Kintor Pharmaceutical Limited announced the first patient dosing in its phase II clinical trial of KX-826("pyrilutamide") in China for the treatment of acne vulgaris. The clinical trial in China for the treatment of acne vulgaris was the fusion design of phase I and phase II clinical trials. The phase II clinical trial is a randomized, double-blind, placebo-controlled, multi-regional clinical study to evaluate the safety and efficacy of KX-826 (gel) in patients with mild to moderate acne vulgaris.

The phase II sample size is 160, and the trial duration is 12 weeks. The primary endpoint is the treatment success rate (based on the Investigator Global Assessment —IGA score) at the end of week 12. This phase II clinical trial will be carried out in 6 medical institutions across China, with Professor Xiang Leihong from Huashan Hospital affiliated to Fudan University as the leading principal investigator (leading PI).

KX-826 is an androgen receptor (AR) antagonist and apotential first-in-class topical drug for the treatment of androgenetic alopecia (AGA) and acne vulgaris. For the acne vulgaris indication, KX-826, a topical AR antagonist with a specific target, can inhibit the combination of androgen receptor and androgenin hair follicle sebaceous glands, thereby treating acne vulgaris.