Veradermics' Extended-Release Minoxidil Pill Shows Promise in Phase 3 Trial
An experimental oral, extended-release version of minoxidil, known as VDPHL01, has shown significant hair regrowth in men with pattern hair loss in a phase 3 trial. Developed by Connecticut-based Veradermics, the drug aims to be the first new pill for pattern baldness in nearly 30 years. While it offers potential benefits over immediate-release versions, it carries higher minoxidil doses and requires further regulatory approval.
Key points
- VDPHL01 is an oral, extended-release formulation of minoxidil, the active ingredient in Rogaine, designed to treat pattern hair loss.
- A phase 3 trial involving 536 men with mild to moderate hair loss found that both once-daily and twice-daily doses outperformed a placebo.
- Participants taking the once-daily dose gained an average of 28.6 hairs per square centimeter, while those taking it twice daily gained 36.4 hairs, compared to 6.6 for the placebo group.
- The extended-release formulation may reduce side effects like dizziness and blood pressure changes by lowering peak concentration, though it contains nearly twice the maximum recommended daily dose of minoxidil.
- Veradermics hopes to gain FDA approval within two to three years, potentially making it the first non-hormonal oral treatment for pattern hair loss.
Background
Hair loss affects approximately 50 million men and 30 million women globally. While no cure exists for genetic or age-related hair loss, treatments like minoxidil have been used to slow decline and promote regrowth. Previous oral minoxidil treatments were immediate-release, leading to more side effects. Veradermics' new extended-release version aims to improve tolerability and efficacy.
Why it matters
The potential approval of VDPHL01 could provide a new, convenient treatment option for millions of people suffering from pattern hair loss. As the first new pill for this condition in nearly 30 years, it may offer improved efficacy and reduced side effects compared to existing treatments, potentially changing the landscape of hair loss management.
What to watch
Veradermics is recruiting women for a phase 3 trial for female pattern hair loss. If the current studies continue to show positive results, the company plans to submit for FDA approval, with hopes of market availability within two to three years.
- Men battling baldness may soon have a new pill to turn to New York Post
- Veradermics' oral hair-loss drug shown to boost hair growth in late-stage study Reuters
- Veradermics’ stock up on male hair loss trial success Clinical Trials Arena
- Why This Hair Restoration Biotech's Shares Are Soaring The Motley Fool
- The week in pharma: action, reaction and insight – week to October 23, 2026 The Pharmaletter
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