me is does your body compensate by increasing PGD2 further or producing more PGD2 receptors, thus making a permanent treatment more difficult when that comes along.

----------


## It's2014ComeOnAlready

> Finasteride along with Setipiprant and Minox should yield some impressive results. I wonder what we can get in combination with Histogen/Replicel should either of them come to fruition.


 I honestly believe there is a race to get setipiprant, as well as bimatoprost out there. You won't need anything else, treatment wise. One will stop hair loss, and the other will regrow spots you need it in. That's it. That's one of the reasons I find this very exciting.

----------


## It's2014ComeOnAlready

I would also like to make clear why I am so gung ho about this development. Cotsarelis has been working on the PGD2 thing since 2007, and he has selected a particular drug (one that has been exhausted in clinical trials) and a company to trial and produce it. 

It says that 5 drugs worked in this pathway, but they chose this one because of it's efficacy with hair, but also because of how studied it is. This is not some company taking a chance at a potential new hair loss drug. All the hard work has been done, and they want to commercialize this as soon as possible. All the steps and measures have already been taken to ensure that this will work and they'll be successful. The trial is the least daunting part about it. 

Other doctors, news outlets, Cotsarelis himself have always been very confident about this. We should be too if a pharmaceutical company wants to produce it. Companies don't put on more clinical trials with a drug that hasn't worked for something else, unless it surely works for something they can commercialize it for.

----------


## unbalding

> I honestly believe there is a race to get setipiprant, as well as bimatoprost out there. You won't need anything else, treatment wise. One will stop hair loss, and the other will regrow spots you need it in. That's it. That's one of the reasons I find this very exciting.


 Theoretically, but people have tried similar treatments that are already available with little to no success. I don't see how setipiprant should be any better than ramatroban. There are a substantial number of people out there who have used that along with various pgf2 analogues, and no miracle results have been reported. I myself just started using ramatroban today along with bimataprost .03%, and will start using D-cloprostenol next week. I'd love to try a higher concentration of bimataprost or latanaprost if I could find a reasonable price on quality powder.

----------


## It's2014ComeOnAlready

> Theoretically, but people have tried similar treatments that are already available with little to no success. I don't see how setipiprant should be any better than ramatroban. There are a substantial number of people out there who have used that along with various pgf2 analogues, and no miracle results have been reported. I myself just started using ramatroban today along with bimataprost .03%, and will start using D-cloprostenol next week. I'd love to try a higher concentration of bimataprost or latanaprost if I could find a reasonable price on quality powder.


 So, you're doubting that this will work at all because rubbing ramatroban on your head didn't work? Hm. They're spending millions of dollars to trial setipiprant for hair loss in a "novel approach." I sincerely doubt that this "novel approach" is rubbing a chemical all by itself on your head. I wouldn't call that a treatment, I'd call that rubbing a chemical on your head without any sort of vehicle. 

Also, the issue with bimatoprost in trials had been concentration. In their phase 2b study, they upped the concentration 10X. 0.03% is very weak for hair loss, but it works for eyelashes.

----------


## Energizer

Does anyone have any details on this wounding protocol? Is it a chemical peel? Mechanical? And how many cell layers does it penetrate? I was able to find this but not too much else: http://www.uphs.upenn.edu/news/News_...06/cotsarelis/

----------


## It's2014ComeOnAlready

> The concern for me is does your body compensate by increasing PGD2 further or producing more PGD2 receptors, thus making a permanent treatment more difficult when that comes along.


 Does taking propecia increase DHT or DHT receptors over time? No.

----------


## RGPHILPA

> Theoretically, but people have tried similar treatments that are already available with little to no success. I don't see how setipiprant should be any better than ramatroban. There are a substantial number of people out there who have used that along with various pgf2 analogues, and no miracle results have been reported. I myself just started using ramatroban today along with bimataprost .03%, and will start using D-cloprostenol next week. I'd love to try a higher concentration of bimataprost or latanaprost if I could find a reasonable price on quality powder.


 Laypeople have no clue what they're doing.  They're just grabbing stuff off the shelf and slopping it on their heads and expecting regrowth.  It's not that simple.  Pharmaceutical companies spend significant resources and hire scientist who specialize in formulation development for a reason - it's difficult to get it right.  The dose, the vehicle, frequency of administration etc... all need to be figured out precisely. They have significant effects on exposure, 1/2 life and toxicity. So, it's not surprising that no results were seen.

I wouldn't say this thing is a done deal.  They'll still need to demonstrate efficacy that tops minoxidil and fin to really have a break through product.  I think your average bald dude (i.e. those not on the forums) doesn't think minoxidil and fin will do a thing for them.  My buddy is a  classic example, hes a NW5 who tried minoxidil for a few months.  He saw zero regrowth and gave up on it.  I think a lot of people experience the same thing.   For this treatment to become a big deal, they're gonna have to get impressive results.  Something where, when you go on the drug, you get a very noticeable cosmetic result.  That's really what will bring in the mainstream bald guy who's not familiar with anything that's discussed in these forums.  I'm guessing that this efficacy will need to be 25% or more regrowth with a very high patient response rate.  A homerun, where the treatment becomes a blockbuster, would probably have to approach 50% regrowth.  To me, this is their biggest obstacle; getting a very high efficacy.  It's not been achieved before..  It's fantastic that they already know it's a safe, well tolerated drug; which is the biggest killer of drugs in the clinic.  So we have a good jump on it already.  

I think this is our best shot - it's utilizing the most advanced understanding of MPB that the world has.  Fingers crossed on the proof of concept!

----------


## It's2014ComeOnAlready

> Does anyone have any details on this wounding protocol? Is it a chemical peel? Mechanical? And how many cell layers does it penetrate? I was able to find this but not too much else: http://www.uphs.upenn.edu/news/News_...06/cotsarelis/


 This has nothing to do with wounding. Their trials for follicular neogenesis involved wounding, this is a new treatment to prevent hair loss.

----------


## RGPHILPA

> Does anyone have any details on this wounding protocol? Is it a chemical peel? Mechanical? And how many cell layers does it penetrate? I was able to find this but not too much else: http://www.uphs.upenn.edu/news/News_...06/cotsarelis/


 If you look up follica's patents, they have many different ways of wounding.  I know one of their techniques involved using lasers.  They've put a lot of work into to developing the procedure - quite impressive.  Check them out:
http://www.faqs.org/patents/assignee/follica-inc/

----------


## unbalding

> So, you're doubting that this will work at all because rubbing ramatroban on your head didn't work? Hm. They're spending millions of dollars to trial setipiprant for hair loss in a "novel approach." I sincerely doubt that this "novel approach" is rubbing a chemical all by itself on your head. I wouldn't call that a treatment, I'd call that rubbing a chemical on your head without any sort of vehicle.


 I didn't say it didn't work for me. If you actually understood what you read, you would know that I just started using it today. 

So minoxidil is not a treatment because you rub it on your head? Great logic you have. :Roll Eyes (Sarcastic): 




> Also, the issue with bimatoprost in trials had been concentration. In their phase 2b study, they upped the concentration 10X. 0.03% is very weak for hair loss, but it works for eyelashes.


 Which is exactly why I'd like to try a higher concentration. I'm not paying close to $1,000 though for something that is unproven. Perhaps if we could see the results from the latest trial I could justify it, but not based on rumors of great results. Besides, D-Cloprostenol is similar to bimataprost, only about 50x stronger, but hasn't shown much in the way of results.

----------


## unbalding

> Does taking propecia increase DHT or DHT receptors over time? No.


 That's debatable.

----------


## It's2014ComeOnAlready

> That's debatable.


 Then show us something

----------


## RGPHILPA

> This has nothing to do with wounding. Their trials for follicular neogenesis involved wounding, this is a new treatment to prevent hair loss.


 There is absolutely no basis for this comment.  The Kythera speaker specifically stated that they will be using a novel delivery approach that Upenn has patent protection on.  It could very well be the wounding protocol.  We just don't know at this point.

----------


## It's2014ComeOnAlready

> There is absolutely no basis for this comment.  The Kythera speaker specifically stated that they will be using a novel delivery approach that Upenn has patent protection on.  It could very well be the wounding protocol.  We just don't know at this point.


 No, I do know. A "novel delivery approach" could easily be a topical treatment that Cotsarelis mentioned year after year in his interviews about PGD2. The wounding protocol is distinctly used to create new hairs, not keep or strengthen the ones you already have. Please go read the studies.

----------


## It's2014ComeOnAlready

> I didn't say it didn't work for me. If you actually understood what you read, you would know that I just started using it today. 
> 
> *So minoxidil is not a treatment because you rub it on your head? Great logic you have.*
> 
> 
> 
> Which is exactly why I'd like to try a higher concentration. I'm not paying close to $1,000 though for something that is unproven. Perhaps if we could see the results from the latest trial I could justify it, but not based on rumors of great results. Besides, D-Cloprostenol is similar to bimataprost, only about 50x stronger, but hasn't shown much in the way of results.


 Ok, you don't understand the difference between rubbing a drug on your head by itself and what rogaine does. Rogaine has a vehicle to deliver the drug to the scalp.

Plus you said people have tried similar treatments to setipiprant with little success, and then you mentioned ramatroban as one of those drugs. Learn how to write and use logic, please.

----------


## unbalding

> Then show us something


 



> Increased androgen receptor and remodeling in the prostatic stroma after the inhibition of 5-alpha reductase and aromatase in gerbil ventral prostate.


 http://www.ncbi.nlm.nih.gov/pubmed/19484778

----------


## bigentries

> There is absolutely no basis for this comment.  The Kythera speaker specifically stated that they will be using a novel delivery approach that Upenn has patent protection on.  It could very well be the wounding protocol.  We just don't know at this point.


 Yeah, I don't get where people are claiming this is going to be an oral treatment.

There's big chances the "novel delivery" has something to do with wounding, Cotsareli's has been obsessed with wounding for over a decade.

Probably why Follica seems to be reacting so well to the news

----------


## RGPHILPA

> No, I do know. A "novel delivery approach" could easily be a topical treatment that Cotsarelis mentioned year after year in his interviews about PGD2. The wounding protocol is distinctly used to create new hairs, not keep or strengthen the ones you already have. Please go read the studies.


 I have read the studies.  A topical treatment isn't "novel".  Minoxidil is topical.   

Furthermore, you can find Cotsarelis's presentation at the World Congress for Hair research on Follica's website.  That entire talk is about PGD2.  He even explicitly mentions that a PGD2 antagonist type drug could be therapeutically beneficial.  At the time he gave the presentation and Follica added it to their website, he was already under contract with Kythera.  So, I'm not saying that it's the case for sure, but, there is ample reason to speculate that this very well could end up being used in conjunction with wounding.

----------


## unbalding

> Ok, you don't understand the difference between rubbing a drug on your head by itself and what rogaine does. Rogaine has a vehicle to deliver the drug to the scalp.
> 
> Plus you said people have tried similar treatments to setipiprant with little success, and then you mentioned ramatroban as one of those drugs. Learn how to write and use logic, please.


 Seriously? DMSO doesn't doesn't deliver the drug to the scalp? And yes, ramatroban and setipiprant are both PGD2 inhibitors. Do you not know the meaning of the word similar?

Maybe if you had a reading comprehension beyond a high school level you could actually understand what people are saying.

I don't even know why you're arguing with me. Clearly I believe in this avenue of treatment as well, or I wouldn't be experimenting with it myself.

----------


## RGPHILPA

> Probably why Follica seems to be reacting so well to the news


 
Could you elaborate more?  What do you mean "reacting so well"?

----------


## It's2014ComeOnAlready

> Seriously? DMSO doesn't doesn't deliver the drug to the scalp? And yes, ramatroban and setipiprant are both PGD2 inhibitors. Do you not know the meaning of the word similar?
> 
> *Maybe if you had a reading comprehension beyond a high school level you could actually understand what people are saying*.


 Let me rephrase that sentence so it makes more sense. Maybe if *your* reading comprehension was beyond a high school level, you could communicate more effectively. 

Ugh, you ugly little internet troll.

----------


## bigentries

> Could you elaborate more?  What do you mean "reacting so well"?


 Well, one of the company's founders is backing a rival company and giving the rights to a potential treatment. They are probably involved in some way

----------


## barfacan

If this truly ends up being an oral drug (if it ever even comes out), i sure as **** wont be taking it as i've learned my lesson from Propecia.

----------


## Gerhard

> If this truly ends up being an oral drug (if it ever even comes out), i sure as **** wont be taking it as i've learned my lesson from Propecia.


 Propecia affects your DHT levels. PGD2 inhibition would be an entirely different case. 




> Let me rephrase that sentence so it makes more sense. Maybe if *your* reading comprehension was beyond a high school level, you could communicate more effectively. 
> 
> Ugh, you ugly little internet troll.


 You are rather narrow-minded at times, 2014. All he has done is ask some viable questions about the drug. You don't need to be so utterly defensive about it. If you'd have continued reading his post rather than bolding the aforementioned sentences and reacting defensively towards them you'd have realized that he is as excited and hopeful for this treatment as you.

Try and be more courteous to others. Being bald may be bad, but being rude is simply awful.

----------


## Thinning@30

What I want to know is how does any of this square with Costarelis's bizarre comments to Desmond at last year's hair loss conference in South Korea.  From what I recall, Costarelis was aloof and seemed reluctant to engage or answer any questions, but at the same time was not above pleading for money.

----------


## It's2014ComeOnAlready

> Propecia affects your DHT levels. PGD2 inhibition would be an entirely different case. 
> 
> 
> 
> You are rather narrow-minded at times, 2014. All he has done is ask some viable questions about the drug. You don't need to be so utterly defensive about it. If you'd have continued reading his post rather than bolding the aforementioned sentences and reacting defensively towards them you'd have realized that he is as excited and hopeful for this treatment as you.
> 
> Try and be more courteous to others. Being bald may be bad, but being rude is simply awful.


 People have been hurling insults at me. I've tried to answer questions and express my excitement through facts, and nothing more. I have read everything that has to do with everything about PGD2 and its relation to hair loss. I think most people are uninformed and don't want to accept any of what I'm saying because 1. they're used to bad news. 2. They want to read a fancy news piece, then they'll accept it. 

I'm trying to educate people on why this is the most promising treatment to come, but they want to ask uninformed questions, and not read up on the material themselves. I'm trying to spread positivity, and I'm being told that I don't know how to use logic, or that my reading comprehension is on a high school level.

----------


## barfacan

Can it be formulated as a topical?

----------


## hellouser

> People have been hurling insults at me. I've tried to answer questions and express my excitement through facts, and nothing more. I have read everything that has to do with everything about PGD2 and its relation to hair loss. I think most people are uninformed and don't want to accept any of what I'm saying because 1. they're used to bad news. 2. They want to read a fancy news piece, then they'll accept it. 
> 
> I'm trying to educate people on why this is the most promising treatment to come, but they want to ask uninformed questions, and not read up on the material themselves. I'm trying to spread positivity, and I'm being told that I don't know how to use logic, or that my reading comprehension is on a high school level.


 Who cares dude... you're about to get what looks to be a solid treatment against hair loss. If they keep moaning, it's not going to take away the hair you get back  :Smile:

----------


## HairlossAt15

Hey guys let's not argue anymore, let's only post more news. 




> Can it be formulated as a topical?


 Yes, it 100% can

----------


## RGPHILPA

> Well, one of the company's founders is backing a rival company and giving the rights to a potential treatment. They are probably involved in some way


 Oh, I see what you're saying.  Yes, I agree with you.  It would be quite the conflict of interest for Cotsarelis to go into business with another company going after MPB.   I imagine Puretech ventures would have quite a bit to say about that. Unless of course, they're involved.

----------


## sdsurfin

> Hey guys let's not argue anymore, let's only post more news. 
> 
> 
> 
> Yes, it 100% can


 I feel like the average poster on here is <20 years old and hasn't yet learned how to think or write.  How do you 100% know anything about this? This 2014 dude is killing me, please stop posting. All you do is speak from your hopes and use faulty logic.  Just because a drug can theoretically do something doesn't mean it will.  Ramatroban and cetrizine and OC are all compounds that are incredibly similar to Setipriprant, and none of them have been miraculous for balding. They have all had side effects, some quite serious.  I was only trying to raise these issues before people go and get HTs hoping that this is the cure.  We have no idea if this will come to fruition or whether it will work.  A good example is Actelion's trials for the sea drug on allergies. They were convinced that it would work on allergies for 3 trials before they abandoned it.  You don't know jack shit.  I was pointing out that antihistamines can have really shitty side effects, that being drowsy all day or having a headache all day is not fun, and that I'd love for someone with an IQ higher than a rodent please ask a researcher or go to the clinic in san diego and ask about these things.  It's not that complicated.  And whoever was talking about the placebo effect, yes of course it can play a part, but they use placebos in trials! The side effect profile, which included headaches and drowsiness was incredible much higher than that for the placebo group, and is consistent with what people experience of well known antihistamines.  Ask any dermatologist why people don't love to take zyrtec for years on end. It makes you tired and useless, and if you take it long enough, your body freaks out.  I believe, from past trials, and from similarities in action, that this has the potential to do the same.  Again, I believe it should be looked into before people start putting all their hopes on this being a more realistic drug to take than propecia.  

Secondly, where did they say that they would be using a novel delivery technique? I cnt find that anywhere, and in their shareholders presentation they clearly say it will be an oral drug.

----------


## bigentries

> What I want to know is how does any of this square with Costarelis's bizarre comments to Desmond at last year's hair loss conference in South Korea.  From what I recall, Costarelis was aloof and seemed reluctant to engage or answer any questions, but at the same time was not above pleading for money.


 I find it funny that Costsarelis claimed he needed 20 millions to be "better than propecia", and the announcement claims they will get around 20 millions if they reach milestones.

Costarelis sells himself cheap. Is a potential MPB treatment just worth 20 millions? I don't know how good their royalties would be if it gets commercialised

----------


## It's2014ComeOnAlready

> I have read the studies.  *A topical treatment isn't "novel".*  Minoxidil is topical.   
> 
> Furthermore, you can find Cotsarelis's presentation at the World Congress for Hair research on Follica's website.  That entire talk is about PGD2.  He even explicitly mentions that a PGD2 antagonist type drug could be therapeutically beneficial.  At the time he gave the presentation and Follica added it to their website, he was already under contract with Kythera.  So, I'm not saying that it's the case for sure, but, there is ample reason to speculate that this very well could end up being used in conjunction with wounding.


 A topical treatment would be novel. Name a hair loss treatment that stops you from losing hair on every part of the scalp, that works topically. 

Minoxidil only works on the crown, if it works at all.

----------


## It's2014ComeOnAlready

> *I feel like the average poster on here is <20 years old and hasn't yet learned how to think or write.*  How do you 100% know anything about this? *This 2014 dude is killing me, please stop posting. All you do is speak from your hopes and use faulty logic.*  Just because a drug can theoretically do something doesn't mean it will.  Ramatroban and cetrizine and OC are all compounds that are incredibly similar to Setipriprant, and none of them have been miraculous for balding. They have all had side effects, some quite serious.  I was only trying to raise these issues before people go and get HTs hoping that this is the cure.  We have no idea if this will come to fruition or whether it will work.  A good example is Actelion's trials for the sea drug on allergies. They were convinced that it would work on allergies for 3 trials before they abandoned it.  *You don't know jack shit*.  I was pointing out that antihistamines can have really shitty side effects, that being drowsy all day or having a headache all day is not fun, and that *I'd love for someone with an IQ higher than a rodent* please ask a researcher or go to the clinic in san diego and ask about these things.  It's not that complicated.  And whoever was talking about the placebo effect, yes of course it can play a part, but they use placebos in trials! The side effect profile, which included headaches and drowsiness was incredible much higher than that for the placebo group, and is consistent with what people experience of well known antihistamines.  Ask any dermatologist why people don't love to take zyrtec for years on end. It makes you tired and useless, and if you take it long enough, your body freaks out.  I believe, from past trials, and from similarities in action, that this has the potential to do the same.  Again, I believe it should be looked into before people start putting all their hopes on this being a more realistic drug to take than propecia.  
> 
> Secondly, where did they say that they would be using a novel delivery technique? I cnt find that anywhere, and in their shareholders presentation they clearly say it will be an oral drug.


 You're clearly the one without maturity, use of logic, and find it appropriate to hurl insults. Anyone who reads the material on PGD2 and then reads my comments will find that there's nothing I'm saying that's out-of-bounds.

----------


## sdsurfin

> A topical treatment would be novel. Name a hair loss treatment that stops you from losing hair on every part of the scalp, that works topically. 
> 
> Minoxidil only works on the crown, if it works at all.


 No one ever said this will be a topical treatment.  Their shareholder presentation states very clearly that they are using this as an oral drug.  We don't even know if trans-epidermal delivery is possible with this molecule.  It is also a drug that, even if used topically, does not disintegrate before it hits the bloodstream, meaning it will have the same sides.  

People are having the same reaction to this as for the drug that is being tested for areata. sure, they might work, but a huge number of people might not be able to use it.  Also, compounds that are very similar to this have been trialled by people online with not much success.  Even people like cotsarellis are not aware of those results to some degree. Dr. Xu emailed me a few months back asking if people had had success with ramatroban.  This drug may be quite good for prevention, but that's no blockbuster. In combination with something like BIM it might be really good, but BIM is another drug that has crap side effects so far.  Id rather be bald than have swollen ****ed up eyes, a constant headache, and feel sleepy and fart all the time.  Hopefully these sides will not occur or they will figure out a dosage that works to reduce them, I'm just saying don't get all too hyped up just yet.  When a cell based treatment comes to fruition then I'll be excited.

----------


## hellouser

> I find it funny that Costsarelis claimed he needed 20 millions to be "better than propecia", and the announcement claims they will get around 20 millions if they reach milestones.
> 
> Costarelis sells himself cheap. Is a potential MPB treatment just worth 20 millions? I don't know how good their royalties would be if it gets commercialised


 No, the 20 million remark was in regards to a full cure. Therefor, a cure already exists.

----------


## It's2014ComeOnAlready

It's been posted, but I'll repost. Here's an audio recording from people at Kythera discussing this drug for hair loss: 

https://clyp.it/41mcx0mb

----------


## hellouser

> We don't even know if trans-epidermal delivery is possible with this molecule.


 It's molecular weight is only 402 dalton, it'll pass through skin quite easily.

----------


## It's2014ComeOnAlready

Here's the patent kythera purchased the rights to. It states the the application will be topical, although no mention has been made about the delivery, besides this.

https://www.google.com/patents/WO2013142295A1?cl=en

----------


## noisette

I don't know if you have ever seen this doc, so I share : http://files.shareholder.com/downloa...5BFA2E/KYTHERA 


Page 6 and next

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## hellouser

> Here's the patent kythera purchased the rights to. It states the the application will be topical, although no mention has been made about the delivery, besides this.
> 
> https://www.google.com/patents/WO2013142295A1?cl=en


 There's no mention of Kythera in that patent....

----------


## Energizer

> If you look up follica's patents, they have many different ways of wounding.  I know one of their techniques involved using lasers.  They've put a lot of work into to developing the procedure - quite impressive.  Check them out:
> http://www.faqs.org/patents/assignee/follica-inc/


 Thank you my friend. I will look at these. 

I asked because earlier in this very long thread I read that the preventative treatment may be released in conjunction with bimatoprost and a wounding protocol for regrowth. I don't know if that was correct or not. I'm on a slow connection so it would take about five minutes to page back. 

I have abnormal scarring so I would like to know if wounding would due more harm than good to me, were it ever to become viable. 

We need a collection of all the available primary documents surrounding these new treatments so folks can look through them all in one place. I see people referencing "the articles" but they are linked sporadically. Maybe I'll collect them up.

----------


## Justinian

Does anyone know why they are so vague when talking about the novel delivery method? It's patent protected right?

----------


## HairlossAt15

> How do you 100% know anything about this?


 I know that it can be converted into a topical 100%, because they have already (for the last 2 years) been testing 5 different GPR44 Blockers (one of which is Setipriprant) on explanted human hairs. Obviously a pill cannot be digested by a hair follicle.




> and in their shareholders presentation they clearly say it will be an oral drug


 Again, you are misrepresenting the truth, they said it would be "Oral dosing	(improved	compliance)" i.e people will find it easier to take the drug orally, leading to more sales etc. If it is just as effective orally as it is topically, then why not? If not, I wouldn't mind a topical formulation. The point is, both are possible.

For anyone interested, a couple of years ago I created a thread with all the information I could find and my opinion. 

https://www.baldtruthtalk.com/showth...sis&highlight=

Yes, this is all just basic science, and noone is saying it is a cure. There a no major side effects, headaches drowsiness etc are "side-effects" seen in almost every trial and some people think that something as trivial as a vitamin pill can give you those side effects...

The positives far way out the negatives, by leaps and bounds.

----------


## sdsurfin

I only mention these side effects because the percentages were very high, the incidence of such effects is very high with other antihistamines, and there is a withdrawal effect from these drugs that is not talked about even by many doctors.  There are always low percentages of people that report headaches and drowsiness, but not at these percentages.  If that's too hard to understand I don't know how else to say it.  Talk to anyone who has taken zyrtec.  I too hope that the side effects will be outweighed by the positives. Just don't get your hopes too high. 

Also, Kythera purchased cotsarellis' patents, but that doesn't mean they will follow those patents. From their shareholders presentation its pretty obvious they plan to develop and test this as a pill.  Is it possible to make it a topical? who knows, probably.  Either way the side effect shouldn't vary much.

----------


## It's2014ComeOnAlready

> *Also, Kythera purchased cotsarellis' patents, but that doesn't mean they will follow those patents. From their shareholders presentation its pretty obvious they plan to develop and test this as a pill.*  Is it possible to make it a topical? who knows, probably.  Either way the side effect shouldn't vary much.


 No, the "novel" delivery method is part of the patent, which is what they purchased. It's not so obvious they will test this in pill form because they already have done that in healthy male and female patients.

----------


## sdsurfin

> It's been posted, but I'll repost. Here's an audio recording from people at Kythera discussing this drug for hair loss: 
> 
> https://clyp.it/41mcx0mb


 This audio said nothing about delivery method. "the novel method of use" bought by kythera and provided by Upenn simply means the act of using setipriprant as a hair growth molecule.  The molecule itself is being bought from actelion.  Again, you are misunderstanding what people say and reading into things.  

This is no big deal yet, they have no idea how it will work in vivo. Ramatroban keeps hair growing in vitro as well.  Hopefully it wrks, but certainly no guarantees. Propecia maintains hair and grows a good amount in many people, so there's no way this gets released if it isn't as good, and other PGD2 receptor blockers have not panned out very well in unofficial trials.

----------


## Justinian

> I only mention these side effects because the percentages were very high, the incidence of such effects is very high with other antihistamines, and there is a withdrawal effect from these drugs that is not talked about even by many doctors.  There are always low percentages of people that report headaches and drowsiness, but not at these percentages.  If that's too hard to understand I don't know how else to say it.  Talk to anyone who has taken zyrtec.  I too hope that the side effects will be outweighed by the positives. Just don't get your hopes too high. 
> 
> Also, Kythera purchased cotsarellis' patents, but that doesn't mean they will follow those patents. From their shareholders presentation its pretty obvious they plan to develop and test this as a pill.  Is it possible to make it a topical? who knows, probably.  Either way the side effect shouldn't vary much.


 The side effects you're referring to were from a sample size of 20, so 2 people getting a fairly common human feeling = 10%. There was no placebo to compare to. Here is the excerpt from the study at http://www.ncbi.nlm.nih.gov/pubmed/24095247

"Setipiprant was well tolerated at the tested dose, with no apparent effects on clinical laboratory variables, vital signs, weight, ECG variables, or ECG morphology. In total, 10 of 20 subjects reported at least one adverse event (AE) during the study. Headache was the most frequently reported AE (in 25% of subjects), followed by flatulence (15%) and somnolence and fatigue (10%). Only 1 case of headache, 1 case of somnolence, and 2 cases of fatigue were judged to be related to study drug by the investigator.

No AEs of severe intensity and no serious AEs were reported during the study. One case of moderate headache (1 man, treatment A) and 2 cases of moderate fatigue (2 women, treatment B) were reported; all other AEs were rated to be of mild intensity by the investigator. All AEs resolved without sequelae. The AE incidence in men and women and between treatments was similar."

----------


## sdsurfin

Cool. Thanks for elucidating.  I get bad sides from everything, and when I take zyrtec or claritin I get mild headaches and sometimes bad drowsiness.  Might expect similar from this drug, a lot will probably tolerate it better, and some worse.  I'm still most concerned about the withdrawal possibility after years of use, and would love to be able to talk to an expert about it. Sucks that kythera has no email.

----------


## It's2014ComeOnAlready

> This audio said nothing about delivery method. *"the novel method of use"*.


 That's correct, and I wasn't trying to further my point by making that post. Just trying to share information in a helpful way. Anyway, they bought all the patents, which say topical. Who knows how they are going to administer it. I only doubt that it's oral, because they already tested it orally in healthy men and women. 

Yes, also other PGD2 inhibitors have the same effect, but they chose this drug because of "specificity and safety."

----------


## sdsurfin

In any case, it will be interesting to see.

If replicel comes out with their product anytime near when these guys do, and replicel works, it's gonna be a much better option.

----------


## Sogeking

> In any case, it will be interesting to see.
> 
> If replicel comes out with their product anytime near when these guys do, and replicel works, it's gonna be a much better option.


 Why is everyone on this forum so stuck on exclusive usage of treatments. I mean if Replicel and Setipripant both come out, you could use both of them.

That is the point of all the new possible treatments coming out (CB, Sm, Septipripant, Replicel, Histogen and even Pilofocus).

Replicel has the best safety profile. However I am betting that Histogen has the best effectivity.

In the end the more of them come out, more options we hive. I'm sure there will be people using all of them at once.

----------


## hellouser

> Why is everyone on this forum so stuck on exclusive usage of treatments. I mean if Replicel and Setipripant both come out, you could use both of them.
> 
> That is the point of all the new possible treatments coming out (CB, Sm, Septipripant, Replicel, Histogen and even Pilofocus).
> 
> Replicel has the best safety profile. However I am betting that Histogen has the best effectivity.
> 
> In the end the more of them come out, more options we hive. I'm sure there will be people using all of them at once.


 I'll be signing up for any and ALL non-hormone altering options.... so, yeah; Minox + Histogen + Replicel + Setipripant + BIM + CB + RU. At that point, I'd expect serious results.

----------


## woodnor

Hey guys, maybe someone can help me understand this  :Smile: :

Why is it that nobody had trialed setipiprant _for hairloss_ before if Cotsarelis made the discovery of PGD2 and hairloss in 2011? Is it because they needed funding?

Also, was Cotsarelis involved in Kythera getting the funding for the trials?

----------


## hellouser

> Hey guys, maybe someone can help me understand this :
> 
> Why is it that nobody had trialed setipiprant _for hairloss_ before if Cotsarelis made the discovery of PGD2 and hairloss in 2011? Is it because they needed funding?
> 
> Also, was Cotsarelis involved in Kythera getting the funding for the trials?


 Because there's no way of getting it and the only PGD2 inhibitors that were ever tried were CETIRIZINE and 'OC' neither of which were proper.

----------


## RGPHILPA

> Here's the patent kythera purchased the rights to. It states the the application will be topical, although no mention has been made about the delivery, besides this.
> 
> https://www.google.com/patents/WO2013142295A1?cl=en


 Thanks for posting.  I didn't see that this was the patent they acquired.    The "novel" approach mentioned appears to be in regards to going after PGD2/GPR44 for treating hairloss rather than the actual delivery of the drug.  So, most likely you're correct. But....and this a big kim kardashian sized butt..... i would like to direct your attention to one particular part of the patent which i think is interesting and could be referring to the wounding protocol from Follica:

[0081] Other therapeutically effective agents / treatments for a *combination therapy to enhance hair growth include, for example, but not limited to, transplantation surgery and removing dermis or epidermis*. Other therapeutically effective agents / treatments include for a combination therapy to inhibit hair growth include, for example, but not limited to, removing hair on skin by mechanical or chemical methods known to one of skilled in the art.

So, this patent is basically wide open and covers a lot ground.  So, it's tough to figure out where they're going with it.  But, what they've written in section 81 is pretty much a play by play from Follica's initial business plan.  They had mentioned using their technique for both hair growth and removal.  And here we come across it again.  The mention of combination type therapy makes me think that they definitely could be involved here.   However,  you may very well be right and this will be a more straight up topical, medication only type of approach.

None the less, very, very exciting news.

----------


## It's2014ComeOnAlready

Can anyone with knowledge of how clinical trials work tell us how many trials they will have to do for this? They have done a lot of work in regards to safety and dosing, would that mean all they have left is efficacy? 

Their CEO also mentioned a proof-of-concept would cost them $10 million. That sounds like a lot for one trial, maybe it's a trial to determine efficacy in a large population?

----------


## hellouser

> Can anyone with knowledge of how clinical trials work tell us how many trials they will have to do for this? They have done a lot of work in regards to safety and dosing, would that mean all they have left is efficacy? 
> 
> Their CEO also mentioned a proof-of-concept would cost them $10 million. That sounds like a lot for one trial, maybe it's a trial to determine efficacy in a large population?


 Phase 2A, 2B and 3.

Then it requires a FINAL approval from the FDA before going commercial. In reality, they've only skipped Phase 1 because its already been tested for safety.

----------


## sdsurfin

They are starting with IIb, I'm not positive whether this counts as their proof of concept or if there is a POC and then a 2b. 
they would still have to do a phase 3, and then get it approved.  Basically they have to show efficacy and proof that it makes sense, and then phase 3 is to really nail it down in a large group of patients.  Hopefully it goes better than their asthma trials.

----------


## HairlossAt15

They said phase 2b in the Web cast. But they already have a team and lab setup so it shouldn't take as long, also on their website it says they have 100 million(entire company)  available and this trial will only take around 10 million. 

So it shouldn't take to long, once phase 2b is finished they will have data on how much hair growth patients got from the treatment(since phase 2b is on human patients) 

In other words it won't be long until we have some real idea about how good this will be.

----------


## Sogeking

> They are starting with IIb, I'm not positive whether this counts as their proof of concept or if there is a POC and then a 2b. 
> they would still have to do a phase 3, and then get it approved.  Basically they have to show efficacy and proof that it makes sense, and then phase 3 is to really nail it down in a large group of patients.  Hopefully it goes better than their asthma trials.


 How can you be sure that it is Phase2b? Although if it is, then it could be out on the market in 5 years.

Granted the sum of 10mil mentioned before does usually pertain to Phase 2 and higher...

@HairlossAt15
Well in that case that is really fast possible approval process.

----------


## Bald Russian

Can i add my 2 cents? Another 5 year...
Already any new story is so ironic bad joke. Already dont belive that anything will be good. I tired to use some chemicals on my head, skin hurts... I gonna shave head and forget about hair, sad but true.

----------


## woodnor

> Because there's no way of getting it and the only PGD2 inhibitors that were ever tried were CETIRIZINE and 'OC' neither of which were proper.


 What did you mean by "there's no way of getting it"? Did you mean that there was no way of getting setipiprant before? (If you meant that), wasn't setipripant being trialed already for something else before? (sorry I don't really understand how all the protocols work)

----------


## It's2014ComeOnAlready

> Phase 2A, 2B and 3.
> 
> Then it requires a FINAL approval from the FDA before going commercial. In reality, they've only skipped Phase 1 because its already been tested for safety.


 I see. However, their CEO mentions they're done with dosing as well. The only thing they would really need to prove is efficacy with a large enough group. They only mention the POC in their future development plans with this drug. I seriously wonder if all they need is one trial then approval.

----------


## sdsurfin

> I see. However, their CEO mentions they're done with dosing as well. The only thing they would really need to prove is efficacy with a large enough group. They only mention the POC in their future development plans with this drug. I seriously wonder if all they need is one trial then approval.


 They are at phase 2b.  that means they need to do two trials. first they have to file for an IND and proof of concept.  So really it would be about 4 years minimum.  1 yr POC, 1 yr 2b, 1 yr phase 3(if they do one, maybe they don't need it?) and one year min to file for approval.  

It really blows that we have to wait around 4 or 5 years for anything of substance, I think this time the 5 year wait is actually realistic, but gotta find a way to maintain until then. If we're incredibly lucky we might have replicel in japan or SM or Bim here in three years.  

Is anyone on RU and maintaining? I can't take fin or minox, and I'm trying cetrizine but i feel tired and throaty all the time on it.  I do think replicel will be solid, but I gotta hold on until then.

----------


## It's2014ComeOnAlready

Gah I hope it's not 5 years. I don't see why they couldn't establish efficacy in a POC, then jump to phase 3, meanwhile filing NDA approval during phase 3 to speed up the process. It's a drug that has been studied in 8 trials, what else would you need to know other than that it works?

I think you guys are going by what the standard is for clinical trials (and I get that). I think this case may be different due to how studied it is, that it has had a phase 3 etc. 

I might try and contact them to see if they could answer this.

----------


## HairlossAt15

Just re-listened to webcast, he said phase 2a POC trial, but I cant imagine it will take that long and it will still be done on human patients, meaning we will have data within a few months hopefully.

----------


## sdsurfin

you should contact them. normal clinical trials usually take between 7-15 years.  So 5 years isn't bad really in the grand scheme of things.  The POC will prob be the only trial before phase 3, but it might take a year just to file for and plan that trial, if not longer. these things take time.  

In more positive news, these guys  http://www.pulmagen.com/adc3680.html

and also the guys developing OC045 are both developing antagonists of the same receptor, and are already done with phase 2b trials.  We could see one of those come out soon, and they are probably very very similar. Kythera could not have purchased the rights to those because they are already licensed and in development for other things, but i doubt they are too different.  

I know its easy to get down about this, but basically we are in the transition phase between the propecia generation, which was ****ed, and a new generation of treatments.  We're lucky to be on the brink of these things, and not in the days of our grandfathers, when there was nothing.  I am a huge skeptic and not generally optimistic about progress in medicine, but I truly do think we will have several better options in 5 years, 8 or ten at the most.  If replicel pans out then we can pretty much kiss this thing goodbye, which is really saying a lot.  

In the meantime don't spend your time on this stuff, I'm trying to figure out if there's a viable maintenance option right now, just got some RU and might try topical fin, and if nothing works then I'll just ride it out.  Shiseido makes a topical called Adenogen, which I can't attest to the efficacy of yet, but it has not given me any sides, and i get sides from even minox.  I know a lot of people who kept their hair for 3 or 4 years just on minoxidil, so just do what you can, don't stress, and I think better days are coming. If you're already noticeably bald then I suggest you just buzz it down and love yourself, don't be like the psychos on here that proclaim it's a death sentence or that people hate bald guys.  Ive been around and that has not been my experience in the least. The women on my moms side of the family were all gorgeous, and all married bald men, and the women on my dads side were not gorgeous and married full haired men.  Good indication of how much it matters to others.  If you love yourself others will love you.  It's a strugge for everyone, and no one is 100 percent satisfied with life.  If they are they are just waiting for a struggle to happen.  My best looking most full haired friend just lost his mom to alzheimers at a pretty early age, so imagine what he has to worry about.  Life's a bitch for everyone, so just be positive and know that hair means almost nothing.  I'm out for now.

----------


## sdsurfin

Also I've been looking into antihistamine side effects more, and I think my prior fears were probably a bit overblown.  Cetirizine blocks a very different receptor than setipiprant, and even in the case of cetirizine withdrawal, it was usually after many years, and people were able to get through it by reducing dosage over a few weeks.  Definitely nothing as scary as propecia.  I'm sure Pip will have side effects, but probably none that are horrible, and most people should probably be fine on it.  What worries me most is the drowsiness, but we can only speculate as to how bad that will be. hopefully not bad.

----------


## sdsurfin

As a reference, it took merck 5 years to approve propecia for MPB once it was already approved for the prostate.  Setipiprant has not been approved for anything yet.  So you can estimate how long this might take from those numbers unless there's some other caveats that i'm not aware of.  OC045 is in phase three trials I think, so we might be able to use that sooner off label.

----------


## NeedHairASAP

> As a reference, it took merck 5 years to approve propecia for MPB once it was already approved for the prostate.  Setipiprant has not been approved for anything yet.  So you can estimate how long this might take from those numbers unless there's some other caveats that i'm not aware of.  OC045 is in phase three trials I think, so we might be able to use that sooner off label.


 
As a reference to your reference, email didn't even exist then. Things move faster and faster everyday.

----------


## oppenheimer82

> you should contact them. normal clinical trials usually take between 7-15 years.  So 5 years isn't bad really in the grand scheme of things.  The POC will prob be the only trial before phase 3, but it might take a year just to file for and plan that trial, if not longer. these things take time.  
> 
> In more positive news, these guys  http://www.pulmagen.com/adc3680.html
> 
> and also the guys developing OC045 are both developing antagonists of the same receptor, and are already done with phase 2b trials.  We could see one of those come out soon, and they are probably very very similar. Kythera could not have purchased the rights to those because they are already licensed and in development for other things, but i doubt they are too different.  
> 
> I know its easy to get down about this, but basically we are in the transition phase between the propecia generation, which was ****ed, and a new generation of treatments.  We're lucky to be on the brink of these things, and not in the days of our grandfathers, when there was nothing.  I am a huge skeptic and not generally optimistic about progress in medicine, but I truly do think we will have several better options in 5 years, 8 or ten at the most.  If replicel pans out then we can pretty much kiss this thing goodbye, which is really saying a lot.  
> 
> In the meantime don't spend your time on this stuff, I'm trying to figure out if there's a viable maintenance option right now, just got some RU and might try topical fin, and if nothing works then I'll just ride it out.  Shiseido makes a topical called Adenogen, which I can't attest to the efficacy of yet, but it has not given me any sides, and i get sides from even minox.  I know a lot of people who kept their hair for 3 or 4 years just on minoxidil, so just do what you can, don't stress, and I think better days are coming. If you're already noticeably bald then I suggest you just buzz it down and love yourself, don't be like the psychos on here that proclaim it's a death sentence or that people hate bald guys.  Ive been around and that has not been my experience in the least. The women on my moms side of the family were all gorgeous, and all married bald men, and the women on my dads side were not gorgeous and married full haired men.  Good indication of how much it matters to others.  If you love yourself others will love you.  It's a strugge for everyone, and no one is 100 percent satisfied with life.  If they are they are just waiting for a struggle to happen.  My best looking most full haired friend just lost his mom to alzheimers at a pretty early age, so imagine what he has to worry about.  Life's a bitch for everyone, so just be positive and know that hair means almost nothing.  I'm out for now.


 we all know your opinion now. could you stop trolling please?

----------


## ledhead

I was under the impression cet lowered pgd2 levels as a whole opposed to blocking receptor sites






> Also I've been looking into antihistamine side effects more, and I think my prior fears were probably a bit overblown.  Cetirizine blocks a very different receptor than setipiprant, and even in the case of cetirizine withdrawal, it was usually after many years, and people were able to get through it by reducing dosage over a few weeks.  Definitely nothing as scary as propecia.  I'm sure Pip will have side effects, but probably none that are horrible, and most people should probably be fine on it.  What worries me most is the drowsiness, but we can only speculate as to how bad that will be. hopefully not bad.

----------


## sdsurfin

> I was under the impression cet lowered pgd2 levels as a whole opposed to blocking receptor sites


 It blocks the h1 receptor. Not sure if they know how it lowers pgd2.

----------


## sdsurfin

I'm not sure clinical trials move any faster now than they used to. Pretty sure they don't. The science does for sure.

----------


## It's2014ComeOnAlready

I'm putting my estimation at 2 years. POC to establish efficacy, then a phase 3 with a larger group. An NDA can be filed during the duration of phase 3, shortening the entire process. 

When they tested this drug for asthma, they did a POC and then a phase 3. 

to quote Cotsarelis: "Companies in general try to keep the number of trials to the minimum. The more trials you do, the greater the chances for an adverse effect to be found."

----------


## It's2014ComeOnAlready

> I'm not sure clinical trials move any faster now than they used to. Pretty sure they don't. The science does for sure.


 I read an article recently in nature medicine that states by having an electronic filing system or database, clinical trials can be moved along a lot faster. Email, in this case would be helpful.

----------


## burtandernie

> I read an article recently in nature medicine that states by having an electronic filing system or database, clinical trials can be moved along a lot faster. Email, in this case would be helpful.


 How do you not have an electronic filing system or database in this age? I hope the FDA doesnt move at turtle pace for anything having to do with this.

----------


## It's2014ComeOnAlready

> *How do you not have an electronic filing system or database in this age*? I hope the FDA doesnt move at turtle pace for anything having to do with this.


 The red tape of bureaucracy.

----------


## It's2014ComeOnAlready

I've read another article that speaks about drug repurposing. It says: The amount of time saved will depend on the amount of data publicly available on the compound, the stage of its development, and the length of trials required for the specific therapeutic target selected, as well as the amount of formulation required, particularly if this involves a change in route of administration. “At a minimum, a strong phase 2 proof-of-concept study can lead directly to phase 3 trials and commercialization in a few years, though in practice there is almost always additional information required, particularly if there is a change in the dosing and administration or if the MOA [mechanism of action] for the new indication is not well characterized,” says Flostrand.

Data publicly available: 7 studies, 8 clinical trials
Stage of Development: Has gotten through phase 3
Length of trial required for specific therapeutic target: hair cycling takes a while, but within the bounds of the length of a clinical trial
Dosing: already complete
Mechanism of action: has been established in earlier trials and studies
Administration: the only real issue. May be administered topically, but if it is successful in POC, there should be no issue.

----------


## HairlossAt15

I'm sure once everything  settles down they will release some more info, maybe they will give a timeline this week.

----------


## Scientalk56

whats so special about " Kythera"? is that another five-forever years treatment?

----------


## walrus

> whats so special about " Kythera"? is that another five-forever years treatment?


 Perhaps, but the difference is that this actually has a sound scientific background in support.

----------


## NeedHairASAP

> whats so special about " Kythera"? is that another five-forever years treatment?


 
The company is worth $1B company-- so they have money and a good track record

----------


## Scientalk56

lol... Most treatments with scientififc background is five-forever treatments... so i guess its another bullshit..

i have been following this forum since 2009 - MORE THAN FIVE YEARS.. and no five-years treatment has ever came to market. 
only Propecia and Minoxidil getting new designs.. lol

----------


## walrus

> lol... Most treatments with scientififc background is five-forever treatments... so i guess its another bullshit..
> 
> i have been following this forum since 2009 - MORE THAN FIVE YEARS.. and no five-years treatment has ever came to market. 
> only Propecia and Minoxidil getting new designs.. lol


 Do you think science is bullshit then? ... lol

----------


## Scientalk56

> Do you think science is bullshit then? ... lol


 No, its just 20 years far..in best case scenario.. those are great news for my grandchildren. 

We need "finally a treatment got a fda apporval for treating baldness" news.. which we wont see.. 

Back to minixidil and propecia..

----------


## PatientlyWaiting

> lol... Most treatments with scientififc background is five-forever treatments... so i guess its another bullshit..
> 
> i have been following this forum since 2009 - MORE THAN FIVE YEARS.. and no five-years treatment has ever came to market. 
> only Propecia and Minoxidil getting new designs.. lol


 It's true, nothing ever comes out. Everything is always 5 years away.

I will graduate college, get a master's degree, get a PhD, have a wife, kids, and the kids will grow up and have kids. And still, i'll come back to TBT 2-3 times a year and read about the next big treatment that is finally coming after Propecia/Rogaine. Which will be a drug that works like finasteride with no side effects...lol. Meanwhile, all the mice in the world are growing hair by just mixing water with Kool-aid powder and adding some chopped up onions in it. Because you know, everything grows hair on mice.

----------


## LongWayHome

> It's true, nothing ever comes out. Everything is always 5 years away.
> 
> I will graduate college, get a master's degree, get a PhD, have a wife, kids, and the kids will grow up and have kids. And still, i'll come back to TBT 2-3 times a year and read about the next big treatment that is finally coming after Propecia/Rogaine. Which will be a drug that works like finasteride with no side effects...lol. Meanwhile, all the mice in the world are growing hair by just mixing water with Kool-aid powder and adding some chopped up onions in it. Because you know, everything grows hair on mice.


 OMG man that was good! I actually laughed.
"...All the mice in the world are growing hair by just mixing water with Kool-aid powder..."
That's gold jerry! Gold!

Sad, but true.

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## sdsurfin

You've been on here 5 years. wow. that is nothing. Your logic is flawed.  Just because nothing has happened in those 5 years doesn't mean it won't. People were saint the same thing as you in the 90s, and then boom, propecia came out.  it is effective, but not perfect. the next drug will also be effective, and maybe a bit more perfect.  They have learned a lot about mpb in the last 5, and are now applying that knowledge. There are about 6 new treatments for AGA in the pipeline, as opposed to basically none 5 years ago.  Intercytex and aderans failed because the science was not there yet, and their failure is a step along the way to a really huge stem cell fix that is still a bit off. I think you're quite wrong about not having anything else in five years though.  Things do happen, just not according to our personal plans.  They cured hepatitis C out of nowhere, as well as alopecia areata. You never know when something will work, and some things in trials now have a lot of promise.  Your speculation that nothing is coming is no more accurate than saying "5 years".  There is pretty much zero chance that nothing else will come in the next 20 years, that is just nonsense. I'm already using Adenogen from shiseido and it has equal efficacy to minox with no sides, so you're already wrong that there is nothing new.  I would say that as soon as 3 years we could have a new maintenance treatment, and within 20 there will definitely be cell based therapies.  If you educated yourself on the science, that becomes very clear.

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## Hairismylife

> You've been on here 5 years. wow. that is nothing. Your logic is flawed.  Just because nothing has happened in those 5 years doesn't mean it won't. People were saint the same thing as you in the 90s, and then boom, propecia came out.  it is effective, but not perfect. the next drug will also be effective, and maybe a bit more perfect.  They have learned a lot about mpb in the last 5, and are now applying that knowledge. There are about 6 new treatments for AGA in the pipeline, as opposed to basically none 5 years ago.  Intercytex and aderans failed because the science was not there yet, and their failure is a step along the way to a really huge stem cell fix that is still a bit off. I think you're quite wrong about not having anything else in five years though.  Things do happen, just not according to our personal plans.  They cured hepatitis C out of nowhere, as well as alopecia areata. You never know when something will work, and some things in trials now have a lot of promise.  Your speculation that nothing is coming is no more accurate than saying "5 years".  There is pretty much zero chance that nothing else will come in the next 20 years, that is just nonsense. I'm already using Adenogen from shiseido and it has equal efficacy to minox with no sides, so you're already wrong that there is nothing new.  I would say that as soon as 3 years we could have a new maintenance treatment, and within 20 there will definitely be cell based therapies.  If you educated yourself on the science, that becomes very clear.


 How much regrowth from Adenogen?

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## StayThick

> You've been on here 5 years. wow. that is nothing. Your logic is flawed.  Just because nothing has happened in those 5 years doesn't mean it won't. People were saint the same thing as you in the 90s, and then boom, propecia came out.  it is effective, but not perfect. the next drug will also be effective, and maybe a bit more perfect.  They have learned a lot about mpb in the last 5, and are now applying that knowledge. There are about 6 new treatments for AGA in the pipeline, as opposed to basically none 5 years ago.  Intercytex and aderans failed because the science was not there yet, and their failure is a step along the way to a really huge stem cell fix that is still a bit off. I think you're quite wrong about not having anything else in five years though.  Things do happen, just not according to our personal plans.  They cured hepatitis C out of nowhere, as well as alopecia areata. You never know when something will work, and some things in trials now have a lot of promise.  Your speculation that nothing is coming is no more accurate than saying "5 years".  There is pretty much zero chance that nothing else will come in the next 20 years, that is just nonsense. I'm already using Adenogen from shiseido and it has equal efficacy to minox with no sides, so you're already wrong that there is nothing new.  I would say that as soon as 3 years we could have a new maintenance treatment, and within 20 there will definitely be cell based therapies.  If you educated yourself on the science, that becomes very clear.


 Until something if/eventually hits the market then your opinion is just that..your opinion. Nothing short of minox and fin is what we have available back then and now period.

Personally, I've seen countless threads since I've been a member here of all sorts of "potential" breakthroughs, pipeline, claims, etc. Guess what? Not one has ever been released or close to being released. Not one. 

I won't hold my breath for this or anything short of improvements to the hair transplant industry. That is and will remain the only viable option to get permanently bye bye hair back on your scalp even if for a limited time. 

Really don't care what you believe will potentially come out either because you just join the plenty that have created hope for those desperate on this forum for anything, anything to show promise, only to still be stuck with a penis wrecking pill and a foam that ages skin.

I wish you the best.

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## kmit028

well look at RU, it is really big now and readily available, and thats all a result of forums like this. So really that is what we can try and do with SET, or other such experimental treatments.

BTW, those negative posters like PatientlyWaiting, LongWayHome, StayThick, Hairismylife, why are you even in the experimental forum??? All you guys do is cry about hairloss. But never try to think outside the box and try to come up with a solution or alternative. Stop focusing on the problem and focus on a solution.

sdsurfin, good on you for trying to find a solution. Maybe it will work, prob wont, but at least we are trying something instead of just crying like babies and trying to disprove every far fetched idea

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## sdsurfin

> How much regrowth from Adenogen?


 Having been using it long enough to know, and my hair isn't too bad, so it's hard to tell.
Topical cetirizine has completely stopped my mpb itch, but it dries my whole mouth and throat out. 
We mell well be ****ed with nothing new on the horizon, but the opposite could be true as well.  The PGD2 pathway is definitely real, and definitely has the potential to halt hair loss. I agree nothing is going to grow hair on bald scalp, but maintaining what you have is already possible with propecia, and will be possible with better alternatives soon I think.  No one knew anything about hair loss ten years ago. they now at least know  the basic pathways downstream of DHT activation, and that knowledge is bound to lead somewhere.  I don't remember any new drugs being trialled for MPB in the near-past except RU, which actually does work to some extent and is being used by many despite lack of approval.  Cell based treatments have failed so far because they weren't quite there with their knowledge.  

I'm pretty sure that anyone who can handle cetirizine (and most people can use zyrtec without major sides) or can afford ramatroban already has a better alternative to minoxidil.

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## kaptainjack

I might just give cetirizine a try orally. It's available over the counter and costs next to nothing. Where I live they sell it in liquid form as well, and I wonder if it would be worth trying out topically.

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## StayThick

> Having been using it long enough to know, and my hair isn't too bad, so it's hard to tell.
> Topical cetirizine has completely stopped my mpb itch, but it dries my whole mouth and throat out. 
> We mell well be ****ed with nothing new on the horizon, but the opposite could be true as well.  The PGD2 pathway is definitely real, and definitely has the potential to halt hair loss. I agree nothing is going to grow hair on bald scalp, but maintaining what you have is already possible with propecia, and will be possible with better alternatives soon I think.  No one knew anything about hair loss ten years ago. they now at least know  the basic pathways downstream of DHT activation, and that knowledge is bound to lead somewhere.  I don't remember any new drugs being trialled for MPB in the near-past except RU, which actually does work to some extent and is being used by many despite lack of approval.  Cell based treatments have failed so far because they weren't quite there with their knowledge.  
> 
> I'm pretty sure that anyone who can handle cetirizine (and most people can use zyrtec without major sides) or can afford ramatroban already has a better alternative to minoxidil.


 I can respect your contribution to this forum and agree with majority of your points above. 

Hopefully progress leads to treatments coming to fruition. That's my biggest thing. Let's see some treatments released, not press releases. 

Much respect tho. I'm with you in this fight.

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## StayThick

M


> well look at RU, it is really big now and readily available, and thats all a result of forums like this. So really that is what we can try and do with SET, or other such experimental treatments.
> 
> BTW, those negative posters like PatientlyWaiting, LongWayHome, StayThick, Hairismylife, why are you even in the experimental forum??? All you guys do is cry about hairloss. But never try to think outside the box and try to come up with a solution or alternative. Stop focusing on the problem and focus on a solution.
> 
> sdsurfin, good on you for trying to find a solution. Maybe it will work, prob wont, but at least we are trying something instead of just crying like babies and trying to disprove every far fetched idea


 You're an idiot. I don't spend my time crying about hairloss you Neanderthal. I'm in the camp that believes rubbing Chinese powders on your head in hopes to maintain a few follicles is not the route one should take. Yes, it's experimental and I have used RU personally, but that isn't the answer and comes with risk like anything in this category, but I digress.

My greater point is having legit approved treatments coming to market and enough with the false promises and press releases. People go on this section of the forum because there is nothing else outside of a Propecia and Minox that can help with their situation. This section is in existence for those willing to rub experimental Chinese powders on their head in hope that any studies conducted on the substance (if any) can have any impact on their hair.

We have no viable option now then we did decades ago to treat this condition. Period.

You can post about any herb and powder you want on this thread for home mixture. I wouldn't get mad at you, but I would shake my head. I frequent this forum for information on ANY potential legit treatments with potential releases to market...if that ever happens.

Nobody is crying here. I know what's reality and I sure as hell know what's available to treat my hairloss at the moment..and it's nothing in this section.

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## sdsurfin

> M
> 
> You're an idiot. I don't spend my time crying about hairloss you Neanderthal. I'm in the camp that believes rubbing Chinese powders on your head in hopes to maintain a few follicles is not the route one should take. Yes, it's experimental and I have used RU personally, but that isn't the answer and comes with risk like anything in this category, but I digress.
> 
> My greater point is having legit approved treatments coming to market and enough with the false promises and press releases. People go on this section of the forum because there is nothing else outside of a Propecia and Minox that can help with their situation. This section is in existence for those willing to rub experimental Chinese powders on their head in hope that any studies conducted on the substance (if any) can have any impact on their hair.
> 
> We have no viable option now then we did decades ago to treat this condition. Period.
> 
> You can post about any herb and powder you want on this thread for home mixture. I wouldn't get mad at you, but I would shake my head. I frequent this forum for information on ANY potential legit treatments with potential releases to market...if that ever happens.
> ...


 
How come you're not on ru anymore? Are any of you guys on steady ru with success? Thinking of trying it out.

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## Dan26

bro how did your HT go?

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## FearTheLoss

has anyone attempted to contact them in hopes of being a part of their POC trial?

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## Trouse5858

> How come you're not on ru anymore? Are any of you guys on steady ru with success? Thinking of trying it out.


 I'm about 2 months into RU with what I'd say is moderate success. I've taken before pictures so when I finish up in about a month, I'll be able to (hopefully) assess how much regrowth there has been but there's definitely been at least a little. Slight gyno on right nipple but I'll add to the RU thread with more details when I've run out of this batch.

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## FearTheLoss

I have been in contact with Kythera. They did confirm that they plan to go straight into a phase II study at the end of 2015/ or beginning of 2016 (so probably early-mid 2016 with how things work). Furthermore, if the results are positive they will be immediately going into a large phase III study. 

Does anyone know if this could be released in Asia immediately after phase II? 

Here's to hoping for positive results. The science is there, hopefully Cots' work wasn't for nothing because his credibility is riding on this as his discoveries are being put into trial.

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## It's2014ComeOnAlready

> I have been in contact with Kythera. They did confirm that they plan to go straight into a phase II study at the end of 2015/ or beginning of 2016 (so probably early-mid 2016 with how things work). Furthermore, if the results are positive they will be immediately going into a large phase III study. 
> 
> Does anyone know if this could be released in Asia immediately after phase II? 
> 
> Here's to hoping for positive results. The science is there, hopefully Cots' work wasn't for nothing because his credibility is riding on this as his discoveries are being put into trial.


 Excellent news. I had hoped it would be quicker, but this is good too. Hopefully they can file the NDA approval half way through phase 3, granting a somewhat earlier release.

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## Gerhard

> I have been in contact with Kythera. They did confirm that they plan to go straight into a phase II study at the end of 2015/ or beginning of 2016 (so probably early-mid 2016 with how things work). Furthermore, if the results are positive they will be immediately going into a large phase III study. 
> 
> Does anyone know if this could be released in Asia immediately after phase II? 
> 
> Here's to hoping for positive results. The science is there, hopefully Cots' work wasn't for nothing because his credibility is riding on this as his discoveries are being put into trial.


 This is both good and bad news. Good in the sense that they will definitely push forward with it. Bad in that we have yet another year to wait. I will tag this thread for a later date. Waiting around for updates would be exasperating. I want a cure, but constantly checking for one will drive me insane. For now all I can do is nibble at my propecia, hope my hair stays, and lift. Hopefully Cotsarelis pulls through - both for our sake and his own.

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## It's2014ComeOnAlready

I'm also hoping bim turns out to be good, and becomes available sometime relatively soon. Gotta cut down big time on the fin.

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## PatientlyWaiting

I've been here 5 years, but have actually been following hair loss treatments since 2006. Just because some one signed up on a baseball forum in 2010, doesn't rule out that they have been watching baseball since 1993.

And to the poster who listed me as a negative member, i've done all I had to do to fight hairloss. FUE, fin, rogaine everyday, tried other crap for 9 years. Also, I come here like how many times a year? 3-4 times? How am I always crying?

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## Scientalk56

> Let's see some treatments released, not press releases.


 Exactly!!!!!!

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## Scientalk56

for a moment i though u were talking about Histogen..
lol...


A moment of silence..

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## Scientalk56

> This is both good and bad news. Good in the sense that they will definitely push forward with it. Bad in that we have yet another year to wait. I will tag this thread for a later date. Waiting around for updates would be exasperating. I want a cure, but constantly checking for one will drive me insane. For now all I can do is nibble at my propecia, hope my hair stays, and lift. Hopefully Cotsarelis pulls through - both for our sake and his own.


 For a moment i though u were talking about Histogen..
lol..

A moment of silence

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## Energizer

Earlier in this thread there was talk of regrowth as well as maintenance. Is there the possibility that this molecule will be used with a novel administration method for regrowth (wounding?)?

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## It's2014ComeOnAlready

I know they know this works. A company worth $100 million wouldn't spend a tenth of it's money on HAIR LOSS treatment trials. I emphasize hair loss, because we know this has been like finding a needle in a haystack. They have found the needle and intend to make a lot of money.

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## NeedHairASAP

> I know they know this works. A company worth $100 million wouldn't spend a tenth of it's money on HAIR LOSS treatment trials. I emphasize hair loss, because we know this has been like finding a needle in a haystack. They have found the needle and intend to make a lot of money.


 They're worth $1B

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## It's2014ComeOnAlready

> They're worth $1B


 Sorry, I meant their available cash on hand. 1/10th is a lot.

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## HairlossAt15

> I have been in contact with Kythera. They did confirm that they plan to go straight into a phase II study at the end of 2015/ or beginning of 2016 (so probably early-mid 2016 with how things work). Furthermore, if the results are positive they will be immediately going into a large phase III study. 
> 
> Does anyone know if this could be released in Asia immediately after phase II? 
> 
> Here's to hoping for positive results. The science is there, hopefully Cots' work wasn't for nothing because his credibility is riding on this as his discoveries are being put into trial.


 How did you contact them? I cant find a email.

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## sdsurfin

Early release only applies to stem cell treatments in asia.  I'm hoping replicel moves fast in japan, but who knows.  Still no news of trials, and lots about tendinosis on their websites.  These things take forever, kythera's other double chin drug already passed phase three like a year ago and is still not approved.  

he only solution is to get these things on the black market.  If we pool our resources there's no reason not to start using setipiprant immediately.  I'm sure there are many chemists that can make it, I'm surprised there aren't some people on here with the right connections.  Get your emails out to Kane.

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## It's2014ComeOnAlready

I'm even more confident about the timelines for this treatment, because yes, it has to finish trials, but filing for a new drug application (NDA) can take place during phase 3. It just has to satisfy the FDA to the point that it's safe (already proven) and effective (can be determined in a POC). There has to be data on its efficacy in order for them to file. 

We'll have bimatoprost next year. Another year after that, we'll have setipiprant. 21st century treatments will be here soon.

Here are the requirements for passing an NDA as stated by the FDA:

-Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
-Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
-Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.

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## Keki

Doesn't bim have dangerous eye-related sides effect? My mum have an early glaucoma and an annoying floater in the eye, that eye drops goes systematic so you have to check everything often, and that's is timol, bim seems to be even more dangerous if we have no eyes issue

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## BiqqieSmalls

> Early release only applies to stem cell treatments in asia.  I'm hoping replicel moves fast in japan, but who knows.  Still no news of trials, and lots about tendinosis on their websites. * These things take forever, kythera's other double chin drug already passed phase three like a year ago and is still not approved. * 
> 
> he only solution is to get these things on the black market.  If we pool our resources there's no reason not to start using setipiprant immediately.  I'm sure there are many chemists that can make it, I'm surprised there aren't some people on here with the right connections.  Get your emails out to Kane.


 It will be approved in May 2015

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## It's2014ComeOnAlready

> Doesn't bim have dangerous eye-related sides effect? My mum have an early glaucoma and an annoying floater in the eye, that eye drops goes systematic so you have to check everything often, and that's is timol, bim seems to be even more dangerous if we have no eyes issue


 There are only eye related side effects if it is applied directly to the eye. If applied on the scalp, there are no side effects because bimatoprost doesn't go systemic. Dr. Alan Bauman has been prescribing latisse for hair growth, and has seen no side effects from it.

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## Keki

> There are only eye related side effects if it is applied directly to the eye. If applied on the scalp, there are no side effects because bimatoprost doesn't go systemic. Dr. Alan Bauman has been prescribing latisse for hair growth, and has seen no side effects from it.


 that's interesting,  i read this warning by fda http://www.fda.gov/NewsEvents/Newsro.../ucm109028.htm and another forum post that said he gave him a floater

I don't know what will happen in the future but for sure this stuff goes systemic even a little, every topical product tested from fina to minox goes sistemic in some dose, we must be careful, not many info right now

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## It's2014ComeOnAlready

> that's interesting,  i read this warning by fda http://www.fda.gov/NewsEvents/Newsro.../ucm109028.htm and another forum post that said he gave him a floater
> 
> I don't know what will happen in the future but for sure this stuff goes systemic even a little, every topical product tested from fina to minox goes sistemic in some dose, we must be careful, not many info right now


 Meh. It doesn't say anything about scalp application. People who post and read on this forum just assume or attribute hair loss medications to having very bad side effects because of the stigma attached to propecia. It's nothing but hysteria. I've seen dermatologists on camera saying that bimatoprost doesn't go systemic when applied topically to the scalp.

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