Oral Minoxidil Formulation VDPHL01 Meets Phase 3 Endpoints in Male Pattern Hair Loss
Key Takeaways
Veradermics reported positive topline results from its Phase 3 Study 304 evaluating VDPHL01, an investigational extended-release oral minoxidil formulation, in 536 men with mild-to-moderate androgenetic alopecia.
At 6 months, mean non-vellus hair counts increased by 28.6 hairs/cm² with once-daily dosing and 36.4 hairs/cm² with twice-daily dosing, compared with 6.6 hairs/cm² for placebo (P < 0.0001 for both comparisons).
Both regimens met the trial's coprimary endpoints, with no treatment-related serious adverse events or cardiac adverse events of special interest reported through 6 months.
Veradermics announced positive topline results from a Phase 3 trial evaluating VDPHL01, its investigational extended-release oral minoxidil formulation, in men with androgenetic alopecia. The treatment met all primary and secondary endpoints, with statistically significant improvements in hair counts and patient-reported outcomes compared with placebo.
The randomized, double-blind, placebo-controlled Study 304 enrolled 536 men with mild-to-moderate pattern hair loss. Participants received VDPHL01 8.5 mg once daily, 8.5 mg twice daily, or placebo.
Hair Growth and Patient-Reported Outcomes
At month 6, mean non-vellus target area hair counts 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 with placebo (P < 0.0001 for both comparisons).
On the Androgenetic Alopecia Impact Rating Scale, 55.7% and 68.7% of participants receiving once- and twice-daily VDPHL01, respectively, rated their hair coverage as improved or much improved, compared with 15.0% receiving placebo (P < 0.0001 for both comparisons).
Statistically significant differences from placebo emerged by month 2, the earliest assessment point, across hair counts, patient-reported outcomes, and investigator assessments.
Treatment was generally well tolerated through 6 months. Peripheral edema occurred in 2.8% and 4.5% of the once- and twice-daily groups, respectively, while hypertrichosis occurred in 2.2% and 9.0%. No treatment-related serious adverse events or cardiac adverse events of special interest were reported.
Results were consistent with previously announced findings from Study 302. However, both studies' reported efficacy findings remain topline company disclosures, and longer-term safety data are pending.
Source
Veradermics, Inc. News release. October 19, 2026.