Phase 2/3 Trial of Extended-Release Oral Minoxidil Shows Robust Hair Growth Outcomes in Male Pattern Hair Loss

Veradermics recently announced positive topline results from Part A of Study '302', a randomized, double-blind, placebo-controlled phase 2/3 trial evaluating VDPHL01, a proprietary extended-release oral minoxidil tablet, in 519 adult men with mild to moderate androgenetic alopecia (AGA). The findings position VDPHL01 as a potential first-in-class FDA-approved oral therapy for pattern hair loss in nearly 3 decades.¹

“At Veradermics, we asked the question: Why is the best tool in our toolkit as dermatologists, a 40-year-old blood pressure medication that no one has aimed to optimize?” said Reid Waldman, MD, a dermatologist and chief executive officer of Veradermics, in a recent interview at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado.²

Study Design and End Points

Enrolled patients were randomized to VDPHL01 8.5 mg once daily, VDPHL01 8.5 mg twice daily, or placebo. The trial met both co-primary end points with statistical significance: non-vellus Target Area Hair Count (TAHC) and patient-reported improvement on the Androgenetic Alopecia Impact Rating Scale (AAIRS) at month 6.

Efficacy Outcomes

Patients in the once-daily and twice-daily arms achieved mean increases in non-vellus TAHC of 30.3 and 33.0 hairs/cm², respectively, compared to 7.3 hairs/cm² in the placebo group (p<0.0001 for both). On the AAIRS, 79.3% of once-daily patients and 86.0% of twice-daily patients reported any hair improvement, versus 35.6% in the placebo arm. Notably, 48.4% of once-daily and 62.9% of twice-daily patients achieved the higher threshold of "improved" or "much improved" ratings, compared to 13.4% for placebo.

Investigator Global Assessments (IGA) corroborated patient-reported outcomes, with investigators grading 72.0% of once-daily and 84.4% of twice-daily patients as having improved hair coverage. Statistically significant separation from placebo was observed as early as month 2 on both TAHC and IGA measures, supporting a rapid onset of action.

Safety and Tolerability

Treatment-emergent adverse event rates were comparable between the VDPHL01 arms and placebo. No treatment-related serious adverse events and no adverse events of special interest of cardiac origin were observed. Discontinuation rates were lower in the active treatment arms than in placebo, with adverse event-related discontinuation rates similar across groups.

Expert Commentary

"Dermatology has been treating hair loss with a drug borrowed from cardiology, in a formulation never intended for our patients, at doses we arrived at informally," said Michael Gold, MD, a Study '302' trial investigator and board-certified dermatologist, in the news release. "VDPHL01 is the first oral minoxidil formulation developed specifically for pattern hair loss, and now the first to generate positive Phase 3 results of efficacy and safety."

Maryanne Makredes Senna, assistant professor of dermatology at Harvard Medical School and a Veradermics scientific advisory board member, noted: "I believe that an oral therapy that has improved hair loss in the eyes of nearly 80% of patients and investigators, was generally well tolerated in trials and sits in a class that dermatologists are already comfortable prescribing, has the potential to transform the treatment landscape for male pattern hair loss."

Formulation and Development Pipeline

VDPHL01 utilizes a gel-matrix extended-release system designed to avoid the peak plasma concentrations associated with cardiac side effects seen with immediate-release oral minoxidil, while extending drug exposure above the minimum threshold required for hair growth stimulation. The compound is non-hormonal and, if approved, would represent the only FDA-approved oral non-hormonal AGA therapy for both men and women.

“Many people don't realize this, but minoxidil has no effect on the hair follicle itself. It has to be sulfated to minoxidil sulfate, and that sulfation can occur in the outer root sheath of the hair via the SULTA1A1 sulfate transfer. Now that enzyme, like many enzymes in our body, is capacity-limited, meaning it saturates and it's time-dependent, meaning it takes time to take minoxidil and turn it into the minoxidil sulfate,” Waldman said at AAD.²

He added, “If you think about the pharmacokinetics of that existing blood pressure medication, it spikes quickly. That overwhelms capacity. It saturates that enzyme, and it gives a very limited duration of exposure, meaning it doesn't give sufficient time to sulfate. Whereas if you think about the ability to keep that minoxidil at the follicle at optimal levels for a longer period of time, then you have the potential to drive the sulfation of the drug or drive the formation of the true active that drives hair growth. We believe that gives the potential to drive greater hair growth in a greater percentage of people.”

Part B of the development program includes Study '304' (second phase 3 male trial, topline data anticipated H2 2026) and Study '306' (currently enrolling females with AGA). Patent protection extends to at least 2043.

For more insights from Veradermics CEO Reid Waldman, MD, watch the video below.

References

1. Veradermics’ oral VDPHL01 achieved early, consistent, and robust hair growth in positive phase 2/3 ‘302’ clinical trial in male pattern hair loss. News release. Veradermics. April 27, 2026. Accessed April 27, 2026. https://ir.veradermics.com/news-releases/news-release-details/veradermics-oral-vdphl01-achieved-early-consistent-and-robust
2. Bunick CG, Waldman R. Executive insights: extended-release oral minoxidil shows optimized pharmacokinetics and potential to enhance hair growth. DermatologyTimes . March 29, 2026. Accessed April 27, 2026. https://www.dermatologytimes.com/view/executive-insights-extended-release-oral-minoxidil-shows-optimized-pharmacokinetics-and-potential-to-enhance-hair-growth