On Monday, Veradermics Incorporated (NYSE:MANE) announced positive topline results from Part B of its registration-directed Phase 2/3 Study 302 evaluating VDPHL01, its investigational oral minoxidil formulation.
Combined with prior positive results from Study 302 Part A and Phase 3 Study 304 Part A, the findings position the therapy to potentially become the first FDA-approved oral pill for pattern hair loss in nearly 30 years, addressing an addressable market of 50 million American men.
Study 302 enrolled 519 male patients with mild-to-moderate pattern hair loss, testing 8.5mg once-daily and twice-daily doses against a placebo for six months before crossing placebo participants into active treatment.
Consistent Hair Growth and Patient Satisfaction
Patients continuing on active therapy achieved substantial hair density gains from baseline to Month 12.
The twice-daily cohort demonstrated deepened hair growth with an increase of 43.9 non-vellus hairs per square centimeter, while the once-daily arm maintained growth with a 29.7-hair gain.
Participant feedback closely mirrored these physical measurements. On the Androgenetic Alopecia Impact Rating Scale, 89.1% of twice-daily and 79.8% of once-daily participants noted visible coverage improvements.
In addition, 68.0% of twice-daily recipients and 48.4% of once-daily recipients rated their hair coverage as improved or much improved.
Clinicians corroborated this progress, grading 92.2% of twice-daily and 74.4% of once-daily participants as improved on the Investigator Global Assessment scale.
Favorable Safety and Crossover Gains
Patients who crossed over from placebo to active treatment at Month 6 also realized meaningful benefits by Month 12.
The twice-daily crossover group added 32.1 hairs per square centimeter, while the once-daily group added 24.5 hairs.
Furthermore, 82.0% of twice-daily and 73.2% of once-daily crossover patients reported visible improvement.
VDPHL01 exhibited a favorable safety profile across 12 months, generating no treatment-related serious adverse events, no cardiac-related adverse events of special interest, and no treatment-emergent discontinuations between Month 6 and Month 12.
Having evaluated more than 1,000 male participants across registration studies, Veradermics expects female pattern hair loss trial data in the first half of 2027.
MANE Price Action: Veradermics shares were up 1.54% at $140.91 at the time of publication on Monday. The stock is trading near its 52-week high of $146.57, according to Benzinga Pro data.
Photo via Shutterstock
