MASH and NASH

What is MASH and NASH?

Causes and Symptoms

Metabolic dysfunction–associated steatohepatitis (MASH) is a condition in which metabolic dysfunction leads to fat accumulation in the liver and subsequent inflammation (hepatitis). The disease was previously referred to as nonalcoholic steatohepatitis (NASH). Obesity and metabolic syndrome associated with an unhealthy diet and physical inactivity are major contributors to MASH. While alcohol consumption is a well-known cause of alcohol-associated fatty liver and liver injury, cases of fatty liver are increasing even among individuals who do not drink alcohol.

Treatment

First-line management focuses on lifestyle modification. Specifically, maintain nutritional balance by eating three regular meals per day and keeping total caloric intake within an appropriate range. Approximately 150 minutes of exercise per week is recommended—for example, 30 minutes of walking, five times per week. Adding resistance training can further increase metabolic rate.

As of 2025, no universally established, disease-specific pharmacotherapy that directly treats MASH has been confirmed. The fundamental approach remains reviewing and improving lifestyle habits in consultation with a specialist.

MASH and NASH Treatment Market

MASH and NASH Treatment Market is expected to grow

The MASH/NASH treatment market has expanded rapidly in recent years. It is projected to grow at a compound annual growth rate (CAGR) of 29.8% to US$7.38 billion by 2029. In addition, the overall MASH treatment market could exceed US$9.5 billion by 2030.

The possible reasons behind this rapid growth are,Increasing number of patients with metabolic diseases such as obesity and diabetes and early interventionIn addition to,Expansion of regular insurance coverage, increased awareness of liver disease, etc.can be considered.

New drugs accelerate market growth

In March 2024, the U.S. Food and Drug Administration (FDA) approved Rezdiffra, a thyroid hormone receptor-beta agonist. The European Commission (EC) subsequently announced on August 19, 2025 that conditional marketing authorization had been granted. The introduction of new therapies is accelerating market growth, and competition is expected to intensify.

CRO Selection Considerations

Given the anticipated expansion of the MASH/NASH treatment market, drug discovery organizations are conducting numerous studies and initiatives as they progress toward regulatory approval. In this environment, strategic selection of a contract research organization (CRO) is important.

This site introduces nonclinical contract research providers with technical capabilities, specialized expertise, and proven track records. These profiles may be useful when evaluating potential partners.

Nonclinical NASH study examples

GALT drug efficacy evaluation study

Galectin Therapeutics Inc. (NASDAQ: GALT) is conducting fibrosis-targeted drug efficacy studies using the STAM mouse model, which is widely used to evaluate therapies for NASH, fibrosis, and hepatocellular carcinoma (HCC). Separately, a Phase 2 clinical study in NASH cirrhosis is being conducted.

CANF drug evaluation study

Can-Fite BioPharma Ltd. (NYSE American: CANF) is also conducting drug evaluation studies in NASH. This work uses the STAM model, and a Phase 2 clinical study in NASH with liver fibrosis has been conducted since December 2021.

NEJM article

This article reports a Phase 3 study in adult patients with biopsy-confirmed NASH and fibrosis stage F1B, F2, or F3. It describes the methods and results of a study using resmetirom (a liver-directed, oral, selective thyroid hormone receptor-β agonist) being developed for the treatment of NASH.

Patients were randomized to one of three groups: resmetirom 80 mg once daily, resmetirom 100 mg once daily, or placebo. After 52 weeks, the endpoints included NASH resolution and fibrosis stage. The study concluded that both 80 mg and 100 mg resmetirom were superior to placebo for NASH resolution and for achieving at least a 1-stage improvement in fibrosis.