Veradermics Reports Positive Topline Results from Phase 3 Study 304 for Oral Minoxidil VDPHL01

Veradermics, Incorporated announced on October 19, 2026, that its Phase 3 clinical trial, Study '304', met all primary and secondary endpoints with high statistical significance. The study evaluated VDPHL01, a proprietary extended-release oral minoxidil formulation, in males with mild-to-moderate pattern hair loss. The trial enrolled 536 participants who were randomized to receive either VDPHL01 8.5mg once daily, VDPHL01 8.5mg twice daily, or placebo.

According to the filing, VDPHL01 demonstrated superior hair growth compared to placebo on co-primary endpoints at Month 6. Patients in the once-daily arm achieved an average increase in non-vellus target area hair count (TAHC) of 28.6 hairs/cm², while the twice-daily arm achieved 36.4 hairs/cm². Placebo patients saw an increase of 6.6 hairs/cm². The trial also reported that 78.8% of patients in the once-daily arm and 85.0% in the twice-daily arm reported improvement in hair coverage on the Androgenetic Alopecia Impact Rating Scale (AAIRS), compared to 35.3% of placebo patients.

Investigators graded 78.4% of patients in the once-daily arm and 82.7% in the twice-daily arm as having improved hair coverage at Month 6, compared to a placebo group. The filing notes that statistically significant separation from placebo was observed on TAHC, patient-reported outcomes, and Investigator Global Assessment (IGA) as early as Month 2.

Regarding safety, the company stated that VDPHL01 was generally well tolerated through Month 6. No treatment-related serious adverse events (SAEs) or adverse events of special interest (AESIs) of cardiac origin were observed. The only treatment-emergent adverse events occurring in greater than 5% of patients with an imbalance between active and placebo arms were hypertrichosis, occurring in 2.2% of the once-daily arm and 9.0% of the twice-daily arm.

Veradermics stated that these results, combined with previously reported data from 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 pattern hair loss in the U.S. The company also noted that enrollment for its female pattern hair loss Phase 2/3 trial, Study '306', was completed in August 2026, with data anticipated in the first half of 2027.