An extended-release oral minoxidil pill just cleared a major hurdle. In a phase 3 trial of 536 men with male pattern baldness, VDPHL01 significantly outperformed placebo on hair regrowth at 6 months — with improvements seen as early as month 2. If approved, it could be the first FDA-approved oral pill for pattern hair loss in nearly three decades.
An extended-release oral minoxidil pill just cleared a major hurdle.
Veradermics announced positive phase 3 results for VDPHL01, an oral extended-release formulation of minoxidil, in men with androgenetic alopecia (male pattern baldness). In a 536-person trial, both once-daily and twice-daily doses significantly outperformed placebo on hair regrowth at 6 months — with some improvements visible as early as month 2. The drug was generally well tolerated, with no treatment-related serious or cardiac adverse events reported.
Dermatologists have long used low-dose oral minoxidil off-label, but existing immediate-release versions can cause side effects like dizziness and blood pressure changes due to peak drug concentrations. The extended-release design of VDPHL01 may help smooth those peaks, potentially improving the side effect profile.
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Why it matters: Hair loss affects millions, and current FDA-approved options are limited. If VDPHL01 gains approval, it would be the first oral pill approved for pattern hair loss in nearly 30 years — giving dermatologists a new, evidence-backed tool to personalize treatment.
