Veradermics reported positive phase 3 results for its oral minoxidil product targeting mild-to-moderate pattern hair loss. The findings come from Study ‘304’, positioning the drug as a potential first FDA-approved oral pill for the condition in almost 30 years.
Study ‘304’ enrolled 536 men who were randomly assigned to receive either 8.5 mg of the extended-release formulation once daily, the same dose twice daily, or a placebo.
The trial met all primary and secondary endpoints with high statistical significance, showing rapid activity, consistent responses across participants, and notable increases in hair count. No treatment-related serious adverse events or cardiac-related adverse events of special interest were reported.
Chief executive Reid Waldman said, “With topline findings from our phase 3 Study ‘304’, we have now reported positive topline placebo-controlled data from two registration-directed trials that together enrolled more than 1,000 male participants.”
He added, “These results indicated that our proprietary, extended-release VDPHL01 formulation delivered marked increases in hair growth, while minimising side effects and cardiac risk.”
The firm previously reported positive topline findings from Study ‘302’, a phase 2/3 trial that also met its endpoints. Later this year, it expects to release longer-term data from Part B of that study, extending safety observations to 12 months.
Because an oral non-hormonal option has not been approved in the United States for about three decades, the emergence of VDPHL01 could address a persistent treatment gap for the estimated 50 million American men with pattern hair loss. Its extended-release design may also mitigate the cardiovascular concerns that have constrained earlier oral formulations, offering a safer alternative for patients.
The formulation employs a gel matrix that releases minoxidil steadily, avoiding the high-peak concentrations typical of immediate-release tablets. This sustained absorption aims to keep drug levels above the minimum threshold needed for hair growth over a longer period. The matrix technology also smooths the release curve, reducing the chance of sudden spikes that could raise cardiac risk.
If approved, the drug would become the sole FDA-approved oral, non-hormonal treatment for pattern hair loss in both men and women, expanding therapeutic options beyond topical applications. Such approval would mark a notable shift in how clinicians manage this common condition.
To date, six-month placebo-controlled results have been reported for the same cohort across registration-directed studies of the formulation in male pattern hair loss.
