Topical anti-androgen drug improves male pattern baldness

Key takeaways:

• Clascoterone 5% topical solution targets the androgen receptor in the hair follicle without measurable systemic absorption.
• Topline data show the drug improved target area hair count up to 539% vs. vehicle.

Clascoterone 5%, a topical anti-androgen drug indicated for male pattern hair loss, demonstrated significant hair regrowth growth vs. vehicle at 6 months without the risks of oral therapies, according to a press release.

Clascoterone 5% topical solution (Cosmo Pharmaceuticals) is an investigational treatment developed specifically for androgenetic alopecia. The drug blocks dihydrotestosterone directly at the hair-follicle receptor without systemic absorption. Clascoterone 1% cream (Winlevi, Sun Pharmaceuticals) is already approved as a topical acne treatment, with more than 1.5 million prescriptions in the U.S. since its launch in 2020.

Cosmo called the topline results the “first major therapeutic breakthrough in hair-loss treatment in more than 3 decades,” according to the release.

“Clascoterone 5% topical solution is a completely new therapeutic approach to treating androgenic alopecia,” Maria Hordinsky, MD, the R.W Goltz Professor of Dermatology at the University of Minnesota, told Healio. “Unlike existing treatments for androgenic alopecia, clascoterone 5% topical solution targets the androgen receptor locally in the hair follicle, without measurable systemic absorption. This addresses the biological root cause of hair follicle miniaturization while avoiding the systemic side effects associated with oral therapies, such as reduced libido or sexual dysfunction. It is the first topical androgen receptor inhibitor designed specifically for male pattern hair loss.”

Researchers analyzed data from 1,465 adults enrolled in SCALP 1 and SCALP 2, two randomized, double-blind, vehicle-controlled studies conducted in the United States and Europe, followed by an additional 6-month single-blind treatment period. One study demonstrated a 539% relative improvement in target area hair count (TAHC) compared with vehicle; the second study showed a 168% relative improvement, according to the release.

Researchers assessed patient-reported outcomes using the MAA-PRO, a validated instrument capturing men’s self-assessment of hair growth and satisfaction, according to Hordinsky.

“In the phase 3 trials, one PRO endpoint reached statistical significance in one study, while the other study showed a positive trend,” Hordinsky said. “When data from both studies were analyzed together, the results were statistically significant and consistent with the objective TAHC measures, indicating that patients both noticed and valued the improvement in hair growth.”

Hordinsky said the 6-month phase 3 data are encouraging.

“Clascoterone 5% topical solution demonstrated meaningful improvements in TAHC and patient-reported outcomes, confirming that men both experienced and perceived improvement in hair growth,” Hordinsky told Healio. “Importantly, the treatment showed an excellent safety profile. Treatment emergent adverse events were similar to vehicle, most were mild and unrelated to the study drug, and no sexual side effects were reported. For men who are concerned about systemic hormonal effects, clascoterone 5% topical solution will provide a topical option that addresses hair loss safely and effectively.”

The topline data support potential submission of a new drug application to the FDA for clascoterone 5%, pending 12-month safety data, Diana Harbort, president of Cosmo’s dermatology division, told Healio. Those trials are ongoing; data are expected during the first half of 2026.

“Upon completion of the full dataset, the company plans to pursue parallel regulatory submissions in the U.S. and Europe,” Harbort told Healio. “If approved, clascoterone 5% topical solution could represent the first truly novel topical treatment for male pattern hair loss in over 30 years.”

For more information:

Diana Harbort can be reached at [email protected]. Maria Hordinsky, MD, can be reached at [email protected].

Sources/Disclosures

Source:

Press Release

Disclosures:
Harbort is president of the Cosmo Dermatology Division. Hordinsky reports receiving advisory board fees, grants, research support or serving as a study investigator for AbbVie, the American Hair Research Society, Baylor University, Casseopea, Columbia University, the National Alopecia Areata Foundation, Pfizer, the Scarring Alopecia Foundation, Sun Pharmaceuticals, and Veradermics and serves as an editor for McGraw Hill and UpToDate.

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