The brief
- Rezdiffra is the first FDA-approved MASH therapy (accelerated approval March 2024).
- Q2 2026 sales: $364.3M (+71% YoY); trailing-12-month revenue ~$1.3B.
- EMA conditional approval 2026; German launch Q4 2025; Europe rollout ongoing.
Technical approach
Mechanism
Liver-directed THR-β agonist
Rezdiffra activates thyroid hormone receptor beta in liver, improving lipid metabolism.
Target disease
Advanced fatty liver disease
MASH affects 18–25% of adults with high fibrosis progression risk.
Development
Accelerated approval pathway
FDA approval based on 52-week MAESTRO-NASH Phase 3 showing MASH resolution improvement.
Clinical benefit
First approved MASH therapy
No prior pharmacological treatments existed for MASH before Rezdiffra.
