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Completion Of Patient Enrollment In Phase III Stage Of Pivotal Clinical Trial Of KX-826 Tincture 1.0% For The Treatment Of Male Adult AGA In China

Release time：2025-07-31 17:30

Suzhou, 31 July, 2025-Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), announced that the enrollment of 666 patients has been completed for the Phase III Stage of the  Pivotal Clinical Trial of its in-house developed and potential first-in-class KX-826 tincture 1.0%  for the treatment of AGA. The Pivotal Clinical Trial adopts a phase II/III operational seamless  design, and the phase II stage has reached its primary endpoint with statistically significant  and clinically meaningful outcomes, demonstrating excellent efficacy and safety.

 

The Pivotal Clinical Trial is a multi-center, randomized, double-blind, vehicle controlled phase II/III study with adaptive designs to evaluate the efficacy and safety of KX-826 tincture 1.0% and 0.5% for the topical treatment of male adults with AGA in China. The Phase III  Stage involved 25 clinical research centers in China and a 24-week treatment period at the  prescribed dosages, followed by a 2-week safety observation period. The Phase III Stage is expected to be completed by the beginning of 2026. 

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Phase II Stage Of Pivotal Clinical Trial Of KX-826 Tincture 1.0% For The Treatment Of Male Adult AGA In China Reached Primary Endpoint

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