Kintor’s KX-826 Pyrilutamide Meets Goal In Phase 2 Trial
Kintor Pharmaceutical of China brings us some timely good news today regarding its lead candidate drug KX-826 for the treatment of androgenetic alopecia.
Phase 3 Will Be Soon
A well respected company in the hair growth industry, Kintor Pharmaceutical, continues to outpace the competition. In a press release issued today, the company announced that KX-826 aka pyrilutamide, an androgen receptor antagonist, successfully completed a phase 2 trial for male AGA in China. The study enrolled 120 male subjects and was completed over a 6 month period. No major adverse events were reported and the majority of adverse events reported were mild. With a good safety profile in hand, Kintor Pharmaceutical is planning to commence a phase 3 trial in China by the end of the year.
Full statistics of the phase 2 trial are not available yet other than the announcement that KX-826 created a statistically significant change in non-vellus hair count in a targeted area compared to placebo. This is something that Histogen and Follicum were recently unable to do. A full report with detailed clinical data from the phase 2 trial of KX-826 in China is set to be released sometime in Q4 2021, which will coincide with the initiation of a phase 3 trial for male AGA in China. Additionally, Kintor mentions that it is currently planning a phase 2 trial for female AGA in China. Good news all around.
Thank you Kintor for showing us that it is indeed possible to make steady progress in alopecia-related clinical trials and stick to proposed timelines.
Posted in Kintor Pharmaceuticals
This upcoming detailed report from Kintor is huge. Is it comparable to finasteride? What % increase did it create? If it contains photohgraphic data that will be a great sign. I’m at the beginning stages of excitement, but we’ll still have to see further evidence.
What is the application method for this product and when might it be available if you had to guess?
Pyrilutamide is topical. If it succeeds in a phase 3 trial, 2023-2024 is possible I’d say in China.
I have recently read some articles about IGF-1 hormone and how it affects hair loss/growth. Is there any truth to this and is any company researching this as a possible cure?
Lots of studies show that IGF-1 plays a role, and maybe a big role in hair growth. I believe the HaircellStim company may be incorporating it into their technology, but I don’t know of anyone using an injection or drug at the moment.
It is definitely good news, but personally I couldn’t wait anymore for Breezula or this one, so I started using topical finasteride, which is finally available from a reliable pharma company.
Sounds good, Dale.
Interesting response from Biosplice.
Actually quite positive, it’s not completely dead and come to market if they find a partner, sell license, etc.
If only we knew what the results were of their phase 3…
Who did you end up going with for topical fin? Seems like their are so many choices.
Do you notice any sides from topical?
I was just abiut to order and don’t know where to get it from. I did oral propecia for about 15 years. Fine in the beginning but the last year or so wrecked my neuro endocrine system. Took a while to recover but loosing so much hair lately though I might try topical.
I go through struthealth for pills but they also do topical solutions if you live in the U.S. and (I think) Canada.
This is very good news to hear after the disappointing biosplice news. Glad they are doing a trial in women too.
The methods Kintor and Cassiopea are taking have been proven somewhat with winlevi, and with Kintor having the more powerful drug.
Any good news from them is the best bet we have to have something out before a long wait for anyone else to catch up.
Also Admin I got a response from Biosplice just now.
“Biosplice is not pursuing further independent development of SM04554 for androgenetic alopecia and is evaluating global out-licensing opportunities for further development and commercialization of this program.”
Odd way of canning it. If they know the phase 3 trial didn’t work it seems they might just pawn it off the someone else. Interesting to see if anyone else picks it up
I agree there is something odd about Biosplice’s communications around SM04454. Luckily, we have (hopefully) something better to follow now.
SM04554
Thank you for your interest in Biosplice’s investigational drug, SM04554.
Biosplice is not pursuing further independent development of SM04554 for androgenetic alopecia and is evaluating global out-licensing opportunities for further development and commercialization of this program
Just let the Bezula investigate, only when they are done and when they are done I wonder to whom will they sell the medicine when the kintor will conquer the world with his medicine.
Does anyone know if any of the hair restoration products really work
This will probably be taken over by a company from Turkey. Because Osman is Turkish and they had a phase 3 test in Turkey
You probably need other components not just SM04554.
This is great news admin! Thank you for always keeping us updated!
Really glad to see Kintor meeting timelines and just flying through the clinical trial process. It’s a breath of fresh air.
I’m hoping the results in the detailed report are actually good and that Kintor Pharmaceuticals use this Phase 2 data from the China Trials to submit to the FDA so that they can hopefully bypass the Phase 2 Trials in USA as well.
It would be great news if that is possible.
I’m also waiting to find out what type of side effects were experienced on Pyrilutamide and why I was considered mild.
Ofcourse we have to keep some scepticism with everything until there’s proof and only the detailed report due in 2021 will give us an idea.
It would be massive if the results of Pyrilutamide are better than Finasteride with a lower risk profile.
“and why it* was considered mild” – excuse the typo
I think Kintor is the only company that truly has the potential to succeed in the “short” term.
I only worry about potential side effects. No major adverse events, but most adverse events reported were mild? I hope for stats and pics to follow!
Kintor ftw!
Thanks it’s the best news we had for some time
Thanks for the update FT.
Any news on what’s happening with Kintor’s phase 2 trial in the US?
Kintor started the Phase II trial in the US already according to another site. That may just mean they started recruiting.
Typically, Kintor would send out a press release stating that the first patients have been dosed in a phase 2 trial in the US which it has not yet. Until we get that word I’m not confident that the trial has actually “started” yet. Doesn’t matter much in my opinion, it will not be long before the next press release with good news from Kintor.
Link to press release
https://en.kintor.com.cn/news/190.html
In-depth info on Kintor’s approval and distribution strategy + time line. Apparently as of July 2021 they expect US FDA approval by 2023E.
http://pdf.dfcfw.com/pdf/H3_AP202007241393752560_1.pdf
A link to the press release was already in the article Anthony. And, that document is from July 2020 Anthony, but thanks for sharing.
Admin, quick random question. Any advice on where to get topical finasteride from? Also, any input on side effects from topical?
I used oral prop for years wanted to try topical.
Thanks!
Keith, did you catch this article? https://folliclethought.com/the-rise-of-mail-order-topical-finasteride/ Maybe someone else has personal experience with either brand. Side effects tend to be less frequent and severe from topical use. It’s easier for a user to really precisely regulate the amount of the drug they are applying. Hope this helps.
When will we be able to buy it in europe? Do they have to run another trial?
Probably like 5-6 years
Looking forward the forthcoming trio : Samumed, Kintor, Breezula. Combining those 3 by 2025 will regrow at least a whole norwood I hope.
Sorry to hear about the sides Keith. Topical finasteride has been in development for many years, studies have been published, at least two pharma companies have been involved, and now it has finally reached the market in selected European countries, including Germany where it is produced…
…I can give more details as long as it’s clear I’m in no way associated with them! But maybe this should go in a separate thread…?
Hi Dale wehre Can I buy topical Finasterid in Germany?
I don’t like China but I’m surprised no Chinese companies have approached tsuji would be nice if China did hair cloning trials with the speed they are going.
Hey Admin.
Update from Cassiopea. Phase 2 trial for women has the results released
https://www.cassiopea.com/2021/09/10/cassiopea-spa-announces-topline-results-of-phase-ii-proof-of-concept-trial-of-clascoterone-solution-for-the-treatment-of-androgenetic-alopecia-in-females/
Disappointing that is seems to not work well on women older than 30. They seem to take it as an indicator that FPB is less influenced by androgens than men. Which does make sense. As fin was the same for women.
Still hopeful it’ll work for anyone AMAB but it’ll be a shame if this means less affective on women.
Thanks sky, it appears that the trial itself did not reach statistical significance for women.
Yeah it was disappointing. However more data on the side affect profile with (as far as I can tell from reading) them all being mild. And at least it means progress.
Now it seems both Kintor and Cassiopea are at fairly similar stages. With Cassiopea in the lead due to Winlevi already having a preduction line set up.
Seems we will know if either could be a new solution on the market in the next year or so
Hi Fako, in the country where I live you can order it from a local pharmacy, I assume it is the same in Germany?
hey yoda are you still here?
Yoda still reads the site but decided to retire from the comments section.
Hello admin!
Good news. Thanks also for the tireless replacement and competent reporting.
Hi,
https://www.tesseratherapeutics.com/news
This is a gene writing company, which has skin in its focus area.
Admin, is it possible for you to contact them and check if their tech could treat hair loss as well.
Thanks
I will give it a consideration AD, their treatment area seems like the whole body for now, so it will be lucky if hair is really in their plans at the moment. And thank you for sharing it.
Admin
I will buy PTD-DBM with valproic acid .
This is the treatment of male pattern baldness based on studies.
Anyone in favor of the idea?
Is it a definitive cure for baldness?
Will the hair fall out again after finishing treatment for 3 months or 6 months?
Knowing that PTD-DBM is very expensive
Please help from forum members
I thought they had completed their phase 2 trails in July, as it was mentioned in a a press release then.
But still hopeful for a 2022 release date
If you’re talking about kintor. They’d did complete them then. This is just them releasing the results
Very exiting news. Like you said, we have to keep some level of scepticism, but sounds very encouraging none the less. Looking forward to reading the data when they release it. Thanks for the update FT ??
@FollicleThought, would you mind getting an itw with Queen Pr. Xiao Rui-Ping, who’s the only one that can save us in the short term? Thx.
I wouldn’t mind Nugget, however, please understand I’ve already tried and she has not responded.
@FollicleThought , I read their news release and in it they said they were going to have an accelerated phase 3, what does that mean? As phase 2 was 7 months, could this be shorter ?
Thank you
This sucks man! I went years of fighting it with propecia it fucked me up bad.
I come off for 8 years held ok for a while and now have shed like a dog the last week. Real to point of no return.
I coach little league ball and 8 other dads there yesterday all fing perfect NW zeros. Wtf 8 40 year old dudes all with perfect hair!
It’s bullshit something these guys never even once gave a thought or worry to.
If you’re talking about Kintor, I believe they just mean accelerated as they will go as quickly as the trial can take.
Not that the trials length will be any shorter as they need the time to prove efficacy. But the speed at which they work will be as efficient as possible.
If they are looking at a 2023 release it’ll probably be at least 7 month trial. However I’m expecting it to be around 9 months so they can have as much chance to demonstrate improved results over the 6 months mark the finnesteride peaks at.
If breezula has not shown good results in women ,is it possible for the same for pyrilutamide ,as both drugs work on similar lines
Anything is possible of course, but we’ll have to wait for a clinical trial to decide because they are different molecules.
Thank u for response
My name is Breno, 33 years old and I’m from Brazil. I was very interested in this medicine. I have been treating my baldness since I was 20 years old. I’m very interested in it coming out soon, I believe it comes out in 2023
Has Kintor made any mention about EU/UK approval?
Also would they be able to use the clinical trials they have already done for approval or would they have to start a new set of trials for those?
I haven’t heard anything regarding EU approval, but it could have been mentioned in the footnotes somewhere. I believe they can go directly to phase 3 in EU if they are at phase 3 in the US, but not sure about that.
Great news!
Great news. I honestly hope that after FDA Approves KX826 it’ll also be available on UK. Will it be just as expensive like Breezula? Hopefully this finasteride alternative will be released in 2/3 years from now..
No one knows the price at this point, and even still, no one knows how much Breezula will cost on average with insurance.
Wow, if this stuff worked, with little to no side effects, and they manage to put it on the market within the next 2/3 years I could avoid finasteride and MAYBE even hair transplant…
I’m 26, never taken anything and still in a situation, by and large, acceptable.
If this miracle happens I could even start reconsidering my atheism lol ironic since it would come from a communist country haha
Finger crossed ? optimistic but no delusional!
Hi Arios,just want to share with you an exiciting new – Kintor has just been approved to start the phase III trial by NMPA(National Medical Product Administration)in China!This is literally the first drug that enters this phase except for Fina and Mino and the speed of Kintor is also remarkable.So I think it is very probable for us to see this drug on market in the next 2 years. =-)
@=-)
Hey sorry, I didn’t notice your reply! Yeah, I’ve read it, it sounds very good! Now let’s wait for the results of phase II.
Whatever happens, I like this company because it proceeds with a reasonable pace! I don’t know how KX-826 will end up, maybe it won’t work, I don’t know, but the mere fact that they are not taking centuries from a phase to another makes me like them!
Let’s hope my friend!
Does anyone have an estimate on the price of this drug and Brezulla?