Veradermics, Incorporated, a dermatologist-founded, late-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss, announced positive topline results from Part A of its randomized, double-blind, placebo-controlled Phase 2/3 clinical trial (Study ‘302’) evaluating VDPHL01, a proprietary extended-release oral minoxidil formulation, in over 500 males with mild-to-moderate pattern hair loss. Veradermics believes these results position VDPHL01 to potentially become the first FDA-approved oral pill in nearly 30 years for pattern hair loss and a potential best-in-indication treatment option for the 50 million men with pattern hair loss in the U.S.
Study ‘302’ enrolled 519 patients who were randomized to receive either VDPHL01 8.5mg once daily (QD), VDPHL01 8.5mg twice daily (BID), or placebo. The trial met all primary and all key secondary endpoints with statistical significance, demonstrating a potentially differentiated clinical profile defined by rapid onset of activity, consistent response across patients, and robust increases in hair count while being generally well tolerated with no treatment-related serious adverse events (SAEs) and no adverse events of special interest (AESIs) of cardiac origin.
In the study, VDPHL01 achieved superior hair growth compared with placebo (p<0.0001) on the co‑primary endpoints of non-vellus Target Area Hair Count (TAHC) and patient reported outcome (PRO) benefit of ‘improved’ or ‘much improved’ on the Androgenetic Alopecia Impact Rating Scale (AAIRS) at Month 6. Patients achieved an average increase in non-vellus hair count of 30.3 hairs/cm² (p<0.0001) and 33.0 hairs/cm² (p<0.0001) in once daily and twice daily VDPHL01 treatment arms, respectively. Those receiving placebo only showed a 7.3 hairs/cm² increase from baseline at Month 6.
Following 6 months of treatment with VDPHL01, 79.3% of patients in the once daily dose arm (p<0.0001) and 86.0% of patients in the twice daily dose arm (p<0.0001) reported improvement in hair coverage on the AAIRS versus 35.6% of placebo patients. Additionally, 48.4% of patients in the once daily dose arm (p<0.0001) and 62.9% of patients in the twice daily dose arm (p<0.0001) achieved ‘improved’ or ‘much improved’ hair coverage on the AAIRS compared to only 13.4% of placebo patients.
“Based on the results of the ‘302’ trial, VDPHL01, if approved, has the potential to transform how physicians and patients approach pattern hair loss for men,” said Dr. Maryanne Makredes Senna, board-certified dermatologist at Beth Israel Lahey Health, Assistant Professor of Dermatology at Harvard Medical School, and member of Veradermics’ scientific advisory board. “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.”
The consistency of clinically meaningful hair growth reported by patients was further supported by investigator perception of hair growth, with investigators grading 72.0% (QD; p<0.0001) and 84.4% (BID; p<0.0001) of male patients as having improved hair coverage at Month 6 (p<0.0001). Rapid onset of hair growth was also observed at the earliest measured time point measured in the trial, with statistically significant separation from placebo on TAHC and IGA as early as Month 2.
“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, M.D., Study ‘302’ trial investigator and board-certified dermatologist. “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.”
Treatment with VDPHL01 was generally well tolerated through Month 6 with overall treatment-emergent adverse event (TEAE) rates similar between VDPHL01 and placebo, and with an overall safety profile consistent with Phase 2. VDPHL01 demonstrated lower discontinuation rates than placebo, and the adverse event-related discontinuation rate was similar between active and placebo. No treatment-related SAEs and no AESIs of cardiac origin were observed in the study.
“Our proprietary, extended-release VDPHL01 formulation delivered marked increases in hair growth as assessed by objective assessments as well as physician and patient reports in Study ‘302’. These Phase 2/3 clinical study results support our belief that Veradermics’ novel formulation in VDPHL01 can optimize oral minoxidil for significant hair growth while minimizing side effects and cardiac risk,” said Reid Waldman, M.D., Chief Executive Officer of Veradermics. “With a formulation designed to deliver more consistent exposure and avoid peak concentrations associated with dose‑limiting cardiac side effects, we believe VDPHL01 has a potentially differentiated, generally well tolerated clinical profile with rapid, consistent, and robust hair growth. We are optimistic that these results represent a defining milestone for the hair loss community, our company and investors as we advance this foundational, non-hormonal treatment approach to the clinic for the millions of people with pattern hair loss.”
Study ‘302’ is part of an extensive pivotal development program designed to support the approval of VDPHL01 in both male and female pattern hair loss. In February, Veradermics announced enrollment completion in its second Phase 3 male trial, Study ‘304’, with topline results anticipated in the second half of 2026. Veradermics is actively recruiting female participants for its female pattern hair loss Phase 2/3 trial, Study ‘306’.
