Clinical trialsCompany release

Veradermics reports 12-month Phase 2/3 data for extended-release oral minoxidil in male hair loss

🇺🇸 Veradermics, Inc (MANE) · Mon 09 Nov 2026

Topline Part B results for VDPHL01 show hair-count gains in over 500 men, with no treatment-related serious adverse events or cardiac events of special interest.

Veradermics announced on 9 November 2026 topline 12-month results from Part B of Study '302', a Phase 2/3 trial of VDPHL01, its investigational extended-release oral minoxidil, in men with mild-to-moderate pattern hair loss. The study enrolled more than 500 participants.

Non-vellus hair count rose by 43.9 hairs/cm2 from baseline in the twice-daily group and by 29.7 hairs/cm2 in the once-daily group, according to the company.

On safety, Veradermics reports no treatment-related serious adverse events, no cardiac events of special interest and no new safety signals. The summary available does not give detail on the comparator arms, the definition of cardiac events of special interest or full adverse-event rates.

The company says the data support a potential pathway to approval by the US Food and Drug Administration. It expects data from Study '306', which is investigating female pattern hair loss, in the first half of 2027.

What it means for your team

  • Regulatory teams should note the company frames the data as supporting a possible FDA approval pathway; no filing timeline was given in the material reviewed.
  • Pharmacovigilance specialists will want the full safety dataset, particularly the cardiac events of special interest, as oral minoxidil's cardiovascular profile is a focus for this class.
  • Market-access teams should watch for the female pattern hair loss data from Study '306' expected in the first half of 2027, which would define the potential patient population.

Company's press release (SEC filing): Veradermics, Inc ↗

Article written by VigiEye from the official source (Veradermics, Inc). Claims are the company's own. AI-assisted; check the source before acting.

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