MASH in 2025: New Therapies, New Challenges
After years of clinical trial failures, metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH, is finally seeing breakthroughs in treatment approvals. The 2024–2025 period has been transformational : REZDIFFRA (resmetirom) and WEGOVY (semaglutide) have received conditional regulatory approvals in the U.S. (both drugs) and Europe (REZDIFFRA only), supported by a promising late-stage pipeline that includes: The expected approval of the GIP/GLP1 dual agonist tirzepatide (OZEMPIC) late 2025-early 2026 Additional drugs with new mechanisms of action Indication expansions to earlier and later stages of the disease These developments mark a step forward for patients who up to this moment have had no therapeutic options other than lifestyle adjustments. Given the high level of unmet need and large addressable population, MASH has been seen as an attractive therapeutic area for pharmaceutical developers. However, the approval of WEGOVY has disrupted the outlo...
