Veradermics, a dermatologist-founded, late-stage biopharmaceutical company, has announced that it has completed enrollment in its second Phase 3 trial evaluating VDPHL01 for male pattern hair loss. This paves the way for first oral NDA in nearly 30 years.

 

Combined with its previously announced Phase 2/3 enrollment, the milestone means more than 1,000 men are now enrolled across both Phase 3 programs.

 

VDPHL01 is an oral, extended-release formulation of minoxidil engineered to maximize hair restoration while reducing cardiac side effects. Its proprietary gel matrix delivers steady, long-lasting doses directly to hair follicles, aiming for rapid, consistent, and robust growth without exceeding plasma levels associated with cardiac risk.

 

“Completing enrollment across both Phase 3 trials in men marks a significant milestone for Veradermics and an important moment in the development of VDPHL01,” said Reid Waldman, Chief Executive Officer of Veradermics. 

 

“This achievement reflects the commitment of the investigators, study participants, and clinical teams who made it possible to execute a rigorous, registration-directed program in a condition that has seen limited therapeutic innovation for decades. With enrollment in our male trials now complete, we are advancing towards the first NDA filing for an oral treatment for pattern hair loss in nearly 30 years.”

 

The ‘304’ Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled study of 536 men with mild-to-moderate hair loss, testing two doses of VDPHL01 (8.5 mg once- and twice-daily) over 52 weeks. Co-primary endpoints include changes in non-vellus hair count and patient-reported hair coverage at 24 weeks.

 

Veradermics’ first Phase 2/3 male trial concluded in 2025, with topline data expected in the first half of 2026. Early results from a separate Phase 2 study showed visible and measurable hair growth with VDPHL01. The company is also actively recruiting women for its Phase 2/3 trial in female pattern hair loss.