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Jump to Key Points VDPHL01, an oral, extended-release formulation of minoxidil, successfully regrew hair in men with androgenetic alopecia over 6 months in a phase 3 trial, according to the product’s developer.
The company, Veradermics, announced efficacy and safety findings in a press release on October 19.
In the phase 3 study of 536 men with mild-to-moderate male pattern hair loss, patients were randomly assigned to receive VDPHL01 8.5 mg once daily, VDPHL01 8.5 mg twice daily, or placebo. Phase 2 data were released last year, as reported by Medscape Medical News.
In the phase 3 study, both the once-daily and twice-daily doses outperformed placebo (P < .0001) on both co-primary endpoints at 6 months: non-vellus Target Area Hair Count (TAHC) and the patient-reported measure of “improved” or “much improved” on the Androgenetic Alopecia Impact Rating Scale (AAIRS).
- Phase 3: oral ER minoxidil VDPHL01 improved androgenetic alopecia at 6 months.
- 536 men randomized: 8.5 mg QD, 8.5 mg BID, or placebo.
- Both doses beat placebo on TAHC + AAIRS co-primary endpoints (P<.0001).
- Mean non-vellus hair count ↑ 28.6/cm² QD; 36.4/cm² BID; placebo ↑ 6.6/cm².
- No treatment-related serious or cardiac adverse events; safety consistent with prior studies.
Participants achieved an average increase in non-vellus hair count of 28.6 hairs/cm2 (P < .0001) and 36.4 hairs/cm2 (P < .0001) in the once-daily and twice-daily arms, respectively. Those receiving placebo showed a 6.6 hairs/cm2 increase from baseline at 6 months.
Pooja Shah, MD, associate professor of dermatology at the Donald and Barbara Zucker School of Medicine at Hofstra University in Hempstead, New York, and director of dermatology at the Katz Institute for Women’s Health in New York, who was not affiliated with the study, said the new evidence could portend a major step forward in hair loss treatment.
“I’m not surprised by the results, and I think it’s exciting to see positive phase 3 data for an oral treatment for hair loss,” Shah told Medscape Medical News. “Dermatologists have been using low-dose oral minoxidil off-label for years with good results. However, the formulations we’ve traditionally used are immediate release, which can produce peak concentrations that may contribute to side effects in some patients.”
Shah observed that “one potential advantage of an extended-release formulation is that it may help reduce peak drug concentrations, which could influence the risk of certain side effects, such as dizziness or changes in blood pressure.”
The company also reported that 78.8% of participants in the once-daily arm (P < .0001) and 85% of participants in the twice-daily arm (P < .0001) at 6 months reported improvements in hair coverage on the AAIRS compared with 35.3% of those in the placebo arm. Additionally, 55.7% of the men in the once-daily dose arm and 68.7% of those in the twice-daily dose arm reported “improved” or “much improved” hair coverage compared with 15.0% of placebo participants(P < .0001 for both doses).
Blinded investigators in the study graded 78.4% (once daily; P < .0001) and 82.7% (twice daily; P < .0001) of participants as having improved hair coverage at month 6 (P < .0001) using the Investigator Global Assessment (IGA) scale. On TAHC, patient-reported outcomes, and IGA, some improvements were recorded as early as month 2.
VDPHL01 was generally well tolerated, Veradermics reported, with an overall safety profile consistent with previous studies. No treatment-related serious adverse events or cardiac-related adverse events of special interest were observed in the study.
The company expects to report new safety data in men through 12 months later this year, according to the release. A new study in female pattern hair loss is also fully enrolled, with data expected in 2027. In July, Veradermics released data from a small study on VDPHL01 in women.
The company did not provide information on plans to submit for FDA approval but noted in the release that VDPHL01 could become the first FDA-approved oral pill in nearly 30 years for pattern hair loss.
“If FDA approval comes through, this would be a valuable addition to our hair loss treatment arsenal,” Shah told Medscape Medical News.
“Right now, we have such limited options for hair loss,” she said. “So having additional therapies in our treatment bucket, backed by clinical trial data, is exciting for dermatologists. Hair loss can be challenging to treat, and not every patient responds adequately to a single treatment approach. The more options we have, the better positioned we are to personalize treatment and find an approach that works for each patient.”
Shah reported participating in an advisory board for Veradermics.
Scott Harris has covered dermatology for more than a decade. He lives near Washington, DC.
