KX-826 Completes Phase III Trial in Men: What It Means for the Future of Hair Regrowth
Introduction
Another major milestone has been reached in the development of KX-826 (Pyrilutamide), the breakthrough topical treatment for pattern hair loss. Kintor Pharmaceuticals has officially completed its Phase III clinical trial in China for male patients with androgenetic alopecia (AGA). This is one of the most advanced studies ever conducted on a non-hormonal topical hair loss solution — and the results could shape the future of hair regrowth.
What Happened?
On March 28, 2023, Kintor announced that it had completed the last patient visit in its pivotal Phase III trial of KX-826 for adult males in China.
- Trial type: Multicenter, randomized, double-blind, placebo-controlled
- Participants: 416 men with AGA
- Study duration: 24 weeks
- Next step: Data analysis, followed by potential submission for market approval in China
Why This Is a Major Moment
✅ This is the first Phase III trial globally for a topical androgen receptor antagonist (ARA) targeting hair loss.
✅ KX-826 may soon become the first drug of its class to receive regulatory approval in any country.
✅ It marks a turning point in the move away from hormonal and oral-only treatments for male pattern baldness.
What Makes KX-826 Unique?
KX-826 is designed to be applied directly to the scalp and works by blocking androgen receptors locally. This approach helps reduce the miniaturization of hair follicles caused by DHT — without interfering with systemic hormones.
Unlike treatments like finasteride (which alters testosterone conversion), KX-826:
- Is non-hormonal
- Absorbs quickly via mist application
- Targets thinning at the scalp, not throughout the body
What’s Next?
Kintor will now move into final data review and reporting. If results from the Phase III trial confirm earlier Phase II findings (which showed a +22.73 hairs/cm² increase in density), KX-826 could be submitted for approval in China as early as this year.
Pending successful data, this could open the door to broader international availability, including the U.S. and European markets.
What It Means for Regenvia Customers
Regenvia is proud to offer one of the first consumer-accessible formulations powered by KX-826. While regulatory timelines continue, our commitment to science, safety, and transparency means you can experience the future of hair care — now.
Click here to read more on Kintor Pharmaceutical's announcement.