Cosmo announced positive topline Phase 3 results from two trials (1,465 patients, US and Europe) in December 2025; company plans an FDA NDA filing in early 2027 and an EU MAA filing.
- Lab
- Phase 1
- Phase 2
- Phase 3
- Approved
Phase 3
How it works
Topical anti-androgen (same active ingredient as acne drug Winlevi) that blocks androgen receptors in the scalp to reduce DHT-driven follicle miniaturization.
Results so far
One trial: 539% relative improvement in target-area hair count vs vehicle; second trial: 168% relative improvement; pooled analysis >252% improvement (p<0.05). Treatment-emergent adverse events: 5.1% clascoterone vs 6.1% placebo. Patient-reported outcomes significant in one trial, a positive trend in the other.
What's next
NDA filing planned for early 2027; given typical FDA review timelines, approval (if any) unlikely before 2028.
In India
No India-specific trial or filing identified. Company statements say this could be the first new AGA mechanism in >30 years if approved in US/EU.
Sources
- News report ↗ (accessed 2026-10-17)
- News report ↗ (accessed 2026-10-17)
- Company announcement ↗ (accessed 2026-10-17)
What to do today: treatments in development aren't a reason to wait. Ask a dermatologist about the options that work now, such as minoxidil and, for men, finasteride.
Discussion
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