Veradermics (NYSE:MANE) announced positive topline results on Monday from Part A of its Phase 2/3 clinical trial evaluating VDPHL01, a proprietary extended-release oral minoxidil formulation.
The study, which enrolled 519 men with mild-to-moderate pattern hair loss, met all primary and key secondary endpoints with high statistical significance (p<0.0001).
The data suggests VDPHL01 could become the first FDA-approved oral treatment for androgenetic alopecia in nearly 30 years.
In the randomized, double-blind trial, patients receiving the treatment showed a marked increase in hair density compared to the placebo group.
Specifically, those on once-daily and twice-daily doses achieved average increases in non-vellus hair count of 30.3 hairs/cm² and 33.0 hairs/cm², respectively, compared to just 7.3 hairs/cm² for those on placebo.
Patient-reported outcomes were equally robust, with 86% of patients in the twice-daily arm reporting improved hair coverage.
Beyond efficacy, the clinical profile was distinguished by its safety results; VDPHL01 was generally well tolerated with no treatment-related serious adverse events and, notably, no cardiac-related adverse events of special interest—a common concern with traditional oral minoxidil use.