Veradermics' VDPHL01 Meets All Primary And Secondary Endpoints In Phase 3 Study, Demonstrates Significant Hair Count Gains And Favorable Safety Profile

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.

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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.

Study ‘304’ enrolled 536 participants who were randomized to receive either VDPHL01 8.5mg once daily (QD), VDPHL01 8.5mg twice daily (BID), or placebo. The trial met all primary and secondary endpoints with high statistical significance, demonstrating a potentially differentiated clinical profile defined by rapid onset of activity, consistent response across participants, and robust increases in hair count while being generally well tolerated with no treatment-related serious adverse events (SAEs) and no adverse events of special interest (AESIs) of cardiac origin.

Topline Study ‘304’ Double-Blind, Placebo-Controlled Results

In Part A of Study ‘304’, VDPHL01 achieved superior hair growth compared with placebo (p<0.0001) on the co‑primary endpoints of non-vellus Target Area Hair Count (TAHC) and patient-reported outcome (PRO) benefit of ‘improved’ or ‘much improved’ on the Androgenetic Alopecia Impact Rating Scale (AAIRS) at Month 6. Participants achieved an average increase in non-vellus hair count of 28.6hairs/cm² (p<0.0001) and 36.4 hairs/cm² (p<0.0001) in once-daily and twice-daily VDPHL01 treatment arms, respectively. Those receiving placebo showed a 6.6 hairs/cm² increase from baseline at Month 6.

Following 6 months of treatment with VDPHL01, 78.8% of participants in the once-daily dose arm (p<0.0001) and 85.0% of participants in the twice-daily dose arm (p<0.0001) reported improvement in hair coverage on the AAIRS versus 35.3% of placebo participants. Additionally, 55.7% of participants in the once-daily dose arm (p<0.0001) and 68.7% of participants in the twice-daily dose arm (p<0.0001) achieved ‘improved’ or ‘much improved’ hair coverage on the AAIRS compared to 15.0% of placebo participants.

The consistency of clinically meaningful hair growth reported by participants was further supported by investigator perception of hair growth, with investigators grading 78.4% (QD; p<0.0001) and 82.7% (BID; p<0.0001) of male participants as having improved hair coverage at Month 6 (p<0.0001) using the Investigator Global Assessment (IGA) scale. Rapid onset of hair growth was also observed at the earliest time point measured in the trial, with statistically significant separation from placebo on TAHC, PRO, and IGA as early as Month 2.

Treatment with VDPHL01 was generally well tolerated through Month 6 with an overall safety profile consistent with Study ‘302’. No treatment-related SAEs and no AESIs of cardiac origin were observed in the study.

Study ‘304’ is part of Veradermics’ registration-directed development program to support the potential approval of VDPHL01 in both male and female pattern hair loss. In April 2026, Veradermics announced positive topline results from Part A of its randomized, double-blind, placebo-controlled Phase 2/3 clinical trial (Study ‘302’) evaluating VDPHL01 in over 500 males with mild-to-moderate pattern hair loss. The Company anticipates announcing data from Part B of Study ‘302’ later this year. Veradermics also announced in August completion of participant enrollment for its female pattern hair loss Phase 2/3 trial, Study ‘306’, with a readout of topline data anticipated in the first half of 2027.