By Fineline Cube 
China-based Kintor Pharmaceutical (HKG: 9939) announced on July 24, 2025, that its self-developed 1.0% KX-826 topical solution has achieved its primary endpoint in a pivotal Phase II clinical trial for the treatment of androgenetic alopecia (AGA) in adult Chinese males. The results demonstrated both statistical significance and clinical relevance, alongside good safety and tolerability.
Clinical Trial Design and Results
This adaptive Phase II/III trial was a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of KX-826 topical solution at 0.5% and 1.0% concentrations. The Phase II stage enrolled 90 subjects who underwent a 24-week treatment period followed by a one-month safety observation. Results showed that both the 0.5% and 1.0% groups achieved statistically significant improvements in key efficacy indicators, including Target Area Hair Count (TAHC) and Investigator Global Assessment of Hair Growth (HGA), compared to the placebo group. Specifically, the 0.5% BID group saw a TAHC increase of 13.66 hairs/cm², while the 1.0% BID group increased by 13.14 hairs/cm². Both groups also showed clear superiority over placebo in HGA.
Safety Profile
Regarding safety, KX-826 exhibited a low incidence of overall adverse events, with no drug-related sexual dysfunction or new safety signals observed. This underscores the favorable safety and tolerability profile of the drug.
Future Trial Plans
The independent data monitoring committee (IDMC) recommended proceeding with the Phase III stage as originally designed. KX-826 is a potential first-in-class topical AR antagonist.-Fineline Info & Tech