Phase 3 Trial of Oral Minoxidil Formulation Meets Primary Endpoints in Male Pattern Hair Loss
Key Takeaways
- Phase 3 Study 304 met both co-primary endpoints in 536 men with mild-to-moderate pattern hair loss.
- At 6 months, mean nonvellus hair count rose 28.6 hairs/cm² with once-daily and 36.4 hairs/cm² with twice-daily VDPHL01, versus 6.6 hairs/cm² with placebo.
- No treatment-related serious adverse events or cardiac adverse events of special interest were reported through 6 months; peripheral edema and hypertrichosis occurred.
Veradermics announced positive topline results from its Phase 3 Study 304 evaluating VDPHL01, an investigational extended-release oral minoxidil formulation, in men with mild-to-moderate androgenetic alopecia. The randomized, double-blind, placebo-controlled trial met both co-primary endpoints at 6 months, according to company-reported findings.¹
The study enrolled 536 men randomized to receive VDPHL01 8.5 mg once daily, 8.5 mg twice daily, or placebo. Co-primary endpoints included change from baseline in nonvellus target area hair count and the proportion of participants reporting improved or much improved hair coverage on the Androgenetic Alopecia Impact Rating Scale (AAIRS).
Hair Count and Patient-Reported Outcomes
At month 6, mean nonvellus hair count increased by 28.6 hairs/cm² in the once-daily group and 36.4 hairs/cm² in the twice-daily group, compared with 6.6 hairs/cm² in the placebo group (P < .0001 for both active-treatment comparisons).
Patient-reported improvement was also greater with active treatment. On the AAIRS, 55.7% of once-daily recipients and 68.7% of twice-daily recipients reported improved or much improved hair coverage, compared with 15.0% of placebo recipients (P < .0001 for both comparisons).
Investigators reported statistically significant separation from placebo in hair count and clinical assessments as early as month 2.
VDPHL01 was generally well tolerated through 6 months, with no treatment-related serious adverse events or cardiac adverse events of special interest reported. Peripheral edema occurred in 2.8% and 4.5% of the once- and twice-daily groups, respectively, compared with 0.6% of placebo recipients. Hypertrichosis occurred in 2.2%, 9.0%, and 0%, respectively.
The findings were consistent with previously reported results from Study 302, another registration-directed trial.
Veradermics anticipates reporting 12-month data from Study 302 later in 2026. VDPHL01 remains investigational and is not FDA-approved for pattern hair loss.
- Veradermics, Inc. Veradermics announces positive topline results from Phase 3 Study 304 of VDPHL01 in male pattern hair loss. Company press release. October 19, 2026. Supplied source material.