Veradermics reports positive Phase 3 topline data for oral minoxidil in male hair loss

Veradermics, Incorporated (NYSE: MANE) announced on October 19, 2026 that its randomized, double-blind, placebo-controlled registration-directed Phase 3 trial, Study '304', produced positive topline results from Part A, testing VDPHL01, an extended-release oral minoxidil formulation, in more than 500 men with mild-to-moderate pattern hair loss.¹ The trial randomized 536 participants to VDPHL01 8.5mg once daily, VDPHL01 8.5mg twice daily, or placebo.¹

The trial met all primary and secondary endpoints with high statistical significance, showing rapid onset, consistent response across participants, and robust increases in hair count, with no treatment-related serious adverse events and no cardiac adverse events of special interest.¹ On the co-primary endpoints, participants gained an average of 28.6 hairs/cm² (once-daily) and 36.4 hairs/cm² (twice-daily) in non-vellus hair count versus a 6.6 hairs/cm² increase for placebo at Month 6.¹ For patient-reported outcomes, 55.7% of once-daily and 68.7% of twice-daily participants reported "improved" or "much improved" hair coverage versus 15.0% of placebo participants.¹

Statistically significant separation from placebo on hair count, patient-reported outcome, and investigator assessment appeared as early as Month 2, the earliest time point measured.¹ Safety through Month 6 was generally consistent with the earlier Study '302', with no treatment-related serious adverse events and no cardiac adverse events of special interest.¹

The company said it expects to report data from Part B of Study '302' later in 2026, and it completed enrollment in August for its female pattern hair loss trial, Study '306', with topline results anticipated in the first half of 2027.¹