Pyrilutamide

Binds the androgen receptor in the scalp so DHT can't act on the follicle. Applied topically, the intent is to avoid the systemic side effects that make oral antiandrogens a hard sell; Kintor's 2024 reformulation aimed at higher retention in the scalp.

Among the most advanced of the new topical antiandrogens, alongside clascoterone. In March 2026 Kintor announced that the Phase III stage of its Chinese adaptive trial of the 1.0% formulation had met its primary endpoint, a gain of 10.65 hairs/cm² over placebo in 666 patients. The history behind that number matters: the earlier Chinese Phase III of the 0.5% formulation reported in November 2023 no statistically significant difference from placebo, while the US Phase 2 had met its endpoint at 0.5% twice daily, and Kintor moved to a higher-retention 1.0% formulation in response. A drug that works in one trial and not another usually has a dosing or delivery problem rather than a mechanism problem, which is the reading the sponsor's own reformulation implies. Kintor says it will start the NMPA submission in China in the near term; this register will move the row to filed when that is confirmed.

1. December 2021
   Phase 2→Phase 3

   First Phase 3 trial on record: NCT06126965 — Phase III Study of KX-826 With Adult Male Patients With AGA

   ClinicalTrials.gov ↗
2. September 2020
   Phase 1→Phase 2

   First Phase 2 trial on record: NCT05940506 — Phase II Study Evaluating the Efficacy and Safety of KX-826

   ClinicalTrials.gov ↗
3. January 2019
   Phase 1

   First Phase 1 trial on record: NCT04984707 — Safety, Tolerability and Pharmacokinetics of KX826 in Healthy Male Subjects With Androgenetic Alopecia Following Topical Single Ascending Dose Administration

   ClinicalTrials.gov ↗

• NCT06622824Phase 2/3Not yet recruiting

  To Evaluate Efficacy and Safety of TopicalKX-826 Solution in Chinese Male Patients With Androgenetic Alopecia

  Suzhou Kintor Pharmaceutical Inc, · n=756 · October 2024

• NCT05218642Phase 2Completed

  To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia

  Suzhou Kintor Pharmaceutical Inc, · n=123 · January 2022

• NCT06126965Phase 3Status unknown

  Phase III Study of KX-826 With Adult Male Patients With AGA

  Suzhou Kintor Pharmaceutical Inc, · n=740 · December 2021

• NCT06409650Phase 2Completed

  To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia

  Suzhou Koshine Biomedica, Inc. · n=160 · November 2021

• NCT05940506Phase 2Completed

  Phase II Study Evaluating the Efficacy and Safety of KX-826

  Suzhou Kintor Pharmaceutical Inc, · n=120 · September 2020

• NCT04502901Phase 1Completed

  the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending

  Suzhou Kintor Pharmaceutical Inc, · n=40 · January 2020

• NCT04984707Phase 1Completed

  Safety, Tolerability and Pharmacokinetics of KX826 in Healthy Male Subjects With Androgenetic Alopecia Following Topical Single Ascending Dose Administration

  Suzhou Kintor Pharmaceutical Inc, · n=40 · January 2019

Listing a trial is not a recommendation to join one. Eligibility, risks and costs vary enormously — discuss any trial with your own doctor first.

• Phase III KX-826 tincture 1.0% for AGA reached primary endpoint — Company release, March 2026
• Long-term safety Phase III trial of KX-826 for AGA reached primary endpoint — Company release, March 2025
• Kintor: Phase II/III adaptive trial of KX-826 1.0% tincture, higher-retention formulation — Company release, December 2024
• Kintor Pharmaceutical inside-information announcement: Phase III of KX-826 0.5% tincture did not reach statistical significance versus placebo — Regulator filing, November 2023
• Kintor's KX-826 meets primary endpoint in US Phase 2 androgenetic alopecia trial — Press, May 2023

Other programmes in the register with the same mechanism: Androgen receptor.

• Clascoterone (Breezula)Phase 3Cosmo Pharmaceuticals
• GT20029Phase 2Kintor Pharmaceutical