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. Further details are broken out in the bottom half of this post and in my original post for Kintor that became too lengthy.
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.
November 27, 2023
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 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. Moreover, 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.
November 18, 2023
Kintor Pharma: KX-826 and GT20029 for Androgenetic Alopecia
My original post on Kintor Pharmaceutical (China) has become way too lengthy after so many regular updates. So I will now add all new developments here. This rapidly moving well funded company is in Phase 2 and Phase 3 trials in the US and China for both its two androgenetic alopecia 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 done (see my new update further below).
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.
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.
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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.
Kintor Pharmaceutical (China) is definitely the real deal. They are moving faster than any other company in the history of the hair loss industry. Moreover, they are conducting hair loss trials for:
Two separate androgen receptor (AR) targeting products: a degrader (GT20029) and an antagonist (KX-826 aka Pyrilutamide).
Each of them in two countries (China and US).
Each of them for both males and females with androgenetic alopecia (AGA).
So potentially 2*2*2*3 phases =24 clinical trials (plus any pre-clinical work)! Hence my excuse for this post becoming very disjointed. The newest updates are on top. The latest July 2023 pipeline from their site is shown in the below image:
Kintor Pharma updated pipeline for Pyrilutamide (KX-816) and AR-PROTAC (GT20029).
Update: July 19, 2023
Kintor Begins Enrollment for Second Phase III Trial for KX-826 in China
This is insane. If you recall, in March 2023 (see further below), Kintor announced that it had completed enrollment of 740 subjects in China and was beginning Phase III clinical trial of its KX-826 (pyrilutamide) androgenetic alopecia product.
Today, Kintor announced that it has also initiated a long-term safety Phase III trial of KX-826 with the first patient just enrolled. A total of 270 male and female AGA patients will be enrolled to evaluate the long-term safety of topical KX-826 for the treatment of AGA patients in China. The treatment period will last 52 weeks.
At the top of this post, I mentioned that Kintor could conduct 24 potential trials related to its hair loss products (plus preclinical work). It seems like they might be shooting for an all-time world record 32 trials! Most likely, they will not do two Phase III trials in every case. Nevertheless, this company is unlike any other that we have ever seen in our lives. All the stereotypes about Chinese product safety issues and trial shortcuts are clearly not apt in this case.
This is the first time in the history of the hair loss world that a company seems to have absolutely no financial restrictions in conducting clinical trials. That too in two countries (including the stricter US), with no significant delays at any phase of the process thus far.
Update: May 11, 2023
Phase 2 for KX-826 (AR antagonist — Pyrilutamide) Completed in the US
Kintor Pharmaceutical announced that the Phase II clinical trial of its KX-826 molecule for the treatment of male androgenetic alopecia in the US was completed successfully. The results are statistically and clinically meaningful with an increase of about 10 hairs per cm2 after 24 weeks of treatment with 0.5% BID KX-826. The safety profile was also favorable and the company plans to meet the FDA and pursue Phase 3 clinical trials. Note that this same 2 trial was already completed in China last year, with a superior result of a hair count increase of 22.73 hairs per cm2.
Update: April 14, 2023
Phase 2 for GT20029 (AR degrader) Begins in China
Kintor Pharma just completed the first patient enrollment in China for its proteolysis targeting chimera (PROTAC) compound GT20029. The Phase II clinical trial is a multi-center, randomized, double-blind, placebo-controlled study. It will evaluate the efficacy and safety of androgen receptor degrader GT20029 for treating male pattern baldness in Chinese adults. Kintor plans to enroll a total of 180 male AGA patients from 12 centers nationwide.
Update: March 28, 2023
Phase 3 for KX-826 (AR antagonist — Pyrilutamide) Begins in China
Kintor just completed enrollment of 740 subjects in China for its Phase III clinical trial of its KX-826 (pyrilutamide) androgenetic alopecia drug candidate. It expects to release the top-line data in Q4 2023. If the data is positive, the company plans to proceed with the NDA application with the China NMPA.
Update: March 21, 2023
Kintor Pharma Presentation at AAD2023
At the just concluded American Academy of Dermatology Association (AAD) 2023 meeting in the US, there is an interesting update from Kintor Pharma. The renowned Dr. Ken Washenik made a presentation on both of Kintor’s androgenetic alopecia products: pyrilutamide (KX-826) and GT20029. His talk was titled: “The Emerging Potential of Topical Androgen Modulators in Androgenetic Alopecia”.
Besides discussing clinical trial data, Dr. Washenik highlighted the emerging potential of topical androgen receptor (AR) modulators in the treatment of pattern hair loss. Key quote:
“The potential of an effective topical AR blocker without systemic side-effects has long been promising.”
Latest Clinical Trial Status
Per this latest news release (and their pipeline page), Kintor’s latest status of trials (as of March 2023) is as follows:
Conducting Phase III clinical trials in China of KX-826 for male AGA.
Conducting Phase II clinical trials in the US of KX-826 for male AGA.
Planning Phase III clinical trials in China of KX-826 for female AGA.
Conducting global multi-center Phase III clinical trials of KX-826 for male and female AGA.
Analyzing results of completed Phase I clinical trials of GT20029 for the treatment of AGA in China and the US.
At the same AAD conference, Dr. Adelaide Hebert also discussed Kintor’s KX-826 for the treatment of acne. It works by competing with dihydrotestosterone (DHT) for binding to ARs. It inhibits gene expression that in turn reduces sebum production and inflammation.
Update: December 1, 2022
Kintor Phase 2 Results for KX-826 in Females
Not surprisingly, yet another positive Kintor update. Their Pyrilutamide (KX-826) phase 2 clinical trial results for females with androgenetic alopecia just got released. And the findings are positive. Total area hair count (TAHC) increased 11.39 hairs per cm2 compared with the placebo group after24 weeks of treatment. It seems like they are going with a dosage of KX-826 5mg (0.5%) once a day, even though twice a day was also tested.
The overall safety profile of Pyrilutamide in females was good, and no participant needed to drop out due to any adverse event. Note that these results, whilst encouraging, are less than half what was seen in men (22.73 hairs per cm2 increase). See further below for the prior updates on the male trials. Both these Phase 2 trial were conducted in China, and Kintor is expected to conduct Phase 3 trials for men and women in China too.
Update: November 24, 2022
Phase 1 Trials for GT20029 a Success
Kintor’s just announced positive top-line results for its Phase I clinical trial of GT20029 for the treatment of androgenetic alopecia and acne. GT20029 is the world’s first topical Proteolysis Targeting Chimera (PROTAC) compound that has completed Phase I clinical trials. It works by degrading the androgen receptor. The topical administration of GT20029 was safe and well-tolerated, with limited systemic exposure. Note that this study was in China.
Kintor Releases KX-826 Phase 2 Trial Results in Males
Kintor just released the Phase 2 results from China on their website and they are positive. Note that this Pyrilutamide (KX-826) topical hair loss product is an androgen receptor antagonist. In contrast, existing hair loss products Finasteride and Dutasteride are both oral DHT inhibitors.
Key quote:
“The results showed that the KX-826 (0.5%) 5mg BID group demonstrated significant improvement in TAHC as compared with the baseline (increased by 22.73 hairs per cm2; and placebo group (increased by 15.34 hairs per cm2) after 24 weeks of treatment. The recommend phase III dose is determined as KX-826 (0.5%) 5mg BID.”
Note that BID means twice daily. A total of 120 Chinese adult male subjects with a mean age of 35.6 were enrolled in the study. All had a Hamilton-Norwood classification III or higher balding pattern. They were equally divided into four groups:
KX-826 2.5 mg (0.25% concentration) twice daily.
KX-826 5 mg (0.5% concentration) once daily.
KX-826 5 mg (0.5% concentration) twice daily.
Placebo.
The overall safety profile of KX-826 was good per these results. No serious adverse event (SAE), adverse drug reaction (ADR), or death occurred. After 14 days of topical application, the blood concentration of KX-826 was very low in all dose groups.
Kintor says that it will accelerate the clinical progress of KX-826 and GT20029 in order to:
“Bring more innovative and effective treatment options to the hundreds of millions of people suffering from AGA and acne vulgaris worldwide.”
Update: August 11, 2022
Pyrilutamide Phase 2 Clinical Trial Results
Great news per a Chinese contact. It looks like Kintor may finally present the results of its Phase 2 Chinese trials of Pyrilutamide (KX-826) for hair loss on September 3 at 8:20 pm . The presenter will be Dr. Zhou Cheng from Peking University People’s Hospital (where Kintor’s Phase 3 trials are also being conducted right now).
Note that Kintor is not named in the presentation. However, I noticed that the chairman of this group of presenters (from Peking University) is Dr. Zhang Jianzhong. This man is listed in Kintor’s press releases as the principal investigator. So I decided to update this post as it looks believable now after months of waiting and delays.
The possible presentation (after translation) is titled: “New progress in diagnosis and treatment of androgenetic alopecia.” Please note that this KX-826 androgen receptor antagonist product is unlikely to bring back long lost hair in totally bad areas of the scalp. All I am hoping for is something as good as Dutasteride, but with a different mechanism of action.
Kintor Pharma presentation of Phase 2 clinical trials results will occur on September 3 in China at a Dermatology conference.
Kintor Pharmaceutical Update: Three Clinical Trials
Update: August 9, 2022 — Kintor just completed enrollment of 92 subjects in China for Phase 1 trials of its GT20029 hair loss product. This proprietary Proteolysis Targeting Chimera (AR-PROTAC) product is the world’s first topical androgen receptor degrader compound to enter clinical trials. They will test a gel or tincture per the press release, and results will be finalized at the end of 2022.
Update: August 3, 2022 — Kintor just completed patient enrollment of 121 subjects in its Phase 2 clinical trials of KX-826 (pyrilutamide) in the US. This topical androgen receptor antagonist product will be used to treat androgenetic alopecia.
Update: July 2022 — The China Phase 2 trial results for pyrilutamide for hair loss will occur at the postponed 28th Annual Meeting of the Chinese Society of Dermatology. It runs from August 31-September 4, 2022 in Shenyang.
Updates in April 2022
Some very unique updates in our Kintor channel in the hair loss chat this past week.
Kintor will present the results of its Phase 2 clinical trials (of KX-826, aka Pyrilutamide) for androgenetic alopecia at a “high-profile symposium” in June 2022.
Some people managed to view a classified Phase 2 results slide that concluded Pyrilutamide’s hair growth effect to be similar to Dutasteride. This would be amazing if true, since Pyrilutamide (targets the AR receptor) is totally different from Dutasteride (targets DHT). Anecdotal reports for now, but seem to be causing a lot of excitement.
A number of people are starting to report their results from using KX-826 via a Group Buy. I cannot encourage such experimental behavior, but I am following the reports keenly. Here is one I found on Reddit. Best of luck to these pioneers.
Kintor will Start Phase III Trials in China in January 2022
In the latest update from today (November 24th, 2021), Kintor Pharmaceutical announced that it will begin Phase 3 trials in China in January 2022! Update: Now begun.
The company’s IND application for the pivotal study (phase III) of pyrilutamide (KX-826) was cleared by China’s National Medical Products Administration. KX-826 is the first androgen receptor (AR) antagonist to enter phase III clinical trials anywhere in the world.
This is perhaps the best news in the hair loss world so far in 2021.
Update: November 12, 2021 — Kintor Pharma just started Phase II clinical trials in women in China with a first dose of pyrilutamide (KX-826). This trial pertains to androgenetic alopecia in women (i.e., female pattern hair loss).
Update: September 8, 2021 — Kintor Pharma just announced that its Phase II clinical study for KX-826 to treat androgenetic alopecia was a success. Primary endpoint was met. More detailed results will be released later per CEO Dr. Youzhi Tong. Phase III clinical trials in China will commence in the fourth quarter of 2021. Even better, Phase II trials are also currently taking place in the US. And Phase II trials for women will take place in China
Update: July 11, 2021 — The US FDA just approved Kintor’s Phase II clinical trial for pyrilutamide (KX-826) to treat androgenetic alopecia. Note that the company’s trials in China are already mid-way through Phase II per their pipeline page.
They area also working on another hair loss product named GT200029 that is an “AR-PROTAC” compound. Its Phase 1 trials will start in China this month.
April 15, 2021
Kintor Pharma: AR Antagonist and AR Degrader
Earlier today, it was announced that Kintor received approval in China to begin clinical trials for GT20029. This product will be in tincture or gel format, and will be tested for the treatment of androgenetic alopecia and acne.
The GT20029 product is an androgen receptor degrader (AR Degrader). It is developed using Kintor’s proprietary Proteolysis Targeting Chimera (PROTAC) platform. According to the press release, 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.
Note that Kintor’s main product for treating male pattern hair loss is KX-826 (Pyrilutamide) and is an androgen receptor antagonist (AR Antagonist). I covered the latter in prior updates to this post if you read till the end. KX-826 is currently in Phase 2 clinical trials in China and in Phase 1 trials in the US.
Note that Cassiopea’s Breezula (Clascoterone) is an AR antagonist that is well ahead of KX-826 when it comes to clinical trial stage. Kintor’s website has a very interesting article discussing both AR antagonist products and hair loss in China in general.
Kintor’s investigational new drug (IND) application of GT20029 for androgenetic alopecia and acne vulgaris was accepted by the National Medical Products Administration (NMPA) of China.
Kintor has moved forward with its trials faster than any other hair loss company. I am glad to see a Chinese company finally entering the hair loss cure market. Scientific and technological progress seem to happen faster in China than in the west. Hopefully, clinical trials for hair loss products will follow the same pattern.
Side note: In July 2020, Kintor and Applied Biology (US) collaborated on using Proxalutamide for the Treatment of COVID-19. There is a school of thought that suggests anti-androgens could help reduce Coronavirus fatalities. To date, more men have died from the disease then have women.
Kintor Pharmaceutical (China) also recently completed the enrollment of 120 patients in its Phase II clinical trials for pyrilutamide for hair loss. See the bottom half of this post for my original discussion on Kintor. Their stock is traded on the Hong Kong Hang Seng Index.
Key quote from CEO Dr. Youzhi Tong:
“We will accelerate the progress of its phase II/III clinical study so as to bring benefits to the people suffering from alopecia as soon as possible.”
May 26, 2020
A new Chinese company named Kintor Pharmaceutical is working on an interesting hair loss drug called pyrilutamide . It is extremely rare to hear about any Chinese company involved in hair loss cure research. Very strange, considering the country’s rapid pace of scientific advancement and massive population. Moreover, Chinese men and women are nowadays balding at much faster rates than in the past.
Four days ago, China-based Kintor Pharmaceutical (also known as Suzhou Kintor Pharmaceuticals) got significant Chinese media coverage. This interest was related to the company’s prostate cancer, breast cancer and hair loss drugs.
Earlier this month, Kintor Pharmaceutical also had a very successful IPO in Hong Kong.
While the company’s main focus seems to be its prostate cancer and breast cancer drugs, its androgenetic alopecia drug trials are also advancing rapidly. Their main androgen receptor blocking drug candidate is called Pyrilutamide (KX-826) and it is applied to the scalp topically. The company’s Proxalutamide drug slows or stops cancer cell growth by entirely inhibiting androgens.
Pyrilutamide
The one disappointing news is that Kintor aims to take on Johnson & Johnson’s Minoxidil. This could mean that topical Pyrilutamide is unlikely to be much better than Minoxidil. I hope I am wrong. Recently completed phase one trials in China proved that pyrilutamide is safe and causes no major side effects in humans.
Kintor is currently conducting phase 2 clinical trials for pyrilutamide on 160 men in China, and phase 1 trials on 30 men in the US. Phase 3 trials on 600 people in China, the US and Japan are planned for as soon as 2021. I would guess that the US FDA and Japanese PMDA will never accept Phase 2 results from China as any kind of proof to proceed to Phase 3 trials in the US and Japan.
So how can the company proceed so fast in the US and Japan?
