Trial for First Oral Minoxidil for Female Hair Loss Initiates Phase 3

Key Takeaways

• VDPHL01 could become the first FDA-approved oral prescription therapy for female pattern hair loss (FPHL), according to a press release from Veradermics.

• The phase 2/3 trial aims to include over 500 women and is the first phase 3 oral hair loss study in this population.

• Final phase 2 data are expected in 2026.

Veradermics, Inc. announced the initiation of patient enrollment in a phase 2/3 registration-directed clinical trial of VDPHL01, a novel extended-release oral minoxidil formulation, according to a press release.

If approved, VDPHL01 could become a first-in-class oral therapy for women with female pattern hair loss (FPHL). The multicenter, randomized, double-blind trial (NCT07146022) seeks to enroll over 500 women and is the first phase 3 clinical investigation for an oral therapy in FPHL conducted in the United States. Veradermics said in the announcement that it is simultaneously conducting two additional phase 3 trials in both men and women, as well as a phase 2 open-label trial, with the female cohort now fully enrolled. 

“Women face a disproportionate emotional and psychological burden from hair loss, yet research and innovation have largely overlooked this group,” said Maryanne Makredes Senna, MD, a dermatologist at Beth Israel Lahey Health and assistant professor at Harvard Medical School, in the news release. “This trial marks a long-overdue step forward in addressing female hair loss with the clinical rigor it deserves.”

Final data from the phase 2 study are expected in 2026.

Source: Veradermics press release. November 18, 2025.