REZDIFFRA
REZDIFFRA (resmetirom) is a once-daily oral thyroid hormone receptor-beta (THR-β) agonist developed by Madrigal Pharmaceuticals and the first FDA-approved drug therapy for MASH — a progressive liver disease in which fat accumulation triggers inflammation and fibrosis. By selectively activating THR-β in liver cells, resmetirom increases fatty acid oxidation and reduces liver fat without the cardiovascular side effects associated with systemic thyroid hormone activation. Approved in March 2024 on biopsy endpoints in non-cirrhotic patients, Madrigal is now running a cardiovascular and liver outcomes trial to support a cirrhotic label expansion and stronger payer coverage.
Upcoming catalysts
Programs
MASH (NASH)
MASH is a progressive liver disease in which fat accumulation triggers inflammation and fibrosis; roughly 20% of patients progress to cirrhosis within 20 years and there was no approved drug until REZDIFFRA in March 2024. This program continues the commercial rollout in non-cirrhotic patients and runs a Phase 3 cardiovascular and liver outcomes trial — including cirrhotic patients — providing the hard endpoint data required for a cirrhotic label expansion and for payers who require outcomes beyond histological biopsy endpoints.