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# Madrigal NDA for Nonalcoholic Steatohepatitis
- URL: https://www.fdaweb.com/madrigal-nda-for-nonalcoholic-steatohepatitis/
- Published: 2023-09-13T12:00:00.000Z
- Updated: 2026-09-14T18:56:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155321

FDA has accepted for priority review a Madrigal Pharmaceuticals NDA for resmetirom and its use in treating adult patients with nonalcoholic steatohepatitis (NASH). The agency has set a 3/14/2024 user fee review action date. The company is seeking accelerated approval.

Resmetirom is described as a once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver. The drug’s clinical development program comprises 18 clinical studies. “In the MAESTRO-NASH biopsy trial, resmetirom achieved both liver histological improvement endpoints proposed by FDA as reasonably likely to predict clinical benefit and demonstrated a well-tolerated safety profile,” the company says.

Madrigal says that MAESTRO-NASH enrolled patients (about 1,750) will continue on therapy for up to 54 months to measure hepatic clinical outcome events, including progression to cirrhosis on biopsy and hepatic decompensation events, as well as all-cause mortality. “This portion of the study is designed to generate confirmatory data that, if positive, may help verify resmetirom’s clinical benefit and support full approval,” it adds.