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

[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.