Veradermics Reports Positive Phase 3 Results for Oral Hair Loss Drug VDPHL01
Veradermics, Incorporated (NYSE:MANE) reported positive late-stage clinical trial results for VDPHL01, its experimental extended-release oral treatment for male pattern hair loss. In the Phase 3 Study 304 involving 536 male participants, the medication met all primary and secondary endpoints. Participants receiving once-daily or twice-daily doses achieved hair count increases of 28.6 and 36.4 hairs per square centimeter at six months, compared to 6.6 in the placebo group.
The trial results position VDPHL01 to potentially become the first new oral pill approved by the U.S. Food and Drug Administration for pattern hair loss in nearly 30 years. The medication was generally well tolerated, with no treatment-related serious adverse events and no cardiac-related adverse events of special interest observed through six months of treatment.
Looking ahead, Veradermics expects to announce 12-month longer-term safety data from another late-stage study later this year. The company is also conducting a clinical trial evaluating VDPHL01 in female pattern hair loss, with topline results anticipated in the first half of 2027.
Key points
- Veradermics Phase 3 trial of oral drug VDPHL01 met all primary and secondary endpoints in male pattern hair loss.
- Participants taking VDPHL01 gained up to 36.4 hairs/cm² at 6 months versus 6.6 hairs/cm² for placebo.
- The trial reported no treatment-related serious adverse events and no cardiac safety concerns.
- Veradermics expects 12-month safety data later this year and female trial results in the first half of 2027.
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What were the results of the Veradermics VDPHL01 Phase 3 trial?
VDPHL01 met all primary and secondary endpoints in Study 304, showing significant hair growth in men after 6 months with no serious treatment-related adverse events or cardiac issues.
Is VDPHL01 approved by the FDA?
VDPHL01 is an investigational drug in Phase 3 development. If approved, it could become the first new FDA-approved oral treatment for pattern hair loss in nearly 30 years.
When will Veradermics release more VDPHL01 trial data?
Veradermics expects to report 12-month safety data later this year and topline data from its female hair loss trial in the first half of 2027.