Veradermics Reports Sustained Hair Growth With VDPHL01 at 1 Year

Veradermics has announced positive 12-month topline results from its phase 2/3 Study 302 evaluating VDPHL01, an investigational extended-release oral formulation of minoxidil, in men with mild-to-moderate androgenetic alopecia. The findings demonstrated sustained hair growth through 1 year, including the highest target area hair count improvement reported in the company's phase 3 development program to date.¹

The results build on previously reported positive 6-month findings from Study 302 and the separate phase 3 Study 304, further supporting the investigational treatment's potential as a nonhormonal oral option for male pattern hair loss.

Study Design and 12-Month Efficacy

Study 302 (NCT06724614) enrolled 519 men with mild-to-moderate pattern hair loss who were randomized to receive VDPHL01 8.5 mg once daily, VDPHL01 8.5 mg twice daily, or placebo during an initial 6-month treatment period.

Following the placebo-controlled phase, participants originally assigned to placebo transitioned to active treatment for an additional 6 months. Participants receiving VDPHL01 continued their assigned dosing regimens through month 12.

Among participants receiving twice-daily VDPHL01 throughout the study, mean non-vellus target area hair count increased by 43.9 hairs/cm² from baseline at month 12, compared with approximately 33 hairs/cm² at month 6. The findings suggest continued improvement in hair density beyond the initial treatment period.

Participants receiving once-daily VDPHL01 maintained their initial improvements, with mean hair count increases of 30.0 hairs/cm² at month 6 and 29.7 hairs/cm² at month 12.

Patient-reported outcomes further supported the observed improvements. At month 12, 89.1% of participants receiving twice-daily treatment and 79.8% receiving once-daily treatment reported visible improvement in hair coverage on the Androgenetic Alopecia Impact Rating Scale (AAIRS).

Additionally, 68.0% and 48.4% of participants in the respective treatment groups rated their hair coverage as improved or much improved.

Investigator assessments were generally consistent with patient-reported findings. Using the Investigator Global Assessment scale, investigators reported improved hair coverage in 92.2% of twice-daily recipients and 74.4% of once-daily recipients.

Outcomes Following Placebo Crossover

Participants initially assigned to placebo also demonstrated improvements after transitioning to VDPHL01 for the final 6 months of the study.

At month 12, mean non-vellus hair count increased by 32.1 hairs/cm² among participants who transitioned to twice-daily treatment and 24.5 hairs/cm² among those receiving once-daily treatment.

Patient-reported visible improvement in hair coverage was observed in 82.0% and 73.2% of participants in the respective crossover groups. Furthermore, 60.7% of twice-daily recipients and 42.9% of once-daily recipients reported improved or much improved hair coverage.

These findings provide additional evidence of treatment-associated hair growth, although the crossover design means that no untreated placebo comparison remained during the second 6-month period.

Safety and Tolerability Through 12 Months

According to Veradermics, VDPHL01 maintained a generally favorable safety and tolerability profile throughout the 12-month evaluation, consistent with previously reported findings.

No treatment-related serious adverse events, adverse events of special interest of cardiac origin, or new safety signals were reported. Additionally, no treatment-emergent adverse events leading to discontinuation occurred between months 6 and 12 among participants continuing active treatment.

Participants who transitioned from placebo to VDPHL01 demonstrated a safety profile comparable to that observed in the continuous-treatment groups.

The findings are particularly relevant given the cardiovascular considerations associated with oral minoxidil. VDPHL01 uses a proprietary extended-release formulation designed to provide sustained drug absorption while limiting the peak concentrations associated with immediate-release formulations.

However, the results remain preliminary, and additional review of complete safety data will be important in determining the treatment's long-term clinical profile.

Implications for the Androgenetic Alopecia Treatment Landscape

The latest findings represent another milestone in Veradermics' registration-directed development program, which includes more than 1,600 participants across 3 studies evaluating VDPHL01 in male and female pattern hair loss.

In October 2026, the company reported positive topline results from Study 304, a separate phase 3 trial involving 536 men, which met its primary and secondary efficacy endpoints.

Together, the male studies provide a growing evidence base for VDPHL01 as a potential prescription treatment for androgenetic alopecia.

“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,” said Reid Waldman, MD, chief executive officer of Veradermics, in the company announcement.¹

Although the findings suggest clinically meaningful improvements in hair count and patient-perceived coverage, direct comparative studies would be necessary to establish whether VDPHL01 offers superior efficacy or safety relative to existing treatments such as topical minoxidil or oral finasteride.

VDPHL01 remains investigational and has not received FDA approval for pattern hair loss.

Looking Ahead

With positive topline findings from Studies 302 and 304, Veradermics has completed its planned placebo-controlled efficacy assessments in men with pattern hair loss.

The company is also evaluating VDPHL01 in women through Study 306 (NCT07146022), a phase 2/3 trial involving 556 participants receiving 4.5-mg once-daily or twice-daily regimens. Topline findings are anticipated in the first half of 2027.

The company has not yet confirmed whether it will pursue regulatory approval for male pattern hair loss independently or await additional results from its female development program.

For dermatologists, the 12-month findings suggest that extended-release oral minoxidil could eventually expand treatment options for patients seeking alternatives to existing topical or hormonal therapies. Further regulatory evaluation and complete clinical data will be needed to establish its place in the treatment landscape.

References

1. Veradermics. Veradermics achieved the highest VDPHL01 reported hair count in the phase 3 program to date in positive 12-month Study '302' data in male pattern hair loss. News release. November 9, 2026. https://veradermics.gcs-web.com/news-releases/news-release-details/veradermics-achieved-highest-vdphl01-reported-hair-count-phase-3
2. Coffey D. Veradermics wraps phase 3 program in men with 'better-than-expected' hair growth at 1 year. Fierce Pharma. November 9, 2026. https://www.fiercepharma.com/pharma/veradermics-wraps-phase-3-program-men-better-expected-hair-growth-1-year
3. Veradermics. Veradermics reports third quarter 2026 financial results and highlights recent corporate and clinical progress. News release. November 10, 2026. https://www.businesswire.com/news/home/20261110316485/en/Veradermics-Reports-Third-Quarter-2026-Financial-Results-and-Highlights-Recent-Corporate-and-Clinical-Progress