Veradermics, a biopharmaceutical company specializing in dermatology, has finished enrolling participants in its second Phase 3 clinical trial for its new oral minoxidil, VDPHL01, aimed at treating male pattern hair loss. With over 1,000 men enrolled across the two Phase 3 studies, the company is moving closer to submitting the first oral drug application for hair restoration in nearly three decades.
VDPHL01 is a unique, extended-release version of minoxidil designed to improve hair growth while minimizing heart-related side effects. The drug uses a special gel matrix to deliver steady doses of minoxidil directly to hair follicles, which is intended to provide strong and consistent hair growth without raising the minoxidil levels that could affect the heart.
The latest trial, known as the ‘304’ Phase 3 study, recruited 536 men with mild to moderate hair loss. The study is taking place at multiple centers, and uses a randomized, double-blind, placebo-controlled design. Researchers are testing two doses of VDPHL01 (8.5 mg once or twice daily) over a period of 52 weeks. The main goals are to measure changes in the number of non-vellus hairs and to gather patient feedback on their hair coverage after 24 weeks.
According to Veradermics’ CEO, Reid Waldman, completing participant enrollment is a major step forward for the company and signals progress in developing new treatments for a condition that has seen little innovation for many years. The earlier Phase 2/3 trial wrapped up in 2025, with results expected in the first half of 2026. Preliminary findings from a separate Phase 2 trial have already shown visible and measurable hair growth with the oral minoxidil.
Besides the trials focused on men, Veradermics is also recruiting women for a Phase 2/3 trial aimed at female pattern hair loss. The company plans to advance toward regulatory approval once the ongoing trials are complete and results are available.
