Veradermics said its experimental oral hair loss treatment VDPHL01 met all primary and secondary endpoints in a Phase 3 trial, increasing hair counts and patient-reported hair coverage compared with placebo after six months.
The randomized, double-blind Study 304 enrolled 536 men with mild-to-moderate pattern hair loss. Participants received 8.5 milligrams of VDPHL01, an extended-release minoxidil formulation, once daily, twice daily or placebo.
Average increases in target-area hair counts were 28.6 hairs per square centimeter with once-daily treatment and 36.4 with twice-daily treatment, compared with 6.6 for placebo. Both treatment comparisons were statistically significant, with p-values below 0.0001.
The other co-primary endpoint measured participants reporting “improved” or “much improved” hair coverage. That threshold was reached by 55.7% in the once-daily group and 68.7% in the twice-daily group, versus 15% receiving placebo.
Statistically significant differences from placebo appeared by month two, the earliest assessment, across hair counts, patient reports and investigator assessments.
Veradermics reported no treatment-related serious adverse events or cardiac adverse events of special interest through six months.
Peripheral edema occurred in 2.8% and 4.5% of the once- and twice-daily groups, respectively, versus 0.6% with placebo. Excess hair growth occurred in 2.2% and 9%, versus none with placebo.
The findings follow positive six-month results from Study 302, a separate Phase 2/3 trial in men.
Veradermics expects longer-term Study 302 data later this year, extending safety observations to 12 months. Results from a Phase 2/3 trial in women are expected in the first half of 2027. VDPHL01 remains under development for potential regulatory approval.
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