Resmetirom for NASH: balancing promise and prudence

Drug development for non-alcoholic steatohepatitis (NASH; also known as metabolic dysfunction-associated steatohepatitis, MASH) with fibrosis has been a far from straightforward endeavour. Obeticholic acid, an agonist of the farnesoid X receptor and the first drug to have supportive phase 3 histological data for fibrotic NASH, was refused FDA approval on the basis of modest treatment efficacy and safety issues, including drug-induced liver injury. Selonsertib (an inhibitor of apoptosis signal-regulating kinase 1), elafibranor (a PPAR α/δ agonist), and cenicriviroc (a chemokine receptor type 2 and 5 antagonist) all failed to show benefit in phase 3 trials.