Resmetirom is under clinical development by Madrigal Pharmaceuticals and currently in Phase III for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). According to GlobalData, Phase III drugs for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Resmetirom LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Resmetirom overview

Resmetirom (Rezdiffra) is a liver-directed therapy. It is formulated as film coated tablets for oral route of administration. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). 

Resmetirom (MGL-3196, VIA-3196) is under development for the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis. The therapeutic candidate is formulated as tablet and is orally administered. It acts by targeting beta-selective thyroid hormone receptor.

It was also under development for the treatment of heterozygous and homozygous familial hypercholesterolemia (HeFH, HoFH).

Madrigal Pharmaceuticals overview

Madrigal Pharmaceuticals (Madrigal), formerly Synta Pharmaceuticals Corp, is a clinical-stage biopharmaceutical company that focuses on the development and commercialization of novel drugs for the treatment of liver, cardiovascular, and metabolic diseases. Its lead product candidate, resmetirom (MGL-3196), is a proprietary, liver-directed, selective thyroid hormone receptor beta (THR-beta) agonist that can potentially help treat several diseases with high unmet medical needs. The company is developing resmetirom for non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), associated dyslipidemias and familial hypercholesterolemia (FH). The company is also developing MGL-3745 (THR-beta agonist), a preclinical compound that has thyroid receptor selectivity similar to that of MGL-3196. Madrigal is headquartered in West Conshohocken, Pennsylvania, the US.

For a complete picture of Resmetirom’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.