Cosmo Pharmaceuticals reported encouraging long-term results for its experimental male hair loss treatment. The treatment showed sustained hair growth and a strong safety profile after one year of clinical use.
The company said its topical drug, clascoterone, delivered continued hair regrowth in men with androgenetic alopecia, a common form of male pattern baldness. The findings come from an extension of late-stage trials conducted across the United States and Europe.
Earlier Phase 3
In earlier Phase 3 studies, clascoterone already demonstrated significant hair growth over six months in more than 1,400 male participants. The latest data shows that benefits continued when treatment extended to 12 months.
Key efficacy results
Cosmo reported that men who used clascoterone for a full year showed greater improvement in hair count. Their hair count increased 2.39 times more than men who stopped treatment after six months. This suggests continuous use plays a key role in maintaining results.
Participants who discontinued treatment after six months experienced a decline in hair count over time. In contrast, those who continued therapy maintained and improved hair density throughout the study period.
The company also highlighted a strong safety profile over the 12-month period. Researchers found that side effects remained comparable to placebo, with no significant hormone-related adverse effects observed.
How clascoterone works
Clascoterone is a topical androgen receptor inhibitor that blocks male scalp hormones, preventing follicle shrinkage and hair loss. This mechanism directly targets a key biological driver of androgenetic alopecia.
The company stated that the drug is designed for long-term use, reflecting the chronic nature of male pattern baldness. The company emphasised that sustained treatment may be necessary to maintain hair regrowth benefits.
The study included 1,465 men across multiple clinical sites in the US and Europe. It followed a randomised design to evaluate both efficacy and long-term safety outcomes. The results strengthen earlier findings from Phase 3 trials that showed statistically significant improvements in hair density over six months. The extension study now adds evidence for durability of response.
Cosmo noted that patient-reported outcomes aligned with clinical measurements. Participants reported improved satisfaction with hair appearance and treatment ease over the 12-month period.
Regulatory plans and commercial strategy
The company is preparing regulatory submissions based on the full dataset. It plans to file for US approval in early 2027, alongside applications in other major markets.
Cosmo is also exploring potential licensing partnerships to accelerate global development and commercialisation of the treatment. The company aims to expand access if regulatory approvals are granted.
Industry context and outlook
Experts cited in the study noted that the treatment represents a potentially new class of therapy for male pattern baldness. It may offer an alternative to existing options that require continuous use and have known side effects.
Hair loss affects a large global population, and demand for more effective long-term treatments continues to grow. The latest results add momentum to ongoing research in dermatological and regenerative therapies.