In my regularly updated post on Kintor Pharmaceutical (China)’s clinical trials, the latest development was that Kintor was launching a KX-826 (Pyrilutamide) based cosmetic product. They received International Nomenclature Cosmetic Ingredient (INCI) approval in June 2024.
KX-826 Hair Growth Spray Launched
Now the product is for sale on Amazon at a price of $69 for a 1-month supply. It is made by Koshine Biomedica (China). It comes as a topical spray. There are no reviews or product ratings at the time of writing this post. The product description mentions the product as being a dihydrotestosterone (DHT) blocker.
Note that the actual androgen receptor antagonist KX-826 is still in Phase 3 clinical trials in the US and China. The cosmetic product (image below) is a way for the company to release a topical product faster.
Kintor Pharmaceutical (China)’s KX-826 Cosmetic Androgen Receptor Antagonist. Made by Koshine Biomedica (China).
Also of interest, one of the images on Amazon implies more rapid hair growth from this spray product in comparison to FDA approved Minoxidil:
KX-826 versus Minoxidil hair growth comparison.
Usage Instructions
The instructions on using this KX-826 spray are as follows:
Open the outer packaging and insert the spray head onto the bottle.
Find your area of hair loss, use your fingers to expose the scalp, and then apply the anti-hair loss liquid spray.
Use once in the morning and once in the evening. For a total of 6-8 sprays each time, which equates to about 1ml.
Massage the scalp for about 3 minutes after the spray has been applied.
Note: Only meant to be used when your scalp and hair are both dry.
Kintor Pharmaceutical: KX-826 and GT20029 for Androgenetic Alopecia
My original post on Kintor Pharmaceutical (China) has become way too lengthy after so many updates. Therefore I will add all new developments in this post (below this product introduction section).
This rapidly moving well funded company is in Phase 2 and Phase 3 trials in the US and China for both its male androgenetic alopecia (AGA) products. Kintor (pipeline here) is conducting hair loss trials for:
Two separate androgen receptor (AR) targeting products: a degrader (GT20029) and an antagonist (KX-826 aka Pyrilutamide).
Each of these trials is being conducted in both China and the US.
Each of these products is being tested for both males and females with androgenetic alopecia (aka pattern hair loss).
i.e., a total of 8 types of clinical trials times 3 phases in each = 24 developments we have to track. A bit too much if all of these do end up taking place, but a most welcome development. Over one-half of these 24 potential trials are already finished.
The GT20029 product is an androgen receptor degrader (AR Degrader). It is developed using Kintor’s proprietary Proteolysis Targeting Chimera (PROTAC) platform. This is the world’s first topical androgen receptor (AR) compound (AR-PROTAC) to enter clinical trials. GT20029 degrades the AR protein via the E3 ubiquitin ligase pathway. During preclinical studies, GT20029 did not cause any notable side effects or systemic drug accumulation.
Kintor’s main product for treating male pattern hair loss is KX-826 (Pyrilutamide) and is an androgen receptor antagonist (AR Antagonist). KX-826 is currently in Phase 3 clinical trials in both China and the US per the pipeline chart. In China, these trials are now completed.
Note that Cassiopea’s Breezula (Clascoterone) is an AR antagonist that is also currently in Phase 3 trials in the US. Kintor’s website has an interesting article discussing both these competing AR antagonist products and hair loss.
Kintor Launches Cosmetics with KX-826 as the Main Ingredient
Kintor Pharmaceutical has officially launched a line of cosmetics with KX-826 as the main ingredient. This is the second widely discussed hair loss product that has been launched in the past two years as a cosmeceutical (with the first being CosmeRNA).
Update: June 5, 2024
KX-826 Receives The INCI Cosmetic Designation
Kintor Pharmaceutical’s KX-826 (Pyrilutamide) has received the International Nomenclature Cosmetic Ingredient (INCI) approval from the International Cosmetic Ingredient Nomenclature Committee. The assigned INCI name is Methylpyridinyl Fluoromethoxybenzonitrile Dimethyloxothiooxoimidazolidine. INCI names are recognized worldwide when identifying cosmetic ingredients. This development will facilitate the potential future global launch of Kintor’s line of cosmetics that have KX-826 as the main ingredient.
Update: May 24, 2024
More Effective KX-826 Tincture 1.0% versus 0.5%
Kintor’s clinical trial of KX-826 tincture 1.0% for treating male androgenetic alopecia in China just received clearance. The company’s pre-clinical studies showed that KX-826 tincture 1.0% had a significantly higher retention concentration level on human scalp cells compared to KX-826 tincture 0.5%. The latter was used in the Kintor’s previous phase III clinical trial.
Update: April 22, 2024
Positive Update on GT20029 Phase 2 Clinical Trial
Kintor Pharmaceutical just announced that its China Phase II clinical trial of its first-in-class androgen receptor (AR) proteolysis targeting chimera (PROTAC) compound GT20029 for treating androgenetic alopecia has reached the primary endpoint. The results are statistically significant and clinically meaningful, while safety and tolerability is good.
GT20029 demonstrated statistically significant efficacy compared to placebo in both the QD (once a day) and BIW (twice a week) dosing cohorts.
After 12 weeks of treatment, the 0.5% QD GT20029 group showed an increase of 16.80 hairs/cm² from baseline. This was 6.69 hairs/cm² more than the placebo group.
The total area hair count (TAHC) of GT20029 1.0% BIW group showed an increase of 11.94 hairs/cm² from baseline. This was 7.36 hairs/cm² more than the placebo.
The 1% BIW dosage of GT20029 was identified as the optimal dosing level and has been recommended for the phase III clinical trial in China.
Key Quote:
“Based on the results of the Phase II clinical trial, the company will actively deploy subsequent clinical strategies for GT20029, such as initiating a phase III clinical trial in China and a phase II clinical trial in the US for male AGA.”
Update: February 1, 2024
Clinical Trial of KX-826 and Minoxidil
Kintor Pharma is undertaking clinical trials for two different androgen receptor targeting hair loss products (KX-826 and GT20029); in two countries (US and China); and for both males and females.
Now comes news that Kintor will also undertake Phase 1b/III clinical trials of KX-826 in combination with minoxidil for the treatment of androgenetic alopecia (AGA). The trial was just cleared by the National Medical Products Administration in China.
Update: November 27, 2023
Maybe Bad News for KX-826 Phase 3 Trial Results
According to this Reddit source, the results of the Chinese Phase 3 trials for KX-826 (aka Pyrilutamide) were ok, but not good enough. There were no serious adverse events or side effects. And positive hair growth was observed when compared to baseline (at all visit points) after 24 weeks. However, compared with the placebo group, the total area hair count (TAHC) improvement in the KX-826 treated group had no statistical significance. Albeit there was a “trend in efficacy observed”.
On a positive note, Kintor plans to continue with its multiple KX-826 related trials (in the US and China) for the topical treatment of androgenetic alopecia. I appreciate the speed with which the company released these findings. I expect there will be an official press release in the next few days. Edit: Seems like this never happened?
November 18, 2023
Phase 3 Trials for KX-826 (Pyrilutamide)
KX-826 (Pyrilutamide) is currently in the most advanced stage and has a good chance of coming to market in China by the end of 2024. In Kintor’s pipeline page, it is shown to be in the final stage of Phase 3 trials for men in China; and early stage of Phase 3 trials for men in the US. Moreover, it is also in the early stage of Phase 3 trials for women in China.
Kintor is also undertaking a second Phase 3 trial in China for long-term safety of KX-826, which I discussed in detail in my original post. Even more exciting, one my Chinese readers sent me the below partial translation of a new October 2023 presentation by Kintor. He said that his English is not good, but I only changed a few words that were confusing or out of place.
“KX-826 is a topical androgen receptor (AR) antagonist independently developed by Pioneer Pharmaceutical. It is the first AR antagonist in the world to enter phase III clinical trials for the treatment of hair loss. KX-826 binds the AR by competing with dihydrotestosterone (DHT) to locally block androgen-mediated signaling to limit hair follicle miniaturization and promote peripheral hair growth. After reaching the circulatory system, KX-826 is rapidly metabolized into inactivated metabolites, which has little influence on the whole body AR signaling pathway and has good safety.
The Phase II clinical trial in China included 120 men with hair loss. Of these, 90 subjects were randomly assigned to KX-826 0.25% twice daily, KX-826 0.5% once daily, and KX-826 0.5%, and the remaining 30 subjects were randomly assigned to placebo. After 24 weeks of treatment, the 0.5% concentration group of KX-826 showed a significant improvement in the amount of non-vellus hair in the target area. An increase of 22.73 roots per square centimeter compared to baseline.
Finally, news about Phase III: KX-826 is currently in or planned for five Phase III clinical trials (two in China and three in the United States). Among them, the Chinese Phase III clinical trial of KX-826 for male alopecia has completed the last subject visit, and the company is making full efforts to promote the data collation, library un-blinding and data statistical analysis of this clinical trial.”
Phase 2 Trials for GT2009
In Kintor’s August 22, 2023 update, they announced the completion of patient enrollment in Phase II clinical trials of GT20029 for male pattern hair loss in China. The current pipeline shows that these trials are almost over in China, and close to beginning in the US.
