Cosmo unveils strong Phase III results for new male hair loss treatment
Cosmo Pharmaceuticals reported strong topline results from two Phase III trials of clascoterone 5% topical solution for male androgenetic alopecia, which the company calls the first major therapeutic advance in hair loss treatment in more than thirty years, Qazinform News Agency reports.
The studies, conducted in the United States and Europe, enrolled 1,465 patients and shared an identical design.
Both trials achieved statistically significant improvement in target area hair count. One study reported a 539% relative improvement compared to placebo, while the second recorded a 168% relative improvement. According to the company, safety and tolerability were comparable to the placebo vehicle, with most adverse events unrelated to the study drug.
Patient-reported outcomes supported the clinical findings. One study reached statistical significance and the other demonstrated a positive trend. A combined analysis confirmed that patients experienced and perceived meaningful regrowth.
Experts note that androgenetic alopecia affects up to two billion men worldwide and carries considerable emotional and social consequences. Clascoterone 5% solution is described as a new therapeutic approach. By blocking dihydrotestosterone directly at the hair follicle receptor without systemic absorption, it is designed to address the biological cause of male pattern hair loss without the risks linked to systemic medications.
“These data reflect a significant milestone for patients with male pattern hair loss,” said Dr. Maria Hordinsky of the University of Minnesota. “These findings show the potential for clascoterone 5% topical solution to deliver real, measurable regrowth with negligible systemic exposure.”
Cosmo CEO Giovanni Di Napoli stated that the results represent a pivotal moment for patients, noting that hair loss affects confidence and emotional well-being. “With strong efficacy and a favorable safety profile, clascoterone 5% topical solution opens the door to a better treatment paradigm,” he said.
Cosmo expects to finish the remaining safety follow up in spring 2026, after which the company plans to submit the treatment for approval in both the United States and Europe.
Earlier, Qazinform News Agency reported on a study by Ankara University indicating that domestic cats tend to meow or vocalize more actively when greeting male caregivers compared to female ones.
