Sept. 13, 2023, Madrigal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for resmetirom for the treatment of adult patients with NASH with liver fibrosis. 
Nonalcoholic steatohepatitis (NASH) is a more advanced form of nonalcoholic fatty liver disease (NAFLD). 
Resmetirom is designed to target the underlying causes of NASH by reducing or eliminating liver fat (steatosis) as well as reducing liver inflammation, liver cell ballooning (hepatocyte cell death), and liver fibrosis that can lead to cirrhosis. Resmetirom is the only orally administered, small-molecule, liver-directed, truly β-selective THR agonist in Phase 3 development.