Phase 2 Trial Supports Oral VDPHL01 for Female Pattern Hair Loss

Veradermics, Incorporated (NYSE: MANE) announced positive topline results from the phase 2 open-label Study '207' evaluating investigational extended-release oral minoxidil (VDPHL01) in women with mild-to-moderate pattern hair loss.¹ At 6 months, treatment increased non-vellus target area hair counts (TAHC) by more than 22 hairs/cm² and was associated with patient-reported improvement rates approaching 90%.¹

Study '207' is a multicenter, phase 2, open-label trial (NCT06527365) that enrolled 21 men and 28 women with mild-to-moderate pattern hair loss.¹ Women received VDPHL01 4.5 mg once daily or twice daily for up to 12 months, with the current analysis reporting 6-month outcomes.¹ Primary efficacy assessments included changes in non-vellus TAHC and patient-reported outcomes measured using the Androgenetic Alopecia Impact Rating Scale (AAIRS).¹

No FDA-approved oral prescription treatment currently exists for female pattern hair loss, and no new prescription therapies for the condition have reached the market in nearly 30 years.¹ VDPHL01 is designed to maintain minoxidil concentrations above the threshold believed necessary for hair growth while reducing the peak plasma concentrations associated with immediate-release oral formulations.¹

Efficacy Findings

At Month 6, mean non-vellus TAHC increased by 22.7 hairs/cm in the once-daily arm and 23.3 hairs/cm in the twice-daily arm.¹ On the AAIRS, 88.9% of participants receiving once-daily dosing and 90.0% receiving twice-daily dosing reported their hair coverage as "improved" or "much improved."¹ Investigator assessments aligned with patient-reported outcomes, with improvement observed in 100% of participants in the once-daily group and 90% of those in the twice-daily group.¹

Improvement was evident by Month 2, the earliest assessed time point, when investigators rated 67.2% of participants as improved and 63.2% of participants reported improvement themselves.¹

Safety and Tolerability

VDPHL01 was generally well tolerated through Month 6, with no treatment-related serious adverse events or cardiac adverse events of special interest reported among female participants.¹ The company reported no new safety signals during the study.¹

According to Veradermics, the extended-release formulation is intended to reduce the high peak plasma concentrations associated with immediate-release oral minoxidil while maintaining drug exposure sufficient to promote hair growth.¹

Jerry Shapiro, MD, professor of dermatology and director of the Hair Clinic at NYU Langone Medical School and a paid consultant to Veradermics, said, "Female pattern hair loss has long been underserved with no FDA-approved oral prescription treatment options and limited clinical research."¹

Reid Waldman, MD, chief executive officer of Veradermics, said the findings strengthen the company's confidence as VDPHL01 advances into the ongoing registration-directed Study '306'.¹

VDPHL01 is being investigated as a potential oral, nonhormonal treatment for pattern hair loss in both women and men. Veradermics expects topline results from the female registration-directed Study '306' in the first half of 2027 and from the male phase 3 Study '304' in the second half of 2026.¹

References:

1. Veradermics' oral VDPHL01 delivers positive Study '207' phase 2 clinical trial results in female pattern hair loss ahead of upcoming phase 2/3 Study '306' readout. News release. Veradermics, Incorporated. July 15, 2026. Accessed July 15, 2026. https://www.businesswire.com/news/home/20260715636372/en/Veradermics-Oral-VDPHL01-Delivers-Positive-Study-207-Phase-2-Clinical-Trial-Results-in-Female-Pattern-Hair-Loss-Ahead-of-Upcoming-Phase-23-Study-306-Readout