In newly released data from a small phase 2, open-label trial, an extended-release formulation of minoxidil was associated with “improved” or “much improved” hair regrowth over a period of 6 months in approximately 90% of women with androgenetic alopecia.

The 6-month results of the drug, known as VDPHL01, in the 28 female participants in the phase 2 trial were announced by the manufacturer, Veradermics. The 2- and 4-month results in the 21 male participants, who were enrolled first, were announced in October 2025.

On Rating Scale, 90% of Patients Improved

In the study, the 28 women were randomized to 4.5 mg oral VDPHL01 once or twice a day. At 6 months, an improved or much improved response on the Androgenetic Alopecia Impact Rating Scale was achieved in 88.9% of those in the once-daily arm and 90% of those in the twice-daily arm.

Like the male participants, of whom 55% had achieved improved or much improved hair coverage within the first 2 months of treatment, improvement at 2 months was graded meaningful in 67.2% of women as judged by investigators and 63.2% as judged by participants, and the 6-month results confirmed further hair regrowth, according to Veradermics.

At 6 months, average increases in the non-vellus hair count from baseline were 23.3 hairs/cm² and 22.7 hairs/cm² in the twice-daily and once-daily groups, respectively.

The extended-release formulation of minoxidil has been well tolerated in all participants in clinical studies so far, and there have been no serious adverse events with no signal of cardiovascular adverse events, according to the company.

Low-dose oral minoxidil, an antihypertensive, has been widely used off label for treating hair loss. A topical formulation of minoxidil is approved for the treatment of androgenetic alopecia in both men and women.

Phase 2/3 trials have been initiated in both men and women. Results of phase 2/3 trial data in men were released by the manufacturer in April 2026. At 6 months, 79.3% of the men randomized to the once-daily dose and 86% on the twice-daily dose vs about 36% of those on placebo had improvement on the basis of patient-reported outcomes.

Phase 2/3 results in women are anticipated in the first half of 2027, according to a Veradermics spokesperson.

For female-pattern alopecia, these phase 2 results are potentially meaningful, according to Maryanne Makredes Senna, MD, who specializes in hair disorders at the Lahey Clinic in Burlington, Massachusetts, and is an assistant professor of dermatology at Harvard University School of Medicine in Boston.

“These data are highly encouraging, particularly given the limited treatment options currently available for women with hair thinning,” said Senna, who was not involved in this study but is a consultant for Veradermics. Beyond the improvement in non-vellus hair counts, she called patient perception of improvement with available therapies “uncommon.”

“The visible improvement noted by 63%-67% of both patients and investigators as early as 2 months is especially notable,” she told Medscape Medical News. “This rapid onset of benefit compares favorably with current treatments, which often require 6 months or longer before meaningful results are seen.”

Shapiro reported a financial relationship with Veradermics, which is developing VPDHL01. Senna reported having financial relationships with Arena, Cassiopea, Concert, Deciphera, Follica, Lilly, Pfizer, and Veradermics.

Ted Bosworth, a career medical writer based in New York City, has been covering advances in clinical medicine, including dermatology and oncology, for several decades.