Veradermics Completes Enrollment In Second Phase 3 Registration-Directed Clinical Trial Evaluating VDPHL01 For Treatment Of Male Pattern Hair Loss
Veradermics, Incorporated MANE | 64.19 | +9.20% |
- This marks the completion of enrollment of all male Phase 3 studies of VDPHL01 in pattern hair loss, with approximately 1,000 male patients enrolled across studies
- Topline data from initial '302' trial anticipated in the first half of 2026; '304' confirmatory study topline data anticipated in the second half of 2026
- VDPHL01, if approved, has the potential to be the first and only non-hormonal oral FDA approved treatment for men and women with pattern hair loss, a condition affecting an estimated 50 million men and 30 million women in the United States
Veradermics, Incorporated (NYSE:MANE), a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for common aesthetic and dermatological conditions, today announced completion of enrollment in its second Phase 3 registration-directed clinical trial evaluating VDPHL01 for the treatment of male pattern hair loss. Following the previously announced completion of enrollment in Veradermics' first Phase 2/3 trial, this milestone marks the completion of enrollment across both Phase 3 clinical trials of VDPHL01 in males, encompassing more than 1,000 participants.
VDPHL01 is an oral, extended-release (ER), formulation of minoxidil designed to maximize minoxidil's impact on hair restoration while improving tolerability by minimizing the risk of cardiac side effects. VDPHL01's proprietary extended-release formulation utilizes a gel matrix to deliver long-lasting, steady release of minoxidil to hair follicles over time. This release profile is intended to enable fast, consistent and intense hair growth, without inciting concentration spikes above minoxidil's identified cardiac activity threshold, the plasma level at which cardiac effects are first observed.
