Veradermics reported positive Phase 2 results for VDPHL01 in female pattern hair loss, showing rapid hair growth, improved coverage, and favorable safety.
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
Veradermics has reported positive topline results from the open-label Phase 2 Study 207 (NCT06527365) evaluating VDPHL01, an investigational extended-release oral minoxidil formulation, in women with mild-to-moderate female pattern hair loss. The study showed rapid improvements in hair growth, consistent treatment responses over six months, and a favorable safety profile, reinforcing the drug’s potential to become the first FDA-approved oral prescription therapy for female pattern hair loss.
Female participants received either VDPHL01 4.5 mg once daily or 4.5 mg twice daily for six months. Both dosing regimens achieved clinically meaningful improvements in hair density and patient-reported outcomes without treatment-related serious adverse events or cardiac adverse events of special interest.
Extended-Release Oral Minoxidil Targets an Unmet Need
Pattern hair loss, also known as androgenetic alopecia, affects an estimated 30 million women and 50 million men in the United States. Although topical minoxidil remains widely available, there are currently no FDA-approved oral prescription therapies specifically indicated for female pattern hair loss.
VDPHL01 is an investigational extended-release minoxidil tablet that delivers sustained drug exposure while avoiding the high peak concentrations associated with immediate-release oral minoxidil. The formulation is intended to improve efficacy while supporting a favorable safety profile. If approved, it could become the first FDA-approved oral non-hormonal treatment for pattern hair loss in both women and men.
Phase 2 Study Demonstrated Early and Sustained Hair Growth
Study 207 was a multicenter, open-label Phase 2 trial that enrolled 28 women with pattern hair loss. The primary objective was to evaluate the safety and proof of concept for oral VDPHL01 over a 12-month treatment period, with six-month topline results now available.
At Month 6, women receiving once-daily VDPHL01 achieved a mean increase of 22.7 non-vellus hairs/cm², while twice-daily dosing produced a 23.3 hairs/cm² increase.
Patient-reported outcomes also favored treatment. Using the Androgenetic Alopecia Impact Rating Scale (AAIRS), 88.9% of women receiving once-daily treatment and 90.0% receiving twice-daily treatment rated their hair coverage as “improved” or “much improved” after six months.
Investigators similarly reported improvements in hair coverage in 100% of participants in the once-daily arm and 90% in the twice-daily arm at Month 6.
Hair growth appeared early during treatment. By Month 2, investigators observed improvement in 67.2% of participants, while 63.2% of patients reported noticeable improvement in hair coverage.
Safety findings remained consistent with previous VDPHL01 studies. Investigators reported no treatment-related serious adverse events and no cardiac adverse events of special interest, supporting the extended-release formulation’s tolerability.
Results Strengthen Confidence in Pivotal Development Program
Commenting on the findings, dermatologist Dr. Jerry Shapiro said the results address a long-standing treatment gap for women with pattern hair loss, who currently rely primarily on topical therapies and supplements with inconsistent benefits. He noted that the Phase 2 data position VDPHL01 as a potential first FDA-approved oral therapy for this patient population.
Veradermics Chief Executive Officer Reid Waldman, M.D., said the study provides strong proof of concept using the same efficacy endpoints being evaluated in the company’s ongoing registration-directed Phase 2/3 female trial, increasing confidence ahead of the next major clinical readout.
Regulatory Path Forward
Veradermics is advancing VDPHL01 through multiple late-stage clinical studies in both female and male pattern hair loss.
The company is actively enrolling participants into Study 306, its registration-directed Phase 2/3 trial in female pattern hair loss, with topline results expected in the first half of 2027. In male pattern hair loss, the company previously reported positive topline results from Study 302, while Study 304, a second Phase 3 trial, completed enrollment and is expected to report topline data during the second half of 2026. If these studies confirm the current findings, VDPHL01 could become the first FDA-approved oral treatment option for women with pattern hair loss and expand treatment choices for millions of patients.
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About the Writer
Farha Farheen, PharmD (LinkedIn) is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.