Cosmo Pharmaceuticals said on Wednesday that its experimental hair loss treatment demonstrated sustained hair growth and long-term safety in men with common pattern baldness after one year of use.
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The one-year extension study follows late-stage results reported in December, when the topical drug clascoterone met its primary endpoint in two large trials, showing significant hair growth in 1,465 men over a six-month period.
- Cosmo said on Wednesday that men who continued using clascoterone for 12 months experienced a statistically significant 2.39-fold improvement in hair count compared with those who stopped treatment after six months.
- The Ireland-based company reported that patients who discontinued the drug after six months showed a noticeable decline in hair count, while those who remained on clascoterone continued to see hair growth over the full 12-month period.
- Clascoterone is a topical treatment that works by blocking the effects of male hormones in the scalp, which are a key factor in hair follicle shrinkage and hair loss.
- The drug’s safety profile over 12 months was comparable to placebo, with no significant hormone-related side effects reported, according to Cosmo.
- Cosmo said it plans to seek U.S. regulatory approval in early 2027 and will submit full late-stage study data for presentation at scientific conferences.
- CEO Giovanni Di Napoli told Reuters that the company is also exploring licensing opportunities for the drug, aiming to partner with firms that can scale its reach globally to millions of men in the coming years.
- Other companies developing hair loss treatments include Pelage Pharmaceuticals, which is working on PP405, an experimental topical therapy designed to reactivate hair growth in both men and women.
