Cosmo Pharmaceuticals said on Wednesday that clascoterone, its investigational topical treatment for male pattern hair loss, produced sustained increases in hair count and maintained a safety profile comparable to placebo over 12 months of use in men with common pattern baldness.
The year-long extension follows late-stage results disclosed in December, when clascoterone met primary endpoints in two large studies that together involved 1,465 men evaluated over six months. In the extension, Cosmo reported that men who remained on clascoterone for the full 12 months experienced a statistically significant 2.39-times improvement in hair count relative to men who stopped treatment after six months.
Cosmo said patients who discontinued therapy at six months showed a meaningful decline in hair count, while those who continued on clascoterone saw continued hair growth throughout the 12-month period.
Clascoterone is formulated as a topical solution designed to block the action of male hormones in the scalp - a principal driver of follicle miniaturization and hair loss. Over the 12-month observation window, the company said the drug's safety profile was similar to placebo and that no meaningful hormone-related side effects were reported.
The Ireland-based firm indicated it intends to file for U.S. regulatory approval in early 2027 and plans to submit the complete late-stage data for presentation at scientific meetings. Cosmo's chief executive, Giovanni Di Napoli, said the company is exploring licensing options and seeking a partner capable of scaling the product to reach large numbers of men globally as quickly as possible.
Cosmo also noted that other companies are pursuing novel approaches to hair-loss treatment; the company cited Pelage Pharmaceuticals and its experimental topical candidate, PP405, as an example of concurrent development activity in the field.
The company’s announcement provides additional evidence on durability of effect and tolerability for clascoterone in men with common pattern baldness, while outlining near-term regulatory and commercial steps the company intends to pursue.
Context and next steps
Cosmo will prepare a U.S. regulatory submission targeted for early 2027 and will aim to place the full dataset from its late-stage trials before the scientific community through meeting presentations. The company is actively seeking licensing partners to help scale the therapy if approved.