Metabolic Dysfunction-Associated Steatohepatitis (MASH) Clinical Program Design
The shift from NAFLD/NASH to MASLD/MASH reflects a deeper understanding of hepatic conditions linked to metabolic disorders. Clinical trials for MASH are progressing rapidly, with FDA approvals and ongoing Phase 3 trials for drugs like resmetirom and pegozafermin.
Reference News
FDA granted accelerated approval to resmetirom (Rezdiffra) for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced fibrosis, supported by 18 clinical studies, including ongoing phase 3 MAESTRO-NASH trial.
The shift from NAFLD/NASH to MASLD/MASH reflects a deeper understanding of hepatic conditions linked to metabolic disorders. Clinical trials for MASH are progressing rapidly, with FDA approvals and ongoing Phase 3 trials for drugs like resmetirom and pegozafermin.