Kintor Pharma gets clearance for Pyrilutamide to treat male Alopecia patients
New Delhi: Kintor Pharmaceutical Limited, a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that the IND application for the pivotal study (phase III stage) of pyrilutamide (KX-826), a potential first-in-class drug developed by Kintor Pharma, for the treatment of male androgenetic alopecia ("AGA") patients was cleared by the National Medical Products Administration ("NMPA").
KX-826 is the first androgen receptor (AR) antagonist which has entered the phase III clinical trial for AGA treatment in China and global.
The pivotal study is a randomized, double-blinded, placebo-controlled, multi-regional phase III clinical trial, which is designed to evaluate the efficacy and safety of KX-826 for treating male AGA patients in China. The sample size of the phase III clinical trial is 416 and the trial duration is 24 weeks. The primary endpoint is the change from baseline in non-vellus target area hair count (TAHC) at the end of week 24.
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