Veradermics reports positive Phase 2/3 data for VDPHL01, an oral minoxidil, showing significant hair growth and favorable safety in men with pattern hair loss.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Veradermics reported positive topline results from Part A of its randomized, double-blind, placebo-controlled Phase 2/3 Study ‘302’ (NCT06724614) evaluating VDPHL01, an extended-release oral minoxidil, in 519 males with mild-to-moderate pattern hair loss.
Participants were randomized to receive VDPHL01 8.5 mg once daily (QD), twice daily (BID), or placebo. The study met all primary and key secondary endpoints with statistical significance (p<0.0001).
At Month 6, VDPHL01 demonstrated superior increases in non-vellus Target Area Hair Count (TAHC), with gains of 30.3 hairs/cm² (QD) and 33.0 hairs/cm² (BID), compared with 7.3 hairs/cm² for placebo. Patient-reported outcomes on the Androgenetic Alopecia Impact Rating Scale (AAIRS) improved in 79.3% (QD) and 86.0% (BID) of patients versus 35.6% with placebo.
Investigator assessments showed improved hair coverage in 72.0% (QD) and 84.4% (BID) of patients. Separation from placebo on TAHC and Investigator’s Global Assessment was observed as early as Month 2.
VDPHL01 was generally well tolerated, with treatment-emergent adverse event rates comparable to placebo, lower discontinuation rates, no treatment-related serious adverse events, and no cardiac adverse events of special interest reported.
Experts like Dr. Maryanne Makredes Senna, board-certified dermatologist and Dr. Michael Gold, Study ‘302’ trial investigator highlighted its potential to transform male pattern hair loss treatment as the first oral minoxidil formulated specifically for this indication.
CEO Reid Waldman emphasized the formulation’s design for consistent exposure and minimized cardiac risks, positioning VDPHL01 if approved as the first FDA-approved oral pill for pattern hair loss in nearly 30 years, protected by patents to 2043.
Study ‘302’ supports a broader development program, including completed enrollment in the Phase 3 Study ‘304’ in males, with topline data expected in the second half of 2026, and an ongoing Phase 3 Study ‘306’ in females.
Pattern hair loss affects an estimated 80 million people in the U.S. and is associated with a growing aesthetics market projected to reach $30 billion by 2028.
Reference
Study Details | NCT06724614 | Efficacy and Safety of VDPHL01 in Males With AGA | ClinicalTrials.gov