The first US Food and Drug Administration-approved medication to treat noncirrhotic non-alcoholic steatohepatitis, otherwise known as NASH, is Rezdiffra (resmetirom). NASH is an advanced form of non-alcoholic fatty liver disease (NAFLD), and it is caused by the accumulation of fat in the liver that is not due to consuming alcohol. Adults with NASH may exhibit fatigue and abdominal pain as the disease; it is a leading cause of liver-related mortality and drives the most liver transplants in the US. Rezdiffra contains a partial agonist for the THR-β and affects lipid metabolism. Activation of THR-β reduces intrahepatic triglycerides.

Produced by Madrigal Pharmaceuticals, the drug’s approval was based on the ongoing, distinct, non-invasive Phase III MAESTRO-NASH trial.

Reference: Rezdiffra for the Treatment of Noncirrhotic Non-alcoholic Steatohepatitis, US. Clinical Trials Arena. Published April 2, 2024. Accessed August 23, 2024. https://www.clinicaltrialsarena.com/projects/rezdiffra-treatment-nash-us/?cf-view