Oral VDPHL01 Shows Robust Hair Growth in Phase 3 Male Pattern Hair Loss Trial

Veradermics moves a step closer to the first new FDA-approved prescription hair loss drug in nearly 30 years.

On October 19, 2026, Veradermics announced positive topline results from its Phase 3 “304” trial, reporting that its oral drug VDPHL01 produced early, consistent, and robust hair growth in men with male pattern hair loss. The dermatologist-founded biopharmaceutical company said the extended-release minoxidil tablet met all primary and secondary endpoints with high statistical significance in both its once-daily and twice-daily dosing arms.

The findings strengthen the case for VDPHL01 to become the first FDA-approved non-hormonal oral treatment for pattern hair loss, a condition that affects an estimated 50 million men in the U.S. and has seen no new FDA-approved prescription medicine in nearly 30 years.

What is VDPHL01?

VDPHL01 is an investigational, orally administered extended-release formulation of minoxidil, a long-established hair-growth agent available topically and, more recently, in off-label oral form. Veradermics built the tablet around a gel matrix designed to release minoxidil steadily, avoiding the high peak concentrations of immediate-release oral minoxidil while keeping drug levels above the threshold needed to stimulate hair growth.

The company says this approach is intended to maximize minoxidil’s benefit while minimizing cardiac risk. Because it is non-hormonal, VDPHL01 works differently from finasteride and is being developed for both men and women.

Understanding the Phase 3 “304” trial

Study ‘304’ was a randomized, double-blind, placebo-controlled Phase 3 trial that enrolled 536 men with mild-to-moderate pattern hair loss, randomized to VDPHL01 8.5 mg once daily (QD), 8.5 mg twice daily (BID), or placebo. The topline data cover the six-month, placebo-controlled portion of a 52-week design, after which all participants continue into an extension phase on active drug.

The co-primary endpoints were the change from baseline in non-vellus target area hair count (TAHC) and the proportion of participants reporting “improved” or “much improved” hair coverage on a patient-reported scale. Investigator Global Assessment (IGA) was a key secondary measure. The trial met all of them.

Key Results: Measurable and Visible Hair Growth

At Month 6, men taking VDPHL01 saw substantially more hair growth than those on placebo:

• Hair count rose by 28.6 hairs/cm² with once-daily dosing and 36.4 hairs/cm² with twice-daily dosing, versus just 6.6 hairs/cm² for placebo (both p<0.0001).
• 55.7% (QD) and 68.7% (BID) of participants rated their hair as “improved” or “much improved,” compared with 15% on placebo.
• Counting any visible improvement, 78.8% (QD) and 85% (BID) of treated men reported progress, versus 35.3% on placebo.
• Investigators graded hair coverage as improved in 78.4% (QD) and 82.7% (BID) of treated participants.

Notably, VDPHL01 separated statistically from placebo as early as two months — the first time point measured — across hair count, patient-reported outcomes, and investigator assessment, pointing to an early onset of effect. The hair-count gains closely mirrored those from the company's earlier Study '302'.

Safety and Tolerability

Across more than 1,000 participants in two registration-directed studies, VDPHL01 was generally well tolerated, with no new safety signals in Study ‘304.’ The company reported no treatment-related serious adverse events and no adverse events of special interest of cardiac origin. The most commonly reported side effects were peripheral edema (fluid retention) and hypertrichosis (excess hair growth), both more frequent with twice-daily dosing, a known effect associated with minoxidil.

What’s Next

VDPHL01 is the lead program in a development effort spanning more than 1,600 men and women. Veradermics expects longer-term, 12-month safety data from Part B of Study ‘302’ later this year and topline results from Study ‘306’ — described as the first registration-directed U.S. trial of an oral therapy specifically for female pattern hair loss — in the first half of 2027.

“Based on these results, we believe VDPHL01 has the potential to transform the treatment of pattern hair loss for millions of people,” said Reid Waldman, M.D., Veradermics’ chief executive officer.

Antonella Tosti, M.D., a dermatology professor at the University of Miami, added that the consistency across the two trials and the rigor of the hair-growth assessments “give me confidence in these results,” and said the drug “has the potential to become the new standard of care for male pattern hair loss, if approved.”

These are topline, company-reported results that have not yet been peer-reviewed or evaluated by the FDA, and VDPHL01 remains an investigational drug.