Kythera Acquires Rights to PGD2 Blocking Setipriprant for New Hair Loss Treatment

[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.

[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.

[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.

[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

[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

[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.

[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

[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.