Kintor Pharmaceutical's KX-826 Pyrilutamide Phase 2 Results LEAKED?!

I wanted to give you another brief update on Kintor Pharmaceutical's KX-826, also known as pyrilutamide, which is a topical non-steroidal anti-androgen that is currently undergoing phase 3 clinical trials in China, and is expected to be completed sometime mid/end of this year. This means that if all goes well without any issues, we can expect commercialization and potentially have the opportunity to purchase this topical anti-androgen in China hopefully as early as 2023. I'm not exactly sure how expeditious China's FDA approval process is but the U.S. is also currently undergoing phase 2 clinical trials on pyrilutamide so hopefully we'll also get some good results from it.

In my last video on Kintor Pharma, I gave an update stating that the highly anticipated phase 2 clinical trials that were already completed in China were to be released sometime this month in June 2022, but unfortunately, that is yet again being pushed back to September 2022. It really is a bummer because so many people are waiting for a much needed update, but according to Kintor Pharma, the reason behind this postponement is due to a recent increase in cases of a certain flu strain in China, so until they are able to contain this pandemic and sort things out, it sounds like they won't be able to post up any of their phase 2 clinical trial results. 

This is absurd and crazy because it's now been almost a full year since they announced that phase 2 clinical trials were successfully completed as of September 2021, and honestly speaking, I really don't even know of any other hair loss companies that delayed this long in publishing their clinical trial results. Most companies would publish their results, whether good or bad, in a relatively short period and timely manner after completion of the trial, but for some strange reason, Kintor Pharma has just been delaying it over and over again. It's not like they don't have the data in hand and they're been green lighted to proceed with phase 3 clinical trials, so I don't know why it's so difficult for them to just announce the findings. They've literally had a whole year to compile a data spreadsheet, upload it to their company website and share it with stakeholders, but it looks like we're at their mercy yet once again and we are gonna have to wait until September at the earliest, and this too, can unfortunately be pushed back even further to a later date. Hopefully that won't be the case but what's funny is that even if they release phase 2 results in September, they'll already most likely be done with phase 3 clinical trials by then, and that too will obviously be pushed back to a later date.

Now things get more interesting - apparently, there was an image circulating on Discord groups and on Reddit with a potential screenshot from a presentation of Kintor showing phase 2 clinical trial results of 2.5 and 5mg pyrilutamide. I can't say how legitimate this is but I find it difficult that someone would want to fabricate and post up fake phase 2 clinical trial results, especially if they have no incentive doing so, so I'm going to give them the benefit of the doubt and assume that this is indeed the leaked phase 2 clinical trial results that we have all been waiting for.

kintor pharma kx826 pyrilutamide phase 2 results

The presentation above is titled Baseline Characteristics and Efficacy Analysis. On the far left hand side, we have the mean age which is around 35 years and let me remind you that this was for 120 male subjects initially. We also can see the BMI, and they also categorized those who smoked/didnt smoke - I'm not sure how relevant that information would be. And then the last column has the severity of androgenic alopecia. Those who were between NW 3V, all the way up to a NW 5 were the ones being tested in this trial.

The column on the right shows the Efficacy Analysis: change from baseline at week 24 in non-vellus target area hair count. I will note that the study does not specify what the target area hair count is measured in but I think it's safe to say that this target area is most likely 1cm^2 as most studies are measured by 1cm^2 when calculating hair count in this magnitude. After 24 weeks, 2.5mg twice a day of pyrilutamide yielded an average of 14.75 hairs per cm^2, 5 mg of pyrilutamide yielded about 22.73 hairs, and then the placebo had resulted in 9.43 hairs. This means that there was a difference of about 5 hairs between placebo for 2.5mg and 12 hairs between placebo and the 5mg dose. In conclusion, change from baseline at week 24 in total area hair count of KX-826 5mg twice a day had statistically significant increase than the placebo group.

finasteride efficacy

For reference above, .25 % topical finasteride and 1mg oral finasteride yielded roughly a target area hair count of about 20 hairs/cm2 in 24 weeks - probably a bit less if you account for the difference in placebo as well. 0.5mg oral dutasteride is known to be more efficacious than finasteride and based on a few available studies,


dutasteride roughly increased anywhere from 20-23 hairs per cm^2 from baseline to 24 weeks. I will say that these target area hair count increases per cm^2 will slightly differ depending on the study being referenced, but in the grand scheme of things, the results from phase 2 clinical trials of pyrilutamide is looking pretty optimistic. It's almost as comparable to that of finasteride and dutasteride, and even potentially better. We will have to wait on the official phase 2 clinical trial results from Kintor, but if the presentation is indeed what the actual results were from phase 2 trials, pyrilutamide will be another incredible hair loss treatment stack that we can all incorporate into our hair loss treatment regimen. Another thing to add is that these are results from 24 weeks. There's also a good possibility, just like finasteride and dutasteride, that pyrilutamide can have a more efficacious result after long term use, so this is also something we need to keep an eye out for. 

Pyrilutamide works in a different mechanism of action by directly blocking the androgens from binding to the androgen receptors as opposed to fluctuating the hormonal profile and I am optimistic that adding a topical anti-androgen on top of 5 alpha reductase inhibitors and minoxidil will greatly help stabilize further hair loss with the potential to promote new hair growth. Pyrilutamide has shown to have a good safety profile without any serious adverse events, and because it is applied topically as opposed to oral ingestion, there likely will be very miminal side effects as it does not get metabolized by the liver and minimizes going systemic. People who are not able to take current FDA approved hair loss medications like finasteride or dutasteride for whatever reason will potentially have an alternative medication to take, so I'm really looking forward to the commercialization of KX-826.

I'm really excited about Phase 2 and 3 clinical trial results and like I mentioned before, this is by far one of my most favorite anti-androgens that is currently in the research pipelines. I hope it pulls through and fingers crossed, hopefully as early as 2023, we will finally have another hair loss treatment that we can incorporate into our regimen. Kintor has been really good as far as meeting endpoints with their studies, so i'm  fairly optimistic about this company. I'll keep you guys updated as soon as I get more information. 

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