Veradermics is enrolling women in its Phase 2/3 clinical trial of VDPHL01, an extended-release oral minoxidil treatment.
VDPHL01 holds the potential to be the first non-hormonal oral treatment designed specifically for hair regrowth in women and men and the first-ever oral prescription treatment for women with pattern hair loss.
The Phase 2/3 clinical trial is the only late-stage trial of its kind in women, and one of three multicenter, randomized, double-blind Phase 3 registration-directed trials of VDPHL01 in women and men with pattern hair loss. The company expects to enroll more than 500 women in the United States.
“For too long, women have shouldered a significant physical and emotional burden of hair loss. I’ve seen their distress firsthand—managing their confidence, anxiety, and shift in self-identity—while cycling through sub-optimal treatments, including over the counter, off-label, and topical formulations that have limitations in addressing the challenges of hair regrowth,” says Maryanne Makredes Senna, MD, a Dermatologist at Beth Israel Lahey Health, an Assistant Professor of Dermatology at Harvard Medical School in Boston, MA, and member of Veradermics’s scientific advisory board, in a news release. “The Phase 2/3 female trial of VDPHL01 represents a major milestone for the industry and for women—providing the clinical rigor long overdue in female-pattern hair loss. I’ve been encouraged by the early male data, and am hopeful that we are laying the foundation for an innovative, prescription oral treatment that, if approved, [is something that] patients and healthcare providers can more confidently count on.”
Ongoing Phase 2 Trial Female Cohort Fully Enrolled
Veradermics is also evaluating the safety and efficacy of VDPHL01 in an open-label, multi-dose Phase 2 trial in women and men with mild-to-moderate pattern hair loss who are not receiving any other active treatment. Enrollment in the female cohort is complete, and dosing is ongoing, with 22 women being studied over the course of 12 months. The trial’s primary endpoints include non-vellus target area hair count and patient-reported outcomes assessing the perceived effectiveness of VDPHL01.
The company recently announced encouraging preliminary VDPHL01 Phase 2 data in males that indicated visible and measurable hair growth as early as two months, with full results for both women and men anticipated in 2026.
For additional information about enrollment in the Phase 2/3 trial, visit www.phlstudy.com/female.
Bonus: A Closer Look at VDPHL01 With Dr. Neal Bhatia
Study Investigator Neal Bhatia, MD, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego, CA, discusses the preliminary data from the male cohort in an ongoing Phase 2 trial of Veradermics’s VDPHL01. The Company utilized a proprietary extended-release technology to develop VDPHL01, and this release profile is intended to enable fast, consistent, and intense hair growth, while avoiding concentration spikes above minoxidil’s identified cardiac activity threshold. Learn more about the study and Veradermics here.
