Pelage Pharmaceuticals’ alopecia

Pelage Pharmaceuticals’ alopecia treatment moves forward to phase 3 trial

The news follows positive phase 2a results for the androgenetic alopecia treatment

Pelage Pharmaceuticals, a clinical-stage regenerative medicine biotech, is advancing PP405, its lead candidate for the treatment of androgenetic alopecia, into phase 3 trials.

PP405 is a first-in-class, non-invasive, topical small molecule therapy designed to stimulate dormant hair follicle stem cells and promote new hair growth.

Daniel Gil, CEO of Pelage Pharmaceuticals said: “Despite the growing need for treatments for hair loss, which affects more than 80% of men and 40% of women throughout their lifetimes, innovation has been lacking.

“Our approach is based on the groundbreaking discovery that hair follicle stem cells have a unique metabolic switch. Supported by over ten years of bench research on the mechanism and associated biological pathways, we have designed a first-in-class investigational treatment that reactivates these hair follicle stem cells to regrow hair.”

The company reported positive interim results from a randomised, placebo-controlled phase 2a trial in July 2025. The results showed that PP405 met its primary safety endpoint and demonstrated a clinically meaningful improvement compared with current treatments for androgenetic alopecia.

After completion of this phase 2a trial, patients in the placebo group were offered enrolment in a three-month open-label extension to evaluate long-term safety. A full data set from the trial is expected to be shared by the company at a future medical meeting in 2026.

Based on the strong safety profile and initial efficacy observations, Pelage plans to initiate a phase 3 trial in 2026 to further assess the safety and efficacy of PP405 in androgenetic alopecia.