Veradermics’ Oral VDPHL01 Achieved Early, Consistent, and Robust Hair Growth in Positive Phase 3 ‘304’ Clinical Trial in Male Pattern Hair Loss
Key Highlights
- ➤VDPHL01 8.5 mg once daily increased target-area hair count by 28.6 hairs/cm²
- ➤VDPHL01 twice daily increased target-area hair count by 32.1 hairs/cm²
- ➤Study ‘304’ met all primary and secondary endpoints with high statistical significance
- ➤Study ‘304’ enrolled 536 men; both active arms showed significant hair-growth improvements
- ➤Study ‘306’ female pattern hair-loss topline data expected in the first half of 2027
Expert Statements
Reid Waldman, M.D., Chief Executive Officer of Veradermics
“With topline findings from our Phase 3 Study ‘304’, we have now reported positive topline placebo-controlled data from two registration-directed trials that together enrolled more than 1,000 male participants. These results indicated that our proprietary, extended-release VDPHL01 formulation delivered marked increases in hair growth, while minimizing side effects and cardiac risk”
Reid Waldman, M.D., Chief Executive Officer of Veradermics
“Based on these results, we believe VDPHL01 has the potential to transform the treatment of pattern hair loss for millions of people. Later this year, we also anticipate reporting the longer-term data from Part B of Study ‘302’, further extending the safety findings of VDPHL01 in males through 12 months.”
Antonella Tosti, M.D., Fredric Brandt Endowed Professor of Dermatology and Cutaneous Surgery, University of Miami
“The Phase 3 data for VDPHL01 for males helps address two important questions patients ask about a hair loss treatment: ‘Am I likely to see a difference, and will I feel comfortable taking it?’ The results showed a high likelihood of visible improvement, with a safety and tolerability profile that is encouraging,”
Antonella Tosti, M.D., Fredric Brandt Endowed Professor of Dermatology and Cutaneous Surgery, University of Miami
“The consistency of the findings across Studies ‘302’ and ‘304’, the large number of participants studied, and the rigor of the hair growth assessments give me confidence in these results. I believe VDPHL01 has the potential to become the new standard of care for male pattern hair loss, if approved.”
Michael J. Payette, M.D., M.B.A., Central Connecticut Dermatology, Associate Clinical Professor, UConn Health
“We have had limited advances in prescription treatments for pattern hair loss, and achieving patients’ treatment goals remains a challenge. That can be frustrating for patients and for those of us treating them,”
Michael J. Payette, M.D., M.B.A., Central Connecticut Dermatology, Associate Clinical Professor, UConn Health
“The VDPHL01 results are encouraging and give us reason to expect more from treatment. If approved, VDPHL01 could give physicians greater confidence to bring up hair loss, offer treatment, and help more patients see a meaningful improvement in their pattern hair loss.”
Veradermics’ Oral VDPHL01 Achieved Early, Consistent, and Robust Hair Growth in Positive Phase 3 ‘304’ Clinical Trial in Male Pattern Hair Loss
VDPHL01, a novel orally-administered extended-release minoxidil formulation, met all primary and secondary endpoints with high statistical significance in both active treatment arms evaluating once-daily (QD) and twice-daily (BID) administration of VDPHL01
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