{"id":2797,"date":"2026-06-16T09:40:30","date_gmt":"2026-06-16T09:40:30","guid":{"rendered":"https:\/\/drsoniafawad.com\/?p=2797"},"modified":"2026-06-16T09:40:30","modified_gmt":"2026-06-16T09:40:30","slug":"kintor-pharmaceutical-phase-3-trial-results-for-kx-826-and-gt20029","status":"publish","type":"post","link":"https:\/\/drsoniafawad.com\/?p=2797","title":{"rendered":"Kintor Pharmaceutical Phase 3 Trial Results for KX-826 and GT20029"},"content":{"rendered":"<p><br \/>\n<\/p>\n<div>\n<p><strong><span style=\"color: red;\">All the latest updates are underneath the below introductory section on KX-826 and GT20029.<\/span><\/strong><\/p>\n<p>Note that Kintor is already selling its KX-826 (Pyrilutamide) androgen receptor antagonist (finishing Phase 3 trials in 2026) as a topical cosmetic on Amazon.<\/p>\n<figure id=\"attachment_20679\" aria-describedby=\"caption-attachment-20679\" style=\"width: 600px\" class=\"wp-caption alignnone\"><img fetchpriority=\"high\" fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-20679 size-full\" src=\"https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2023\/11\/Kintor-Pharma-Pyrilutamide-KX-826.jpg\" alt=\"Kintor Pharma Pyrilutamide (KX-826)\" width=\"600\" height=\"410\" srcset=\"https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2023\/11\/Kintor-Pharma-Pyrilutamide-KX-826.jpg 600w, https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2023\/11\/Kintor-Pharma-Pyrilutamide-KX-826-300x205.jpg 300w\" sizes=\"(max-width: 600px) 100vw, 600px\"\/><figcaption id=\"caption-attachment-20679\" class=\"wp-caption-text\">Kintor Pharmaceutical Pyrilutamide (KX-826) Androgen Receptor Antagonist.<\/figcaption><\/figure>\n<h2>Kintor Pharmaceutical: KX-826 and GT20029 for Androgenetic Alopecia<\/h2>\n<p>My <a href=\"https:\/\/www.hairlosscure2020.com\/kintor-pharmaceutical-from-china\/\" target=\"_blank\" rel=\"noopener\">original post<\/a> on Kintor Pharmaceutical (China) has become way too lengthy after so many updates. I will now add all new updates in this post below this section.<\/p>\n<p>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 (<a href=\"https:\/\/en.kintor.com.cn\/about\/1.html\" target=\"_blank\" rel=\"noopener\">pipeline here<\/a>) is conducting hair loss trials for:<\/p>\n<ul>\n<li>Two separate androgen receptor (AR) targeting products: a degrader (GT20029) and an antagonist (<a href=\"https:\/\/anageninc.com\/product\/pyrilutamide-kx-826\/\" target=\"_blank\" rel=\"noopener\">KX-826 aka Pyrilutamide<\/a>).<\/li>\n<li>Each of these trials is being conducted in both China and the US.<\/li>\n<li>Each of these products is being tested for both males and females with androgenetic alopecia (aka pattern hair loss).<\/li>\n<\/ul>\n<p>i.e., a total of 8 types of clinical trials times 3 phases in each = <strong>24 developments<\/strong> 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.<\/p>\n<ul>\n<li style=\"margin-bottom: 10px;\">The GT20029 product is an androgen receptor degrader (<span style=\"color: blue;\"><strong>AR Degrader<\/strong><\/span>). It is developed using Kintor\u2019s proprietary Proteolysis Targeting Chimera (PROTAC) platform. This is the world\u2019s first topical androgen receptor (AR) compound (AR-PROTAC) to enter clinical trials. GT20029 degrades the AR protein via the <em>E3 ubiquitin ligase<\/em>\u00a0pathway. During preclinical studies, GT20029 did not cause any notable side effects or systemic drug accumulation.<\/li>\n<li>Kintor\u2019s main product for treating male pattern hair loss is KX-826 (Pyrilutamide) and is an androgen receptor antagonist (<span style=\"color: red;\"><strong>AR Antagonist<\/strong><\/span>). KX-826 is currently in Phase 3 clinical trials in the US and has completed Phase 3 trials in China.<\/li>\n<\/ul>\n<p>Note that\u00a0Cassiopea\u2019s <a href=\"https:\/\/www.hairlosscure2020.com\/category\/breezula\/\" target=\"_blank\" rel=\"noopener\">Breezula<\/a> (Clascoterone) is an AR antagonist that is also currently in Phase 3 trials in the US. Kintor\u2019s website has an interesting article discussing both these competing AR antagonist products and hair loss. Make sure to also read my related past post on\u00a0<a href=\"https:\/\/www.hairlosscure2020.com\/destroying-androgen-receptors-on-the-scalp\/\" target=\"_blank\" rel=\"noopener\">destroying the androgen receptor<\/a>\u00a0to reverse hair loss.<\/p>\n<figure id=\"attachment_21784\" aria-describedby=\"caption-attachment-21784\" style=\"width: 500px\" class=\"wp-caption alignnone\"><img decoding=\"async\" class=\"size-full wp-image-21784\" src=\"https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2024\/04\/Kintor-GT20029.webp\" alt=\"Kintor GT20029 Androgen Receptor Degrader.\" width=\"500\" height=\"470\" srcset=\"https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2024\/04\/Kintor-GT20029.webp 500w, https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2024\/04\/Kintor-GT20029-300x282.webp 300w\" sizes=\"(max-width: 500px) 100vw, 500px\"\/><img decoding=\"async\" class=\"lazyload size-full wp-image-21784\" src=\"https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2024\/04\/Kintor-GT20029.webp\" alt=\"Kintor GT20029 Androgen Receptor Degrader.\" width=\"500\" height=\"470\" srcset=\"https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2024\/04\/Kintor-GT20029.webp 500w, https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2024\/04\/Kintor-GT20029-300x282.webp 300w\" data-sizes=\"(max-width: 500px) 100vw, 500px\"\/><figcaption id=\"caption-attachment-21784\" class=\"wp-caption-text\">Kintor GT20029 Androgen Receptor Degrader.<\/figcaption><\/figure>\n<p><strong><span style=\"color: blue;\">Update: June 2, 2026<\/span><\/strong><\/p>\n<h3>KX-826 Phase 3 Results Positive and Approval is Likely<\/h3>\n<p>Kintor made a poster presentation at last week\u2019s WCHR Conference that was well received and received an award.<\/p>\n<p>Professor Cheng Zhou from Peking University People\u2019s Hospital (the lead principal investigators of the phase III clinical trial), presented the final results of KX-826 1.0% tincture. The treatment group consisted of male Chinese adults with androgenetic alopecia. On their site, they released <a href=\"https:\/\/en.kintor.com.cn\/news_details\/23.html\" target=\"_blank\" rel=\"noopener\">an encouraging summary<\/a> of the results, with the following quote:<\/p>\n<blockquote>\n<p><span style=\"color: blue;\">\u201cThe overall results demonstrated that KX-826 exhibited excellent efficacy and safety in patients with AGA.\u201d<\/span><\/p>\n<\/blockquote>\n<p>Kintor is now actively pursuing the marketing authorization for KX-826. Upon approval, KX-826 is expected to become <strong>the first new treatment for male pattern hair loss in 30 years<\/strong>. Minoxidil was approved to treat androgenetic alopecia in 1988; and finasteride was approved for the same purpose in 1997.<\/p>\n<p><span style=\"color: blue;\">Update: March 18, 2026<\/span><\/p>\n<h3>KX-826 1.0% Phase 3 Trial Primary Endpoint Results<\/h3>\n<p>Kintor <a href=\"https:\/\/en.kintor.com.cn\/news_details\/22.html\" target=\"_blank\" rel=\"noopener\">just announced<\/a> that the Phase 3 stage of the company\u2019s pivotal clinical trial for its KX-826 tincture 1.0% for the treatment of AGA has obtained top-line results. The numbers show statistically significant and clinically meaningful hair growth outcomes, while demonstrating excellent efficacy and safety. A total of 666 patients were treated for 24 weeks.<\/p>\n<p>Both the 1.0% BID (i.e. twice a day) group and 0.5% BID group demonstrated statistically significant therapeutic efficacy and clinical significance relative to the placebo group. The target area non-vellus hair counts (\u201cTAHC\u201d) of the 1.0% BID group showed an increase of 15.33 hairs\/cm<sup>2<\/sup> from baseline. The TAHC of the 0.5% BID group showed an increase of 14.46 hairs\/cm<sup>2<\/sup> from baseline. The TAHC of the placebo group showed an increase of 4.68 hairs\/cm<sup>2<\/sup> from baseline.<\/p>\n<p>Note that at the bottom of the press release, they basically imply that competing product Breezula will beat them to market in the US and EU.<\/p>\n<p><span style=\"color: blue;\">Update: December 3, 2025<\/span><\/p>\n<h3>Positive Phase 2 Trial Results for GT20029<\/h3>\n<p>In my April 2024 update, I discussed the positive interim results for the Phase 2 clinical trial of GT20029 in China. Now we have <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/41328006\/\" target=\"_blank\" rel=\"noopener\">a final report<\/a> published on PubMed. The randomized, double-blind, placebo-controlled Phase II trial entailed 180 Chinese adult males with androgenetic alopecia. It lasted from April 2023 to April 2024. The subjects were randomized equally into six groups receiving GT20029 (0.5% or 1.0%) or placebo, either once daily (QD) or twice weekly (BIW) for 12 weeks. All four GT20029-treated groups showed significant increases in target area hair count (TAHC) at Week 12. Target area hair width (TAHW) also improved significantly in the 1.0% BIW group vs placebo.<\/p>\n<p><span style=\"color: blue;\">Update: September 25, 2025<\/span><\/p>\n<p>Check out the <a href=\"https:\/\/old.reddit.com\/r\/Koshine826\/comments\/1nqautu\/kintors_ama_active_now_september_25_from_1200200\/\" target=\"_blank\" rel=\"noopener\">Kintor AMA<\/a> on Reddit with one of their medical scientists.<\/p>\n<p><span style=\"color: blue;\">Update: August 1, 2025<\/span><\/p>\n<h3>KX-826 1.0% Phase 3 Trials to Finish in Early 2026<\/h3>\n<p>Kintor\u2019s <a href=\"https:\/\/en.kintor.com.cn\/news_details\/16.html\" target=\"_blank\" rel=\"noopener\">enrollment<\/a> of 666 patients in the Phase III Pivotal Clinical Trial of KX-826 tincture 1.0% for the treatment of AGA is finished. This trial is expected to be completed by the beginning of 2026.<\/p>\n<p><span style=\"color: blue;\">Update: July 25, 2025<\/span><\/p>\n<h3>KX-826 1.0% versus KX-826 0.5%<\/h3>\n<p>Among the numerous trials that Kintor is undertaking for its two androgen receptor targeting products is a Phase II\/III trial for KX-826 tincture 1.0% dosage. Yesterday, it <a href=\"https:\/\/en.kintor.com.cn\/news_details\/15.html\" target=\"_blank\" rel=\"noopener\">announced the results<\/a> of its \u201cPhase 2 stage\u201d of this pivotal trial consisting of 90 volunteers.<\/p>\n<ul>\n<li>The target area non-vellus hair counts (\u201cTAHC\u201d) of the 0.5% BID group increased by 22.39 hairs\/cm<sup>2<\/sup> from baseline.<\/li>\n<li>The TAHC of the 1.0% BID group increased by 21.87 hairs\/cm<sup>2<\/sup> from baseline.<\/li>\n<li>The TAHC of the placebo group increased by 8.73 hairs\/cm<sup>2<\/sup> from baseline.<\/li>\n<\/ul>\n<p>So the 0.5% and 1.0% dosages seem equally effective. A bit disappointing.<\/p>\n<p><span style=\"color: blue;\">Update: May 2, 2025<\/span><\/p>\n<h4>Clinical Observational Study finds KX-826 plus Minoxidil to be Superior<\/h4>\n<p>Kintor just published the <a href=\"https:\/\/en.kintor.com.cn\/news_details\/10.html\" target=\"_blank\" rel=\"noopener\">primary endpoint results<\/a> of its observational study on using KX-826 in combination with Minoxidil. Key quote:<\/p>\n<blockquote>\n<p>\u201cAfter 24 weeks of treatment, the TAHC of the Combination Drugs Group showed an increase of 30.54 hairs\/cm2 from baseline. This was 10.29 hairs\/cm2 more than the Minoxidil Group,\u201d<\/p>\n<\/blockquote>\n<p>A total of 40 Chinese patients took KX-826 tincture 0.5% BID (i.e. twice per day) plus minoxidil tincture 5% BID in the combination group. The Minoxidil only group had 35 participants. All 75 enrollees suffered from androgenetic alopecia. Interestingly, at week 24, there were 11 patients with TAHC change from baseline \u226540 hairs\/cm\u00b2. Of these, 10 patients were in the Combination Drugs Group.<\/p>\n<p>To me, these results are as expected when compared to the Phase 3 results of KX-826 by itself that I wrote about in the March 21, 2025 update.<\/p>\n<p><span style=\"color: blue;\">Update: April 29, 2025<\/span><\/p>\n<h2>Kintor KX-826 to get Released in China in 2027<\/h2>\n<p>Kintor\u2019s <a href=\"https:\/\/staticpacific.blob.core.windows.net\/press-releases-attachments\/3558273\/HKEX-EPS_20250429_11653395_0.PDF\" target=\"_blank\" rel=\"noopener\">Annual Report for 2024<\/a> was released yesterday (h\/t \u201cRex\u201d). In regards to commercialization for KX-826, Kintor expects to submit a NDA to the Chinese NMPA in 2026. If the application is successful, commercialization of KX-826 in China is expected in 2027. They have updated their <a href=\"https:\/\/en.kintor.com.cn\/about\/1.html\" target=\"_blank\" rel=\"noopener\">pipeline page<\/a>, which includes trials for both KX-826 and GT20029 in China and the US.<\/p>\n<p><span style=\"color: blue;\">Update: March 21, 2025<\/span><\/p>\n<h3>Phase III Clinical Trial Of KX-826 Reaches Primary Endpoint<\/h3>\n<p>Kintor Pharmaceutical<a href=\"https:\/\/en.kintor.com.cn\/news_details\/9.html\" target=\"_blank\" rel=\"noopener\"> just announced<\/a> that the long-term safety Phase III clinical trial of its first-in-class KX-826 (pyrilutamide) tincture for the treatment of androgenetic alopecia has reached its primary endpoint. The results are very good, the safety profile is excellent and therefore the company\u2019s stock price went up a stunning 51% so far today. The first person in this 52-week trial was enrolled on 19 July 2023. The results demonstrated excellent safety and efficacy. Key highlights:<\/p>\n<ol>\n<li style=\"list-style-type: none;\">\n<ol>\n<li>46% of patients saw a \u226510 hairs\/cm<sup>2<\/sup> change in total area hair count (TAHC) from baseline.<\/li>\n<li>20% of patients saw a \u226520 hairs\/cm<sup>2<\/sup> change in TAHC.<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<p>Note that this clinical trial involves a total of 16 clinical research centers in China. It seems like earlier \u201cpre\u201d primary endpoint positive results were also released last year (see my update from October 17, 2024).<\/p>\n<p>Even better news is that this trial used KX-826 tincture 0.5% BID (twice per day) as the dosage. Kintor also began a Phase III trial for the higher-dose 1.0% at the beginning of 2025. That dose might give even better results.<\/p>\n<p><span style=\"color: blue;\">Update January 28, 2025<\/span><\/p>\n<p>A <a href=\"https:\/\/www.youtube.com\/watch?v=RMNCqHsqDZg\" target=\"_blank\" rel=\"noopener\">lengthy and thorough interview<\/a> with scientists from Kintor Pharma.<\/p>\n<p><span style=\"color: blue;\">Update January 1, 2025<\/span><\/p>\n<h3>KX-826 (Pyrilutamide) 1.0% Phase III Trials<\/h3>\n<p>Kintor <a href=\"https:\/\/en.kintor.com.cn\/news_details\/6.html\" target=\"_blank\" rel=\"noopener\">has enrolled<\/a> its first subject in the Phase III pivotal clinical trial of its KX-826 tincture 1.0% in China for the treatment of male androgenetic alopecia. Note that the Phase III results for the 0.5% dosage were released in 2024 (see further below) and total area hair counts increase by around 10%, with results lasting even at 52 weeks.<\/p>\n<p>The 1.0% dosage will likely lead to even better results based on prior preclinical findings. Kintor plans to recruit 666 patients and complete the trials by the end of 2025.<\/p>\n<p><span style=\"color: blue;\">Update November 29, 2024<\/span><\/p>\n<p>Earlier this week, scientists from Kintor Pharmaceutical (and Koshine Medical) did <a href=\"https:\/\/www.reddit.com\/r\/Koshine826\/comments\/1gzktsq\/ama_with_kintorkoshine_medical_scientists_the\/\" target=\"_blank\" rel=\"noopener\">a Reddit AMA<\/a>. Some of the highlights:<\/p>\n<ul>\n<li>They are currently developing a 2% foam version of KX-826, though the timeline for its release is yet to be determined.<\/li>\n<li>Phase 3 trials for GT20029 are planned in China in 3Q 2025. US will be 6 months later. This is for the actual medication, and not for a cosmetic (for which such trials are not required).<\/li>\n<li>GT20029 has the potential \u201cto be revolutionary\u201d for AGA treatment. They have found that once-a-week dosing with GT20029 demonstrated similar efficacy to daily dosing. this is a significant advantage compared to the twice-a-day dosing required for treatments such as Minoxidil, CB-03-01 (Breezula), and KX-826 (Pyrilutamide).<\/li>\n<\/ul>\n<p><span style=\"color: blue;\">Update October 17, 2024<\/span><\/p>\n<h2>Kintor Releases Phase 3 Results for KX-826 at a 0.5% Dosage. Now they will Test 1.0%.<\/h2>\n<p>A <a href=\"https:\/\/www1.hkexnews.hk\/listedco\/listconews\/sehk\/2024\/1016\/2024101600423.pdf\" target=\"_blank\" rel=\"noopener\">new update<\/a> on KX-826 (Pyrilutamide) Phase 3 Trials from Kintor that is not yet on their website.<\/p>\n<ul>\n<li style=\"margin-bottom: 10px;\">They have completed the first subject enrollment in the pivotal Phase II\/III clinical trial of KX-826 tincture <strong>1.0%<\/strong> for the treatment of male adult androgenetic alopecia in China. The company\u2019s preclinical studies have shown that the KX-826 tincture 1.0% has a significantly higher retention rate in human scalp cells compared to the KX-826 tincture <strong>0.5%<\/strong>. and good chance at showing greater efficacy. The latter lower dose was used in the previous Phase III clinical trial (see next point).<\/li>\n<li style=\"margin-bottom: 10px;\">They also give results of the Chinese Phase III clinical trials for the 0.5% dosage. This trial entailed the use of KX-826 tincture 0.5% BID (twice per day) on 95 male patients for 52 weeks. There were no serious adverse events reported. In terms of efficacy, after 12, 24, 36 and 52 weeks of treatment, both total area hair count (TAHC) and target area non-vellus hair width (TAHW) showed an increase from baseline. <span style=\"color: blue;\">The TAHC increased by 9.5%, 13.0%, 11.4% and 9.7% respectively, while the TAHW increased by 12.1%, 18.6%, 15.7% and 10.0% respectively<\/span>. So the best results are at 24 weeks, though there is still significant positive growth at 52 weeks.<\/li>\n<\/ul>\n<p>Also check out my July 2024 post on <a href=\"https:\/\/www.hairlosscure2020.com\/kx-826-pyrilutamide-cosmetic-launched\/\" target=\"_blank\" rel=\"noopener\">KX-826 Hair Growth Spray Launched.<\/a><\/p>\n<p><span style=\"color: blue;\">Update: July 11, 2024<\/span><\/p>\n<h3>Kintor Launches Cosmetics with KX-826 as the Main Ingredient<\/h3>\n<p>Kintor Pharmaceutical <a href=\"https:\/\/en.kintor.com.cn\/news_details\/3.html\" target=\"_blank\" rel=\"noopener\">has officially launched<\/a> 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 <a href=\"https:\/\/www.hairlosscure2020.com\/cosmerna-for-hair-loss-from-sirnagen\/\" target=\"_blank\" rel=\"noopener\">CosmeRNA<\/a>).<\/p>\n<p><span style=\"color: blue;\">Update: June 5, 2024<\/span><\/p>\n<h3>KX-826 Receives The INCI Cosmetic Designation<\/h3>\n<p>Kintor Pharmaceutical\u2019s KX-826 (Pyrilutamide) <a href=\"https:\/\/en.kintor.com.cn\/news\/256.html\" target=\"_blank\" rel=\"noopener\">has received<\/a> the International Nomenclature Cosmetic Ingredient (INCI) approval from the International Cosmetic Ingredient Nomenclature Committee. The assigned INCI name is <em>Methylpyridinyl Fluoromethoxybenzonitrile Dimethyloxothiooxoimidazolidine<\/em>. INCI names are recognized worldwide when identifying cosmetic ingredients. This development will facilitate the potential future global launch of Kintor\u2019s line of cosmetics that have KX-826 as the main ingredient.<\/p>\n<p><span style=\"color: blue;\">Update: May 24, 2024<\/span><\/p>\n<h3>More Effective KX-826 Tincture 1.0% versus 0.5%<\/h3>\n<p>Kintor\u2019s clinical trial of KX-826 tincture 1.0% for treating male androgenetic alopecia in China <a href=\"https:\/\/en.kintor.com.cn\/news_details\/1803365120285716480.html\" target=\"_blank\" rel=\"noopener\">just received clearance<\/a>. The company\u2019s 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\u2019s previous phase III clinical trial.<\/p>\n<p><span style=\"color: blue;\">Update: April 22, 2024<\/span><\/p>\n<h3>Positive Update on GT20029 Phase 2 Clinical Trial<\/h3>\n<p>Kintor Pharmaceutical <a href=\"https:\/\/en.kintor.com.cn\/news_details\/1803365125008502784.html\" target=\"_blank\" rel=\"noopener\">just announced<\/a> 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 <a href=\"https:\/\/www.prnewswire.com\/news-releases\/gt20029-china-phase-ii-trial-for-aga-reached-primary-endpoint-302122889.html\" target=\"_blank\" rel=\"noopener\">primary endpoint<\/a>. The results are statistically significant and clinically meaningful, while safety and tolerability is good.<\/p>\n<p>GT20029 demonstrated statistically significant efficacy compared to placebo in both the QD (once a day) and BIW (twice a week) dosing cohorts.<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>After 12 weeks of treatment, the 0.5% QD GT20029 group showed an increase of 16.80 hairs\/cm\u00b2 from baseline. This was <span style=\"color: red;\">6.69 hairs\/cm\u00b2 more<\/span> than the placebo group.<\/li>\n<li>The total area hair count (TAHC) of GT20029 1.0% BIW group showed an increase of 11.94 hairs\/cm\u00b2 from baseline. This was <span style=\"color: red;\">7.36 hairs\/cm\u00b2 more<\/span> than the placebo.<\/li>\n<li>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.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>Key Quote:<\/p>\n<blockquote>\n<p><span style=\"color: blue;\">\u201cBased on the results of the Phase II clinical trial, the company will actively deploy subsequent clinical strategies for GT20029, such as <strong>initiating a phase III clinical trial in China<\/strong> and a phase II clinical trial in the US for male AGA.\u201d<\/span><\/p>\n<\/blockquote>\n<p><span style=\"color: blue;\">Update: February 1, 2024<\/span><\/p>\n<h4>Clinical Trial of KX-826 and Minoxidil<\/h4>\n<p>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.<\/p>\n<p>Now comes news that Kintor will also undertake Phase 1b\/III clinical trials of KX-826 <a href=\"https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2024\/02\/Kintor_KX-826_Minoxidil.pdf\" target=\"_blank\" rel=\"noopener\">in combination with minoxidil<\/a> for the treatment of androgenetic alopecia (AGA). The trial was just cleared by the National Medical Products Administration in China.<\/p>\n<p><span style=\"color: blue;\">Update: November 27, 2023<\/span><\/p>\n<h4>Bad News for KX-826 Phase 3 Trial Results?<\/h4>\n<p>According to <a href=\"https:\/\/www.reddit.com\/r\/tressless\/comments\/184pdh7\/kintor_has_released_an_investor_relations_memo\/\" target=\"_blank\" rel=\"noopener\">this Reddit source<\/a>, 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 \u201ctrend in efficacy observed\u201d.<\/p>\n<p>On a positive note, Kintor <strong>plans to continue<\/strong> 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. <strong>Edit:<\/strong> Seems like this never happened?<\/p>\n<p><span style=\"color: blue;\">November 18, 2023<\/span><\/p>\n<h3>Phase 3 Trials for KX-826 (Pyrilutamide)<\/h3>\n<p>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\u2019s 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.<\/p>\n<p>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.<\/p>\n<blockquote>\n<p>\u201cKX-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.<\/p>\n<p>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 <strong>22.73<\/strong> roots per square centimeter compared to baseline.<\/p>\n<p><span style=\"color: blue;\">Finally, news about Phase III: KX-826 is currently in or planned for <strong>five Phase III clinical trials<\/strong> (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 <strong>making full efforts<\/strong> to promote the data collation, library un-blinding and data statistical analysis of this clinical trial<\/span>.\u201d<\/p>\n<\/blockquote>\n<p><a href=\"https:\/\/ulo.co\/\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" class=\"alignnone wp-image-25470 size-full\" src=\"https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2025\/10\/Ulo-Personalized-Hair-Treatments.png\" alt=\"Ulo Personalized Hair Treatments\" width=\"600\" height=\"106\" srcset=\"https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2025\/10\/Ulo-Personalized-Hair-Treatments.png 600w, https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2025\/10\/Ulo-Personalized-Hair-Treatments-300x53.png 300w\" sizes=\"(max-width: 600px) 100vw, 600px\"\/><img loading=\"lazy\" decoding=\"async\" class=\"lazyload alignnone wp-image-25470 size-full\" src=\"https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2025\/10\/Ulo-Personalized-Hair-Treatments.png\" alt=\"Ulo Personalized Hair Treatments\" width=\"600\" height=\"106\" srcset=\"https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2025\/10\/Ulo-Personalized-Hair-Treatments.png 600w, https:\/\/www.hairlosscure2020.com\/wp-content\/uploads\/2025\/10\/Ulo-Personalized-Hair-Treatments-300x53.png 300w\" data-sizes=\"(max-width: 600px) 100vw, 600px\"\/><\/a><\/p>\n<\/div>\n<p><br \/>\n<br \/><a href=\"https:\/\/www.hairlosscure2020.com\/kintor-pharma-updates-on-kx-826-gt20029\/\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>All the latest updates are underneath the below introductory section on KX-826 and GT20029. Note that Kintor is already selling its KX-826 (Pyrilutamide) androgen receptor antagonist (finishing Phase 3 trials in 2026) as a topical cosmetic on Amazon. Kintor Pharmaceutical Pyrilutamide (KX-826) Androgen Receptor Antagonist. 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. I will now add all new updates in this post below this 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\u2019s proprietary Proteolysis Targeting Chimera (PROTAC) platform. This is the world\u2019s first topical androgen receptor (AR) compound (AR-PROTAC) to enter clinical trials. GT20029 degrades the AR protein via the E3 ubiquitin ligase\u00a0pathway. During preclinical studies, GT20029 did not cause any notable side effects or systemic drug accumulation. Kintor\u2019s 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 the US and has completed Phase 3 trials in China. Note that\u00a0Cassiopea\u2019s Breezula (Clascoterone) is an AR antagonist that is also currently in Phase 3 trials in the US. Kintor\u2019s website has an interesting article discussing both these competing AR antagonist products and hair loss. Make sure to also read my related past post on\u00a0destroying the androgen receptor\u00a0to reverse hair loss. Kintor GT20029 Androgen Receptor Degrader. Update: June 2, 2026 KX-826 Phase 3 Results Positive and Approval is Likely Kintor made a poster presentation at last week\u2019s WCHR Conference that was well received and received an award. Professor Cheng Zhou from Peking University People\u2019s Hospital (the lead principal investigators of the phase III clinical trial), presented the final results of KX-826 1.0% tincture. The treatment group consisted of male Chinese adults with androgenetic alopecia. On their site, they released an encouraging summary of the results, with the following quote: \u201cThe overall results demonstrated that KX-826 exhibited excellent efficacy and safety in patients with AGA.\u201d Kintor is now actively pursuing the marketing authorization for KX-826. Upon approval, KX-826 is expected to become the first new treatment for male pattern hair loss in 30 years. Minoxidil was approved to treat androgenetic alopecia in 1988; and finasteride was approved for the same purpose in 1997. Update: March 18, 2026 KX-826 1.0% Phase 3 Trial Primary Endpoint Results Kintor just announced that the Phase 3 stage of the company\u2019s pivotal clinical trial for its KX-826 tincture 1.0% for the treatment of AGA has obtained top-line results. The numbers show statistically significant and clinically meaningful hair growth outcomes, while demonstrating excellent efficacy and safety. A total of 666 patients were treated for 24 weeks. Both the 1.0% BID (i.e. twice a day) group and 0.5% BID group demonstrated statistically significant therapeutic efficacy and clinical significance relative to the placebo group. The target area non-vellus hair counts (\u201cTAHC\u201d) of the 1.0% BID group showed an increase of 15.33 hairs\/cm2 from baseline. The TAHC of the 0.5% BID group showed an increase of 14.46 hairs\/cm2 from baseline. The TAHC of the placebo group showed an increase of 4.68 hairs\/cm2 from baseline. Note that at the bottom of the press release, they basically imply that competing product Breezula will beat them to market in the US and EU. Update: December 3, 2025 Positive Phase 2 Trial Results for GT20029 In my April 2024 update, I discussed the positive interim results for the Phase 2 clinical trial of GT20029 in China. Now we have a final report published on PubMed. The randomized, double-blind, placebo-controlled Phase II trial entailed 180 Chinese adult males with androgenetic alopecia. It lasted from April 2023 to April 2024. The subjects were randomized equally into six groups receiving GT20029 (0.5% or 1.0%) or placebo, either once daily (QD) or twice weekly (BIW) for 12 weeks. All four GT20029-treated groups showed significant increases in target area hair count (TAHC) at Week 12. Target area hair width (TAHW) also improved significantly in the 1.0% BIW group vs placebo. Update: September 25, 2025 Check out the Kintor AMA on Reddit with one of their medical scientists. Update: August 1, 2025 KX-826 1.0% Phase 3 Trials to Finish in Early 2026 Kintor\u2019s enrollment of 666 patients in the Phase III Pivotal Clinical Trial of KX-826 tincture 1.0% for the treatment of AGA is finished. This trial is expected to be completed by the beginning of 2026. Update: July 25, 2025 KX-826 1.0% versus KX-826 0.5% Among the numerous trials that Kintor is undertaking for its two androgen receptor targeting products is a Phase II\/III trial for KX-826 tincture 1.0% dosage. Yesterday, it announced the results of its \u201cPhase 2 stage\u201d of this pivotal trial consisting of 90 volunteers. The target area non-vellus hair counts (\u201cTAHC\u201d) of the 0.5% BID group increased by 22.39 hairs\/cm2 from baseline. The TAHC of the 1.0% BID group increased by 21.87 hairs\/cm2 from baseline. The TAHC of the placebo group increased by 8.73 hairs\/cm2 from baseline. So the 0.5% and 1.0% dosages seem equally effective. A bit disappointing. Update: May 2, 2025 Clinical Observational Study finds KX-826 plus Minoxidil to be Superior Kintor just published the primary endpoint<\/p>\n","protected":false},"author":1,"featured_media":2798,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[],"class_list":["post-2797","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-hair-fall-dandruff"],"_links":{"self":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/posts\/2797","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2797"}],"version-history":[{"count":0,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/posts\/2797\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/media\/2798"}],"wp:attachment":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2797"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2797"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2797"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}