An Ireland-based pharmaceutical company announced Wednesday that its investigational male baldness treatment demonstrated continued effectiveness and maintained safety standards during a full year of clinical testing.
Cosmo Pharmaceuticals revealed that their experimental medication, clascoterone, produced ongoing hair regrowth and proved safe for long-term use in men suffering from typical male pattern baldness throughout the 12-month study period.
This extended research builds upon promising late-stage trial results announced in December, where the topical medication successfully achieved its primary objectives in two comprehensive studies involving 1,465 men over a six-month timeframe, showing notable hair regrowth.
According to Cosmo’s Wednesday announcement, men who continued using clascoterone for the full 12-month period experienced a statistically significant improvement in hair count that was 2.39 times better than participants who discontinued treatment after the initial six months.
The company noted that participants who ceased treatment at the six-month mark saw a notable decrease in hair count, while those who remained on clascoterone experienced ongoing hair regrowth throughout the entire year-long study.
The medication works as a topical solution that prevents male hormones from affecting the scalp, targeting a primary factor behind hair follicle reduction and subsequent hair loss.
Cosmo reported that the drug maintained a safety profile similar to placebo treatments over the 12-month period, with no significant hormone-related adverse effects documented.
The company plans to seek U.S. regulatory approval in early 2027 and intends to present complete data from these advanced-stage studies at upcoming scientific conferences.
Cosmo CEO Giovanni Di Napoli shared with Reuters that the company is examining potential licensing partnerships for the medication. “We want to find a perfect partner that can scale this drug and can reach millions of men globally as quickly as possible. So that’s our goal and that’s what we’re going to do over the next few weeks and months,” he explained.
Other pharmaceutical companies are also working on innovative hair loss solutions, including Pelage Pharmaceuticals, which is developing PP405, an experimental topical treatment designed to restore hair growth in both men and women.
