Extended-Release Minoxidil Trial
Veradermics reported 12-month trial data for its investigational extended-release oral minoxidil treatment, VDPHL01, showing increased hair counts in men with pattern hair loss, Dermatology Times reported.
At the 12-month mark, mean non-vellus hair count grew by 32.1 hairs per square centimeter for participants who shifted to twice-daily dosing. Those staying on once-daily treatment gained 24.5 hairs per square centimeter.
Patient-Reported Coverage Results
Patient surveys tracked visible changes in hair coverage across the crossover groups. Visible improvements showed up in 82.0% of twice-daily recipients and 73.2% of once-daily participants.
Improved or much improved hair coverage was reported by 60.7% of the twice-daily group. Only 42.9% of the once-daily group reported the same high level of change.
The crossover trial design left no untreated placebo comparison active during the second six-month stretch.
Safety Profile Updates
VDPHL01 maintained a generally favorable safety and tolerability profile through 12 months, according to company statements. No treatment-related serious adverse events or cardiac issues popped up during the evaluation.
No participants stopped treatment due to adverse events between months 6 and 12. Patients switching from placebo to the active drug reported safety results matching continuous-treatment groups.
The extended-release formulation aims to limit peak drug concentrations tied to immediate-release oral minoxidil. Safety officials continue reviewing data to confirm the long-term clinical profile.
Clinical Development Milestones
The 12-month data mark another step in a registration-directed program involving more than 1,600 participants. Study 304 reported positive topline results in October 2026 for a separate phase 3 trial of 536 men.
The 12-month long-term data from Study 302 represent an important milestone in our efforts to provide a new standard of care for male pattern hair loss,
Reid Waldman, MD, chief executive officer of Veradermics, said in the company announcement.
Direct comparative studies against existing treatments like topical minoxidil or oral finasteride have not yet been conducted. VDPHL01 remains an investigational drug without FDA approval for pattern hair loss.
Female Trial Evaluation
Veradermics is currently testing VDPHL01 in women through Study 306, a phase 2/3 trial involving 556 participants. That trial evaluates 4.5-mg once-daily or twice-daily regimens, with topline findings anticipated in the first half of 2027.
Company executives have not clarified whether they will seek regulatory approval for male pattern hair loss independently. Dermatologists continue to watch trial results as a potential future alternative to topical therapies.
What Is VDPHL01, Study 304, and Female Trial Timelines?
What is VDPHL01?
VDPHL01 is an investigational proprietary extended-release oral minoxidil formulation developed by Veradermics for male and female pattern hair loss.
How many participants were in Study 304?
Study 304 was a separate phase 3 trial involving 536 men that met its primary and secondary efficacy endpoints in October 2026.
When are female trial results expected?
Topline findings from Study 306, a phase 2/3 trial involving 556 female participants, are anticipated in the first half of 2027.
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