Sustained 1-Year Efficacy Seen with Clascoterone for Androgenetic Alopecia, With Maria Hordinsky, MD

Cosmo Pharmaceuticals announced positive 12-month phase 3 findings on clascoterone 5% topical solution in men with mild-to-moderate androgenetic alopecia (AGA), noting the treatment’s sustained efficacy with continued use.1,2

These data highlighting the success of the drug in recent phase 3 clinical trials were discussed by trial investigator Maria Hordinsky, MD, an R.W. Goltz professor of dermatology at the University of Minnesota, who emphasized the significance of the results from both clinical and patient perspectives. The trial program was described as the largest phase 3 program ever done for a topical treatment of androgenetic alopecia in males, with 1465 patients recruited across 51 sites in US and Europe.

“There hasn't been a new FDA…medical treatment, for over 30 years,” Hordinsky noted. “It's been a long time since something has come to this point with with the current medication. We now have the opportunity to really use a topical agent that targets the androgen receptor, one of the key players in androgenetic alopecia.”

In Hordinsky’s view, this positions clascoterone as a potentially important addition to the treatment armamentarium. As a topical androgen receptor inhibitor, the therapy directly targets a key driver of AGA, providing a novel mechanism of action compared to existing choices among patients suffering from such hair loss conditions. She highlighted the clinical relevance of the sustained efficacy observed between Months 6 - 12, describing the continued improvement over time as exciting.

Although she expressed interest in seeing longer-term durability data in real-world settings, Hordinsky underscored these 12-month findings, already, show meaningful persistence of benefit for those with AGA. With regard to the reported 239% relative improvement in target area hair count (TAHC), she stressed while numerical metrics are important, perception among patients also remains central. Hair counts rising can translate into visible, tangible shifts for those with hair loss, aligning clinical outcomes with real-world expectations of improved hair appearance and density.

The trial design, which involved a comparison between subjects on clascoterone and those shifted to vehicle following 6 months, additionally reinforced the value of ongoing use. Those who discontinued active treatment reported a gradual loss of benefit, suggesting consistent use may be necessary to maintain the positive results. Looking ahead, Hordinsky noted clascoterone would likely fit well into a growing and increasingly personalized AGA treatment landscape.

For more information on these data, view the full video interview posted above.

Hordinsky has served on an advisory board for AbbVie (fees) and as an investigator receiving grants or research funding from Arcutis Biotherapeutics, Cassiopea, Concert Pharmaceuticals, Eli Lilly and Company, National Alopecia Areata Foundation, RegenLab, and Sun Pharmaceuticals. She has also received fees for other work with UpToDate, Inc.

References

1. Phase III 12-Month Data for Clascoterone 5% Topical Solution Confirm Positive Safety for Chronic Use and Continued Hair Growth, both of which Are Statistically Significant. Cosmo Pharmaceuticals. April 15, 2026. Accessed April 20, 2026. https://www.cosmohealthconfidence.com/news/98958067-clascoterone-12-month-safety-results-ende.

2. Hordinsky M. Phase 3 SCALP Study on Clascoterone for Androgenetic Alopecia, With Maria Hordinsky, MD. HCPLive. December 18, 2025. Accessed April 20, 2026. https://www.hcplive.com/view/phase-3-scalp-study-clascoterone-androgenetic-alopecia-maria-hordinsky-md.