Timeline · 6 min read
When will clascoterone (Breezula) be available?
Filing is not approval. Approval is not launch. Here is the calendar as of 30 August 2026.
Where it stands (30 August 2026)
- Phase 3 efficacy topline: December 2025
- 12-month safety / durability topline: April 2026
- Full journal publication: still awaited
- US NDA: company target early 2027
- EU MAA: in preparation, same broad window
- Approved for AGA anywhere: no
United States
A standard FDA review after NDA filing often runs 8–12 months if the file is clean, longer if the agency wants more data. An early-2027 filing implies a late-2027 to 2028 decision band, not a promise. Launch then depends on manufacturing, a commercial partner (Cosmo has discussed licensing), and payer negotiations.
Europe and UK
EMA review has its own clock. UK access after Brexit is a separate national step even when EMA moves. Do not plan a 2026 UK pharmacy date.
Price and access
Nobody has published a list price. Analogues: branded topical dermatology often lands well above generic minoxidil and in the same conversation as branded Winlevi acne cream. Cash-pay telehealth will try to package it. Insurers will stall on a new chronic cosmetic-adjacent drug.
Meanwhile, pattern hair loss does not pause. Use the years of waiting on therapies that already have labels: the 2026 stack.