Kintor Pharmaceutical Announced FDA Has Greenlighted Pyrilutamide's Phase II Clinical Trial for Androgenetic Alopecia in the US

Kintor Pharmaceutical Limited, a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, announced that the U.S. Food and Drug Administration (FDA) has greenlighted pyrilutamide's phase II clinical trial for androgenetic alopecia(AGA) to be conducted in the US.

The phase II trial is a randomized, double-blind, vehicle-controlled, parallel group study,  designed to evaluate the efficacy and safety of pyrilutamide in male subjects with AGA. The primary endpoint for the trial is the change from baseline in non-vellus TAHC (Target Area Hair Counts) at Week 24 in comparison to vehicle.

Dr. Tong Youzhi, the founder, chairman, and CEO of Kintor Pharmaceutical, commented, "We are delighted to receive the clearance from the US FDA for this phase II clinical trial of pyrilutamide in AGA Subjects. This has been the fifth clinical study sponsored by Kintor in the US. The phase II clinical trial of pyrilutamide for the treatment of AGA in China is close to end, and we expect the data read-out in this quarter. We have adopted the strategy of conducting clinical trials both in China and the US , and wish pyrilutamide would benefit people suffering from AGA in China and global."

About Pyrilutamide (KX-826)

Pyrilutamide, a topical AR antagonist with a specific target, can inhibit the combination of androgen receptor and androgen in hair follicle sebaceous glands, thereby treating androgenetic alopecia and acne.

About Kintor Pharmaceutical Limited

Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia and acne.