Kintor’s KX-826 Succeeds in Phase III Alopecia Trial – China NDA Filing Imminent

Kintor Pharmaceutical Ltd. Has announced positive results from a pivotal phase III clinical trial evaluating pyrilutamide (KX-826) as a treatment for male androgenetic alopecia (AGA), commonly known as male pattern baldness. The company intends to submit a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) following the demonstration of the primary endpoint in the trial. The phase III, randomized, double-blinded, placebo-controlled, multi-regional study involved 416 patients across more than 20 hospitals in China, with principal investigators including Professor Zhang Jianzhong from Peking University People’s Hospital and Director Yang Qinping from Huashan Hospital of Fudan University. The trial assessed the efficacy and safety of KX-826 over a 24-week period, with the primary endpoint being the change from baseline in non-vellus target area hair count (TAHC) at week 24. KX-826 is an androgen receptor (AR) antagonist, representing a novel approach to AGA treatment in China. It is the first AR antagonist to enter a phase III clinical trial for AGA in both China and globally. Previous phase II clinical trials in China demonstrated an “outstanding efficacy and safety profile” for KX-826, according to a prior announcement from the company. Kintor Pharma initially received IND clearance from the NMPA for the pivotal study on November 24, 2021. Patient enrollment began in early January 2022, and the company announced completion of subject enrollment on March 28, 2023. The drug is also being investigated for the treatment of acne vulgaris. Kintor Pharma expects to file the NDA with the NMPA in the near future.