Veradermics’ Oral VDPHL01 Achieved Early, Consistent, and Robust Hair Growth in Positive Phase 3 ‘304’ Clinical Trial in Male Pattern Hair Loss
Veradermics' Phase 3 Study '304' met all primary and secondary endpoints for VDPHL01, an oral extended-release minoxidil for male pattern hair loss, in 536 participants with high statistical significance (p<0.0001). Hair count gains reached 28.6 hairs/cm² (once daily) and 36.4 hairs/cm² (twice daily) versus 6.6 for placebo at Month 6, with onset of efficacy visible as early as Month 2 and no treatment-related serious adverse events or cardiac adverse events of special interest. Combined with positive Study '302' data, the results support a potential NDA as the first FDA-approved non-hormonal oral treatment targeting 50 million U.S.
Key figures
- Drug Name
- VDPHL01 (extended-release oral minoxidil)
- Phase Of Trial
- Phase 3
- Tahc qd
- 28.6 hairs/cm² (p<0.0001)
- Tahc bid
- 36.4 hairs/cm² (p<0.0001)
- Pro placebo
- 15.0%
- Tahc placebo
- 6.6 hairs/cm²
- Study 304 enrollment
- 536
- Registration program enrollment
- more than 1,600
- Pro improved or much improved qd
- 55.7%
- Pro improved or much improved bid
- 68.7%
AI analysis
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