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

[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

[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?)?

[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.

[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

[It's2014ComeOnAlready]

They're worth $1B

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

[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