Oral VDPHL01 Delivers Rapid, Robust Hair Growth in Phase 2/3 Trial for Male Pattern Hair Loss
Veradermics’ investigational oral therapy VDPHL01 demonstrated strong efficacy and early onset of action in male pattern hair loss, according to a phase 2/3 clinical trial press release, marking a potential breakthrough in a field with limited innovation over the past decades.
Speaking with The Dermatologist, Dr Michael H. Gold, trial investigator and board-certified dermatologist, said, “With this announcement, we are all excited to see such positive results for Veradermics' oral VDPHL01, which could be the first US Food and Drug Administration (FDA)-approved prescription medicine for pattern hair loss in men. Pattern hair loss is a very large market and perhaps the largest market in dermatology that has not had new FDA-approved medicines in nearly 30 years.”
The randomized, double-blind, placebo-controlled Study ‘302’ enrolled 519 men with mild-to-moderate pattern hair loss. Patients received VDPHL01 8.5 mg once daily, twice daily, or placebo over 6 months. The co-primary endpoints included changes in non-vellus target area hair count (TAHC) and patient-reported outcomes using the Androgenetic Alopecia Impact Rating Scale.
VDPHL01 demonstrated robust hair growth compared with placebo. At month 6, mean increases in TAHC reached 30.3 hairs/cm² (once daily) and 33.0 hairs/cm² (twice daily), compared with 7.3 hairs/cm² for placebo (P<0.0001 for both comparisons).
“VDPHL01, a novel orally administered extended-release minoxidil formulation, met all primary and all key secondary endpoints with high statistical significance in both active treatment arms,” the company reported, highlighting consistent results across once-daily and twice-daily dosing regimens.
Clinical benefits were also reflected in patient-reported outcomes. Approximately 79.3% (once daily) and 86.0% (twice daily) of patients reported improvement in hair coverage vs 35.6% of placebo-treated patients. Additionally, up to 62.9% of treated patients reported “improved” or “much improved” outcomes compared with just 13.4% in the placebo group.
Importantly, treatment effects emerged early. “Statistically significant improvement in hair growth was observed at month 2, the earliest time point evaluated,” according to the press release, underscoring the rapid onset of action. Safety findings were favorable, with “overall adverse event rates similar to placebo” and no treatment-related serious adverse events or cardiac safety signals reported.
“The extended-release oral minoxidil that we are studying has showed safety and efficacy, as well as results in many starting as early as 2 months. We all are excited to see what the 12-month data show and then how this drug performs in female pattern hair loss. That trial is also underway and, if approved, would be the first oral FDA-approved medicine for women experiencing pattern hair loss,” said Dr Gold.
These results position VDPHL01 as a potential first-in-class, FDA-approved oral non-hormonal therapy for pattern hair loss, with ongoing studies expected to further define its role in both male and female populations.
Reference
Veradermics’ oral VDPHL01 achieved early, consistent, and robust hair growth in positive phase 2/3 ‘302’ clinical trial in male pattern hair loss. Press release. April 27, 2026. https://ir.veradermics.com/news-releases/news-release-details/veradermics-oral-vdphl01-achieved-early-consistent-and-robust
