Cosmo Pharma's male hair loss treatment shows sustained hair growth in year‑long study

Cosmo NV

15/04/2026 06:01

By Sneha S K and Sahil  Pandey

April 15 (Reuters) - Cosmo Pharmaceuticals COPN.S said on Wednesday its experimental hair loss treatment showed sustained hair growth and long-term safety in men with common pattern baldness after a year of use.

The year‑long extension study follows late-stage data reported in December, when the topical drug, called clascoterone, met its main goals in two large studies where it showed significant hair growth in 1,465 men over six months.

Cosmo on Wednesday said men who stayed on clascoterone for 12 months saw a statistically significant 2.39-times improvement in hair count compared to those who stopped the treatment after six months.

The Ireland-based company said patients who stopped treatment after six months experienced a meaningful decline in hair count compared to patients on clascoterone who saw continued hair growth throughout the 12 months.

Clascoterone is a topical solution that works by blocking the effects of male hormones in the scalp, which are a main cause of hair follicle shrinkage and hair loss.

The drug's safety profile over 12 months was comparable to placebo, with no meaningful hormone-related side effects reported, Cosmo said.

Cosmo said it plans to file for U.S. regulatory approval in early 2027 and aims to submit the full data from the late-stage studies for publication at scientific meetings.

Cosmo CEO Giovanni Di Napoli told Reuters the company is also exploring options to license the drug. "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 said.

Other companies developing novel treatments for hair loss include Pelage Pharmaceuticals, whose PP405 is an experimental topical therapy to restart hair growth in men and women.

 (Reporting by Sneha S K and Sahil Pandey in Bengaluru; Editing by Maju Samuel)

 ((Sahil.Pandey@thomsonreuters.com;))