Veradermics announced Monday that its experimental oral hair loss pill, VDPHL01, met all primary and key secondary endpoints in a late-stage clinical trial. Veradermics stock (NYSE: MANE) was up 45% in morning trading.
The Phase 2/3 trial enrolled 519 men with mild-to-moderate pattern hair loss, randomized to receive VDPHL01 8.5mg once daily, VDPHL01 8.5mg twice daily, or placebo. After six months, patients in the once-daily arm gained an average of 30.3 hairs per square centimeter compared with 7.3 hairs per square centimeter in the placebo group. Patients in the twice-daily arm gained 33.0 hairs per square centimeter.
On patient-reported outcomes, 79.3% of once-daily patients and 86.0% of twice-daily patients reported improvement in hair coverage, compared with 35.6% of placebo patients. Investigators graded 72.0% of once-daily patients and 84.4% of twice-daily patients as having improved hair coverage at month six. Statistically significant separation from placebo was observed as early as month two, the earliest time point measured.
The trial reported no treatment-related serious adverse events and no adverse events of cardiac origin. Overall adverse event rates were similar between the treatment and placebo groups, Veradermics said.
“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,” Michael Gold, M.D., a study investigator and board-certified dermatologist, said in a statement.
The active ingredient in VDPHL01 is minoxidil, the compound best known commercially as Rogaine. Oral minoxidil has a long history of off-label use for hair loss, though the threat of cardiovascular side effects — heart palpitations and blood pressure drops among them — has kept physicians from pushing doses higher, according to MarketWatch. For hair loss specifically, prescribers have generally topped out at 5 milligrams. Through a gel-matrix delivery system, VDPHL01 is engineered to smooth out the absorption curve — blunting the concentration spikes that drive cardiovascular side effects while keeping minoxidil levels high enough, for long enough, to stimulate follicle activity.
Roughly 80 million Americans — an estimated 50 million men and 30 million women — live with pattern hair loss, and the prescription treatment landscape has seen little meaningful change over the past three decades. Current options include topical minoxidil, finasteride, and a range of over-the-counter supplements with limited clinical backing.
If approved, VDPHL01 would be the first FDA-approved non-hormonal oral treatment for pattern hair loss for both men and women, Veradermics said. Two additional studies are underway: a second Phase 3 trial in men, Study ‘304’, whose data are expected in the second half of 2026, and Study ‘306’, a Phase 2/3 trial currently enrolling women.