Related Experiment Video

Updated: Apr 13, 2026

Mouse Model of Metabolic Dysfunction-Associated Steatotic Liver Disease with Fibrosis
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Mouse Model of Metabolic Dysfunction-Associated Steatotic Liver Disease with Fibrosis

Published on: July 18, 2025

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MASH and liver fibrosis: Clinical trials to watch

Xinrong Zhang1, Vincent Wai-Sun Wong2

  • 1Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong, P.R. China.

Med (New York, N.Y.)
|April 12, 2026
PubMed

Insights

Metabolic dysfunction-associated steatohepatitis (MASH) treatments show promise, but drugs need full FDA approval for advanced liver disease. Current research focuses on unmet needs in MASH cirrhosis and identifying new therapeutic targets.

Area of Science:

  • Hepatology and gastroenterology
  • Pharmacology and drug development
  • Translational medicine

Background:

  • Metabolic dysfunction-associated steatohepatitis (MASH) is a significant driver of liver cirrhosis and hepatocellular carcinoma.
  • Existing treatments have shown histological improvements but lack data on major adverse liver outcomes.
  • There is a critical unmet medical need for approved therapies targeting MASH cirrhosis.

Purpose of the Study:

  • To provide an overview of the current drug development landscape for MASH.
  • To highlight promising therapeutic targets for MASH and its complications.
  • To inform clinicians and researchers about the status of MASH therapeutics.

Main Methods:

  • Review of recent clinical trial data for MASH therapeutics.
  • Analysis of conditional FDA approvals and requirements for full approval.
  • Identification and summary of emerging drug targets in MASH research.

Main Results:

  • Resmetirom and semaglutide have received conditional FDA approval based on histological data.
  • Full approval for these agents is pending demonstration of reduced major adverse liver outcomes.
  • No drugs are currently approved for MASH cirrhosis, indicating a significant therapeutic gap.

Conclusions:

  • The development of MASH therapeutics is advancing, with some agents nearing full approval.
  • Addressing MASH cirrhosis remains a key challenge and a focus for future drug development.
  • Continued research into novel therapeutic targets is essential for managing MASH progression.

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