Investigational Oral Hair Loss Pill Outperformed Minoxidil, Finasteride in Phase 2/3 Study, With Michael Gold, MD

Male pattern hair loss affects an estimated 50 million men in the US, yet the last FDA approval for a treatment targeting the condition came nearly 30 years ago. Since then, clinicians have relied on topical minoxidil and oral finasteride, along with off-label use of immediate-release oral minoxidil, a formulation originally developed to treat hypertension and not optimized for sustained follicular drug delivery.

Veradermics' investigational VDPHL01, an extended-release oral minoxidil tablet, is now the first oral minoxidil formulation to generate positive Phase 3 efficacy and safety data in male pattern hair loss. In Study '302', a randomized, double-blind, placebo-controlled Phase 2/3 trial enrolling 519 men with mild-to-moderate pattern hair loss, once-daily VDPHL01 produced a mean increase of 30.3 hairs/cm² in non-vellus target area hair count at 6 months versus 7.3 hairs/cm² with placebo (p < .0001). Statistically significant separation from placebo was observed as early as Month 2. The trial also met its patient-reported outcome coprimary endpoint, with 79.3% of once-daily patients reporting improved hair coverage on the Androgenetic Alopecia Impact Rating Scale versus 35.6% of placebo patients.

"VDPHL01 is the first oral minoxidil formulation developed specifically for pattern hair loss, and now the first to generate positive Phase 3 results of efficacy and safety," Michael H. Gold, MD, trial investigator and board-certified dermatologist, said in an interview with Patient Care Online. In the clip above, Gold discusses how these results compare with currently available treatments and what the extended-release pharmacology means for clinical practice.

References:

1. Veradermics. Veradermics’ Oral VDPHL01 Achieved Early, Consistent, and Robust Hair Growth in Positive Phase 2/3 ‘302’ Clinical Trial in Male Pattern Hair Loss. News release. April 27, 2026. Accessed April 29, 2026. https://ir.veradermics.com/news-releases/news-release-details/veradermics-oral-vdphl01-achieved-early-consistent-and-robust