Veradermics reports positive Phase 3 results for oral VDPHL01, with improved hair count and patient-reported coverage versus placebo at six months.
Written By: Aasritha Thippavajjala, PharmD
Reviewed By: Pharmacally Editorial Team
Veradermics reported positive topline results on October 19, 2026, from Study 304, a Phase 3 trial evaluating VDPHL01, an investigational extended-release oral formulation of minoxidil, in men with mild-to-moderate pattern hair loss. Both once-daily and twice-daily regimens met the trial’s co-primary endpoints at Month 6, supporting further development of the formulation.
Study Design and Endpoints
Study 304 (NCT06972264) was a randomized, double-blind, placebo-controlled trial involving 536 men assigned to VDPHL01 8.5 mg once daily, VDPHL01 8.5 mg twice daily, or placebo. The 52-week study included a six-month placebo-controlled period followed by a six-month extension during which all participants receive VDPHL01. The announced results cover the initial six-month period.
The co-primary endpoints were change from baseline in non-vellus target-area hair count and the proportion of participants reporting “improved” or “much improved” hair coverage on the Androgenetic Alopecia Impact Rating Scale (AAIRS), a patient-reported outcome measure.
Hair Count and Patient-Reported Improvement
At Month 6, mean non-vellus target-area hair count increased by 28.6 hairs/cm² with once-daily treatment and 36.4 hairs/cm² with twice-daily treatment, compared with 6.6 hairs/cm² with placebo. Both comparisons were statistically significant (p<0.0001).
For the patient-reported co-primary endpoint, 55.7% of participants receiving once-daily treatment and 68.7% receiving twice-daily treatment reported “improved” or “much improved” hair coverage, compared with 15.0% in the placebo group (both p<0.0001).
For the broader category of any reported improvement in coverage, response rates were 78.8%, 85.0%, and 35.3%, respectively. Investigators separately rated hair coverage as improved in 78.4% of participants receiving once-daily treatment and 82.7% receiving twice-daily treatment. Both comparisons were statistically significant versus placebo (p<0.0001).
Although the numerical results favored twice-daily dosing, the reported findings do not establish its statistical superiority over once-daily treatment.
Early Response and Safety Findings
Veradermics reported statistically significant separation from placebo in hair count, patient-reported outcomes, and investigator assessments by Month 2, the earliest assessment point. The announcement did not provide effect sizes for this time point.
The company described VDPHL01 as generally well tolerated through Month 6, reporting no treatment-related serious adverse events and no adverse events of special interest of cardiac origin.
Peripheral edema occurred in 2.8% of participants receiving once-daily treatment, 4.5% receiving twice-daily treatment, and 0.6% receiving placebo. Hypertrichosis, or excess hair growth, occurred in 2.2%, 9.0%, and 0%, respectively.
Peripheral edema and hypertrichosis each led to treatment discontinuation in 0% of participants receiving once-daily treatment, 0.6% receiving twice-daily treatment, and 0% receiving placebo.
These findings provide an initial six-month safety assessment. The absence of reported cardiac adverse events of special interest during this period does not establish long-term cardiovascular safety.
Supporting Results and Development Outlook
In the separate Phase 2/3 Study 302, which enrolled 519 men, mean non-vellus hair count increased by 30.3 hairs/cm² with once-daily treatment and 33.0 hairs/cm² with twice-daily treatment, compared with 7.3 hairs/cm² with placebo. The proportions reporting “improved” or “much improved” hair coverage were 48.4%, 62.9%, and 13.4%, respectively.
The findings provide additional evidence of activity across two placebo-controlled studies. However, comparisons between Studies 302 and 304 are descriptive and do not establish head-to-head superiority.
Veradermics expects 12-month data from Study 302 later in 2026. Topline results from Study 306, a Phase 2/3 trial evaluating VDPHL01 in women with female pattern hair loss, are anticipated in the first half of 2027.
Clinical Interpretation
Subtracting the placebo-group mean change from the corresponding active-treatment results in Study 304 gives calculated differences of 22.0 hairs/cm² for once-daily treatment and 29.8 hairs/cm² for twice-daily treatment. These are arithmetic differences derived from reported group means, not company-reported adjusted treatment effects.
The results suggest that VDPHL01 can improve target-area hair count and patient-reported coverage over six months in men with pattern hair loss. However, the topline announcement does not provide the complete statistical analysis, including confidence intervals for these calculated differences, or establish the comparative superiority of either regimen.
Further assessment of the full clinical dataset, the patient-reported outcome measure, and longer-term efficacy and safety will be important in defining the treatment’s potential clinical role. VDPHL01 remains investigational and is not FDA-approved for pattern hair loss.
References
Veradermics. Veradermics’ Oral VDPHL01 Achieved Early, Consistent, and Robust Hair Growth in Positive Phase 3 ‘304’ Clinical Trial in Male Pattern Hair Loss. October 19, 2026.
ClinicalTrials.gov. Study of VDPHL01 in Male Participants with Pattern Hair Loss. NCT06972264.
About the Writer
Aasritha Thippavajjala (Linkedin) is a pharm D student and aspiring medical writer with medical writing, clinical training experience and a strong interest in clinical research and patient safety She has hands-on exposure to clinical pharmacy activities including medication profile assessment, clinical case review, identification of potential drug-related problems, ADR awareness, patient counselling, and clinical documentation. She has also gained experience in medical literature review, evidence synthesis, and scientific communication through her published review article on digital twin-based patient simulation and her poster presentation at the 74th Indian Pharmaceutical Congress. Certified in ICH Good Clinical Practice (E6(R3)) and Scientific Writing in Health Research, she is passionate about applying her clinical knowledge and research skills to medical writing ,clinical research and contributing to accurate, evidence-based healthcare.