Veradermics Phase 3 Study '304' meets all endpoints for VDPHL01 in male hair loss
Veradermics said its Phase 3 Study '304' of VDPHL01, an oral extended-release minoxidil tablet, met all primary and secondary endpoints with high statistical significance in 536 men with mild-to-moderate pattern hair loss. The company reported no treatment-related serious adverse events and no cardiac adverse events of special interest, and it said the results add to positive data from Study '302' for a potential first FDA-approved oral non-hormonal treatment for men, though approval has not been sought or granted.
Key points
- At Month 6, hair count rose 28.6 hairs/cm² (once daily) and 36.4 hairs/cm² (twice daily) versus 6.6 hairs/cm² for placebo, each with p<0.0001.
- 55.7% (once daily) and 68.7% (twice daily) of patients reported 'improved' or 'much improved' hair coverage versus 15.0% on placebo.
- Hypertrichosis was the only adverse event above 5% with a difference from placebo: 2.2% (once daily) and 9.0% (twice daily) versus 0% on placebo.
- Veradermics plans to report Part B of Study '302' later in 2026.
The filing
Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 19, 2026.
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