Kaiyuanluo Group: KX-826 Tincture Phase III Clinical Trial Meets Primary Endpoint

LightningPacketLoss · 2026-03-22T21:06:57+00:00

Kaituо Pharmaceuticals announced that its independently developed KX-826 tincture 1.0% achieved significant results in Phase III clinical trials for treating male androgenetic alopecia. The trial involved 666 patients, with the 1.0% BID group demonstrating notably superior efficacy compared to the placebo group. The company plans to submit a marketing application to regulatory authorities, aiming to become the first approved hair loss treatment drug.

LightningPacketLoss

2026-03-22 21:06:57

Abstract generation in progress

Recently, Kintor Pharmaceutical announced that the top-line data from its Phase III clinical trial of KX-826 1.0% topical solution for treating androgenetic alopecia in adult Chinese men has been obtained, and the trial has met its primary endpoint with statistically significant and clinically meaningful results.

The trial was conducted at 26 clinical research centers across the country, enrolling 666 patients, with 24 weeks of treatment and 14 days of safety observation. In terms of efficacy, the target area vellus hair count increased by 15.33 hairs/cm2 in the 1.0% BID group, 14.46 hairs/cm2 in the 0.5% BID group, while the placebo group only increased by 4.68 hairs/cm2. Compared to the placebo, the 1.0% BID group showed an increase of 10.65 hairs/cm2, with statistically significant results (P<0.0001). Regarding safety, no serious adverse events related to the drug occurred in any group, and the incidence of adverse events showed no significant difference.

The company plans to submit a marketing authorization application for KX-826 1.0% to Chinese regulatory authorities soon, noting that a topical innovative drug targeting the same mechanism is also in the process of application. Kintor aims to make KX-826 the first domestically and globally approved drug for hair loss treatment in its class.

(Kintor Pharmaceutical Announcement)

(Edited by: Yang Yan, Lin Chen)

Keywords: Medical

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