Kintor has started Phase 3 trial in China for Pyrilutamide

Micky_007

Experienced Member
My Regimen
Reaction score
380
"On January 2, 2022, Kintor Pharmaceutical announced that the first male subject has received a dosing in their phase 3 pivotal trial of pyrilutamide. The phase 3 trial of pyrilutamide in male androgenetic alopecia will include:

Randomized, double-blinded, placebo controlled parameters

- 416 male trial subjects
- A duration of 24 weeks/6 months
- A primary endpoint of change in number of non-vellus target area hair count from baseline to week 24

Kintor remains ambitious in this press release, which has become their M.O., and states that they intend to complete this trial by the end of 2022. Dr. Youzhi Tong, CEO of Kintor Pharma, had this to say: “We look forward to completing the planned 416 subjects enrollment by June 2022, and the follow-up medical evaluation(6 months study + 1 month follow-up)within the year. With the goal of completing the phase III clinical trial this year, we are speeding up the process and expecting that KX-826 would benefit global patients as soon as possible.“

Credit: Follicle Thought

 

fashy

Established Member
My Regimen
Reaction score
175
First real alternative to finasteride possibly coming out next year, this is a huge milestone provided all goes well. Their phase II report will either make it or break it, we should know if we'll have the alternative we want and need this month (in case they don't delay the report again). Hard not to be optimistic though.
 

Pigeon

Senior Member
My Regimen
Reaction score
5,413
I will only get hyped after we know phase II results...

@whatevr what do you think? Will this go systemic too?
 

whatevr

Senior Member
My Regimen
Reaction score
3,638
I will only get hyped after we know phase II results...

@whatevr what do you think? Will this go systemic too?

We went over this in that other thread a few days ago. At the doses they are planning to use, it wasn't detected in the serum. But, I'll reserve judgement until I hear real world reports from users.
 

Micky_007

Experienced Member
My Regimen
Reaction score
380

Well atleast I respect Kintor's honesty when it comes to finasteride: "severe sexual adverse effects"


They also state their product doesn't effect androgen levels... I want to believe...

Yeah love the fact that they state "severe sexual side effects" with Finasteride usage, because it shows confidence and also, if Pyrilutamide side effects were anywhere near as bad a Finasterides, this statement could be used against Pyrilutamide.

Hoping for the best, yet staying cautious.
 

fashy

Established Member
My Regimen
Reaction score
175

Well atleast I respect Kintor's honesty when it comes to finasteride: "severe sexual adverse effects"


They also state their product doesn't effect androgen levels... I want to believe...

I do believe it doesn't affect Androgen levels, their own data from both phases I shows it does not go systemic therefore it would make sense that it does not. The million dollar question is how effective it is though. A topical AR antagonist that does not go systemic sounds great but it can also rouse skepticism about how potent it really is if does not penetrate the blood barrier at all.

Hopefully it also has longetivity in its effects and they do not decline 6-12 months in like CB or minoxidil. These are the 2 cruical aspects as to whether this will work or not. Fingers crossed.
 

Pigeon

Senior Member
My Regimen
Reaction score
5,413

On December 20, 2021, the kickoff meeting among key investigators for the KX-826 phase III clinical trial was successfully held. Peking University People's Hospital and Huashan Hospital affiliated to Fudan University led the trial, with 26 hospitals to be participating. After successfully co-leading the phase II clinical trial of KX-826 in China for the treatment of Androgenetic Alopecia, Professor Zhang Jianzhong from Peking University People's Hospital and Professor Yang Qinping from Huashan Hospital affiliated to Fudan University cooperate again to be the leading principal investigators (leading PIs) of the pivotal Phase III Clinical Trial of KX-826. At the investigator meeting, nearly 100 experts from 26 hospitals across China listened to the report on the efficacy and safety of the KX-826's Phase II clinical trial. Professor Zhang Jianzhong wrapped up the meeting and encouraged every PI to be engaged with this pivotal study with high quality and efficiency.


Dr. Youzhi Tong, founder, Chairman, and Chief Executive Officer of Kintor Pharma, commented, "Kintor's team has executed with high efficiency from the NMPA's clearance to the first dosing of this phase III clinical trial with around one month. This phase III clinical trial will be carried out in 26 top dermatology medical institutions across China. We look forward to completing the planned 416 subjects enrollment by June 2022, and the follow-up medical evaluation (6 months study + 1 month follow-up) within the year. With the goal of completing the phase III clinical trial this year, we are speeding up the process and expecting that KX-826 would benefit global patients as soon as possible."
 

fashy

Established Member
My Regimen
Reaction score
175
No word on whether phase II results will become public though, that's annoying.
 

Pigeon

Senior Member
My Regimen
Reaction score
5,413
No word on whether phase II results will become public though, that's annoying.
Heard rumours about them making it public in some dermatology conference? Haven't seen any proof though.
 

fashy

Established Member
My Regimen
Reaction score
175
Heard rumours about them making it public in some dermatology conference? Haven't seen any proof though.

Yes, I posted that in the other thread I believe because it was posted by a user in one of the discords who had contacted them. I saw the screenshot and it looked legit, but dermatology conference still doesn't tell us much.

Anyways, I emailed Kintor yesterday about this too so hopefully they respond.
 

byebyehair

Experienced Member
My Regimen
Reaction score
686

Well atleast I respect Kintor's honesty when it comes to finasteride: "severe sexual adverse effects"


They also state their product doesn't effect androgen levels... I want to believe...
Why the hell shouldn't they use every negative point of theyr competitors :D

I'm really excited for their report. Do we know if it will be an over the counter product or if u need suscription in china?
 

Micky_007

Experienced Member
My Regimen
Reaction score
380
Do we know what dosage they'll use in this trial?

Not that it matters for now seeing as we do not know for 100% certain if the chemical structure they are using in the trials is the exact same as the 2015 Patent for Example 12,which is the only one they claim direct comparison against RU.

They could have tweaked it a bit since then as 2015 was a long time ago, maybe as a way to throw a curve ball at those trying to replicate their findings before they release to market.

Similar theory I have about their Phase 2 results delay, my guess is that their holding their cards close to their chest because they know that once people find out how safe Pyrilutamide is potentially, people will try to obtain it ASAP via the Grey markets. So their probably going to release the remaining trial results close to the time of market release. That's just my guess, I could be wrong on it, but it makes sense from a business standpoint.

Also, since Pyrilutamide is said to be far stronger than RU, and we know that RU causes side effects for many people, I wonder if Microneedling with Pyrilutamide would be a big problem because it would cause far more systemic absorbtion of Pyrilutamide.
 
Last edited:

Pigeon

Senior Member
My Regimen
Reaction score
5,413
Honesty? It's called marketing. They are putting down the competition to inflate the potential gross market size and sales.
Marketing based on reality. Anyway hope this won't turn out to be the next big flop.

I'm very cautious with everything coming from China though


China’s ‘paper mills’ are grinding out fake scientific research at an alarming rate​


Seeking promotions and financial rewards, doctors and researchers are fueling a thriving industry that produces bogus studies for cash

 

thatslin

Member
My Regimen
Reaction score
20
Honestly, I know someone who was one of the participants of phase II trial and he was given placebo treatment as control. He said that many dudes from other test groups had real decent amount of hair regrowth after 6 months. Yes, regrowth. Pyrilutamide might work pretty well for many but the question is how long it will last and of course the sides. I remember CB0301 had awesome effect in the beginning and went sh*t after 12 months.
 

Pigeon

Senior Member
My Regimen
Reaction score
5,413
Honestly, I know someone who was one of the participants of phase II trial and he was given placebo treatment as control. He said that many dudes from other test groups had real decent amount of hair regrowth after 6 months. Yes, regrowth. Pyrilutamide might work for us but the question is how long it will last. I remember CB0301 had awesome effect in the beginning and went sh*t after 12 months.
What? You actually know someone who participated in Kintor's trial? Are you chinese? Edit: Or they're doing phase II trials in US too?
 
Last edited:
Top