Twice-Daily VDPHL01 Adds 43.9 Hairs/cm² at One Year in Male Alopecia Trial

Twice-daily VDPHL01 increased mean non-vellus target area hair count by 43.9 hairs/cm² from baseline at month 12, the highest figure reported in Veradermics' phase 3 program to date. The 12-month topline results come from Study 302 (NCT06724614), a phase 2/3 trial of the investigational extended-release oral minoxidil in 519 men with mild-to-moderate androgenetic alopecia. Veradermics announced the data on November 9, 2026.

VDPHL01 is a proprietary extended-release oral formulation of minoxidil designed to sustain drug absorption while limiting the peak plasma concentrations linked to immediate-release versions. That property matters for oral minoxidil, which carries known cardiovascular considerations. The company reported no treatment-related serious adverse events, no adverse events of special interest of cardiac origin, and no new safety signals through 12 months.

How did the trial work?

Study 302 randomized 519 men to VDPHL01 8.5 mg once daily, 8.5 mg twice daily, or placebo for an initial 6-month placebo-controlled period. Placebo participants then crossed over to active treatment for the final 6 months, while treated participants continued their original regimens through month 12.

The twice-daily group built on its 6-month gains, rising from roughly 33 hairs/cm² at month 6 to 43.9 hairs/cm² at month 12. Once-daily recipients held steady, with 30.0 hairs/cm² at month 6 and 29.7 hairs/cm² at month 12. The data suggest hair density continues improving beyond the initial treatment period at the higher dose.

What did patients and investigators report?

Patient-reported outcomes tracked the hair-count findings. At month 12, 89.1% of twice-daily recipients and 79.8% of once-daily recipients reported visible improvement in hair coverage on the Androgenetic Alopecia Impact Rating Scale (AAIRS).

On global ratings, 68.0% of the twice-daily group and 48.4% of the once-daily group called their coverage improved or much improved. Investigators, using the Investigator Global Assessment scale, reported improved hair coverage in 92.2% of twice-daily recipients and 74.4% of once-daily recipients.

What happened after placebo crossover?

Participants who switched from placebo to VDPHL01 also gained hair. Mean non-vellus hair count rose 32.1 hairs/cm² in those crossing to twice-daily treatment and 24.5 hairs/cm² in those crossing to once-daily dosing by month 12.

Visible improvement in coverage was reported by 82.0% and 73.2% of the respective crossover groups, while 60.7% of twice-daily and 42.9% of once-daily crossover recipients rated coverage improved or much improved. The crossover design means no untreated placebo comparison remained in the second 6-month period, a limitation when interpreting those gains.

The crossover groups showed a safety profile comparable to the continuous-treatment cohorts. No treatment-emergent adverse events leading to discontinuation occurred between months 6 and 12 among participants continuing active treatment. Veradermics cautions the results remain preliminary, and full safety review will shape the long-term clinical profile.

Where does the program stand?

The 12-month data complete Veradermics' planned placebo-controlled efficacy assessments in men. The registration-directed program spans more than 1,600 participants across 3 studies in male and female pattern hair loss. In October 2026, the company reported positive topline results from Study 304, a separate phase 3 trial in 536 men that met its primary and secondary efficacy endpoints.

CEO Reid Waldman, MD, called the results an inflection point: "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."

VDPHL01 remains investigational and lacks FDA approval for pattern hair loss. Direct comparative trials would be needed to establish whether it beats existing options such as topical minoxidil or oral finasteride on efficacy or safety.

What comes next?

Veradermics is still recruiting the female side of the program. Study 306 (NCT07146022), a phase 2/3 trial of 556 women receiving 4.5-mg once-daily or twice-daily regimens, expects topline findings in the first half of 2027. The company hasn't said whether it will file for male pattern hair loss independently or wait for the female data.

For dermatologists, the 12-month findings point toward an eventual nonhormonal prescription oral option for patients who can't tolerate topical or hormonal therapies — pending regulatory review and complete clinical datasets.