Resmetirom is under clinical development by Madrigal Pharmaceuticals and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Resmetirom’s likelihood of approval (LoA) and phase transition for Non Alcoholic Fatty Liver Disease (NAFLD) took place on 14 Nov 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

In addition, the same event on 14 Nov 2022 decreased Resmetirom’s LoA and PTSR for Non-Alcoholic Steatohepatitis (NASH).

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Resmetirom Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Resmetirom overview

Resmetirom (MGL-3196, VIA-3196, THR-Beta agonist 3196) is under development for the treatment of non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis. The therapeutic candidate is formulated as tablet and orally administered. The therapeutic candidate 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 biopharmaceutical company with focus 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 need. 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.

Quick View Resmetirom LOA Data

Report Segments
  • Innovator
Drug Name
  • Resmetirom
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • Metabolic Disorders
Key Developers
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.