NEW HAVEN, Conn. — Veradermics Inc. said its experimental oral treatment for pattern hair loss delivered significant and consistent hair growth in a late-stage clinical trial, positioning the drug as a potential new option for millions of patients.
The company reported positive topline results from Part A of its Phase 2/3 study evaluating VDPHL01, an extended-release oral minoxidil formulation, in more than 500 men with mild-to-moderate pattern hair loss.
The randomized, placebo-controlled trial met all primary and key secondary endpoints, with patients receiving the treatment showing substantially greater hair growth compared with placebo.
After six months, patients taking VDPHL01 once daily saw an average increase of 30.3 hairs per square centimeter, while those on twice-daily dosing achieved an increase of 33.0 hairs per square centimeter. By comparison, the placebo group saw a 7.3 hairs per square centimeter increase.
Patient-reported outcomes also improved significantly, with 79.3% of patients in the once-daily group and 86.0% in the twice-daily group reporting some level of improvement, compared with 35.6% of those receiving placebo.
The study enrolled 519 participants, who were randomized to receive either once-daily or twice-daily dosing of VDPHL01 or placebo. Researchers reported statistically significant improvements as early as two months into treatment.
“Based on the results of the ‘302’ trial, VDPHL01, if approved, has the potential to transform how physicians and patients approach pattern hair loss for men,” said Maryanne Makredes Senna, M.D., a dermatologist and member of the company’s scientific advisory board. “I believe that an oral therapy that has improved hair loss in the eyes of nearly 80% of patients and investigators, was generally well tolerated in trials and sits in a class that dermatologists are already comfortable prescribing, has the potential to transform the treatment landscape for male pattern hair loss.”
Investigators also reported improvements in hair coverage, with up to 84.4% of patients in the twice-daily group showing visible gains at six months.
The treatment was generally well tolerated, with adverse event rates similar to placebo and no treatment-related serious adverse events reported.
“VDPHL01 is the first oral minoxidil formulation developed specifically for pattern hair loss, and now the first to generate positive Phase 3 results of efficacy and safety,” said Michael Gold, M.D., a trial investigator.
Chief Executive Officer Reid Waldman said the results support the company’s approach to improving the safety and consistency of oral minoxidil therapy.
“With a formulation designed to deliver more consistent exposure and avoid peak concentrations associated with dose-limiting cardiac side effects, we believe VDPHL01 has a potentially differentiated, generally well tolerated clinical profile with rapid, consistent, and robust hair growth,” Waldman said.
Veradermics said the drug could become the first FDA-approved non-hormonal oral treatment for pattern hair loss, a condition affecting tens of millions of people in the United States.
The company is continuing its development program, with additional late-stage trial results expected later this year and ongoing studies evaluating the treatment in women.
