Veradermics has completed enrolment in its second pivotal Phase III clinical trial of VDPHL01 for male pattern hair loss treatment.
The ‘304’ Phase III randomised, multi-centre, placebo-controlled, double-blind trial is assessing the efficacy and safety of VDPHL01 in 536 males with mild-to-moderate pattern hair loss.
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Participants will receive either 8.5mg once daily or twice daily for 52 weeks. The co-primary endpoints include non-vellus hair count changes and hair coverage benefit reported by patients at 24 weeks.
With this, the company now completed enrolment across both Phase III VDPHL01 trials evaluating candidates with male pattern hair loss, involving more than 1,000 participants.
VDPHL01 is an oral, extended-release minoxidil formulation, developed to optimise hair restoration benefits while aiming to minimise cardiac side effects.
The extended-release formulation of VDPHL01 uses a gel matrix for delivering steady and prolonged minoxidil exposure to hair follicles. This release profile is designed to support rapid and consistent hair growth without causing plasma concentration spikes that might trigger cardiac events.
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By GlobalDataVeradermics’ initial Phase II/III male trial concluded enrolment of participants in 2025, with top line results expected in the first half of 2026.
Preliminary data from a separate Phase II male trial announced last year indicated visible and measurable hair growth after VDPHL01 administration. The company is currently enrolling participants for its Phase II/III trial in females with pattern hair loss.
Veradermics CEO Reid Waldman said: “Completing enrolment across both Phase III trials in men marks a significant milestone for Veradermics and an important moment in the development of VDPHL01.
“This achievement reflects the commitment of the investigators, study participants, and clinical teams who made it possible to execute a rigorous, registration-directed programme in a condition that has seen limited therapeutic innovation for decades. With enrolment 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.”
