Veradermics’ Oral VDPHL01 Achieved Early, Consistent, and Robust Hair Growth in Positive Phase 3 ‘304’ Clinical Trial in Male Pattern Hair Loss
VDPHL01, a novel orally-administered extended-release minoxidil formulation, met all primary and secondary endpoints with high statistical significance in both active treatment arms evaluating once-daily (QD) and twice-daily (BID) administration of VDPHL01
VDPHL01 demonstrated increases in target area hair count (TAHC) of 28.6 hairs/cm² (once-daily dosing; p<0.0001) and 36.4 hairs/cm² (twice-daily dosing; p<0.0001) versus 6.6 hairs/cm² for placebo at Month 6, a similar mean increase in TAHC that was observed in Study '302'
Approximately 78.8% (QD) and 85.0% (BID) of participants reported visible improvement in patient-reported outcomes (PRO) versus 35.3% of placebo participants; 55.7% (QD; p<0.0001) and 68.7% (BID; p<0.0001) of participants reported 'improved' or 'much improved' outcomes at Month 6 versus 15.0% of placebo participants
Onset of hair growth was observed with statistically significant separation from placebo in non-vellus TAHC, PRO, and Investigator Global Assessment (IGA) at Month 2, the earliest time point evaluated
VDPHL01 demonstrated a favorable safety and tolerability profile in more than 1,000 participants across two registration-directed studies with no new safety signals emerging in Study '304'
These results combined with previously reported positive topline findings from Part A of the Phase 2/3 clinical trial (Study '302') represent the full placebo-controlled data set to support the potential for VDPHL01 to become the first FDA-approved non-hormonal oral treatment for the 50 million men with pattern hair loss in the U.S.
Conference call and webcast scheduled for 8:00 a.m. ET today
NEW HAVEN, Conn., October 19, 2026--Veradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss, today announced positive topline results from Part A of its randomized, double-blind, placebo-controlled registration-directed Phase 3 clinical trial (Study '304') evaluating VDPHL01, a proprietary, extended-release oral minoxidil formulation, in over 500 males with mild-to-moderate pattern hair loss. These positive registration-directed results, combined with previously reported positive topline findings from Part A of the company's Phase 2/3 clinical trial (Study '302'), position VDPHL01 to potentially become the first FDA-approved oral pill in nearly 30 years for pattern hair loss and a potential best-in-indication treatment option for the 50 million men with pattern hair loss in the U.S. To date, 6-month placebo-controlled data has been reported for more than 1,000 participants in registration-directed studies of VDPHL01 for the treatment of male pattern hair loss.