Metabolic Dysfunction-Associated Steatohepatitis Clinical Trial and Competitive Landscape Expands as 180+ Companies Target New Treatment Options | DelveInsight

The metabolic dysfunction-associated steatohepatitis competitive landscape report delivers important insights into approved as well as ongoing research on 200+ pipeline MASH drugs, clinical strategies, upcoming therapeutics, and commercial analysis.

New York, USA, Oct. 20, 2026 (GLOBE NEWSWIRE) -- Metabolic Dysfunction-Associated Steatohepatitis Clinical Trial and Competitive Landscape Expands as 180+ Companies Target New Treatment Options | DelveInsight

The metabolic dysfunction-associated steatohepatitis competitive landscape report delivers important insights into approved as well as ongoing research on 200+ pipeline MASH drugs, clinical strategies, upcoming therapeutics, and commercial analysis.

DelveInsight’s Metabolic Dysfunction-Associated Steatohepatitis Competitive Landscape and Clinical Trial Analysis 2026 report provides comprehensive global coverage of approved and pipeline MASH therapies across various stages of clinical development. The report offers an in-depth analysis of key trends, emerging therapies, and competitive landscape dynamics, highlighting the strategies of major pharmaceutical companies to advance the pipeline and capitalize on future growth opportunities. In addition, it includes critical insights into clinical trial benchmarking, partnering and licensing activities, and regulatory pathways involving the FDA and EMA, enabling stakeholders to make informed decisions and optimize development strategies within the MASH therapeutics domain.

Key Takeaways from the MASH Competitive Landscape Report

• DelveInsight’s MASH competitive landscape and clinical trial analysis report presents a robust market with over 180 active players developing more than 200 pipeline MASH therapies. 
• Key MASH companies, such as Zydus Cadila, Novo Nordisk, Madrigal Pharmaceuticals, Cirius Therapeutics, Inventiva Pharma, Galmed Pharmaceuticals, Galectin Therapeutics, Viking Therapeutics, Sagimet Biosciences, Boston Pharmaceuticals, Boehringer Ingelheim, Corcept Therapeutics, MediciNova, NorthSea Therapeutics, Rivus Pharmaceuticals, 89bio Ltd., Merck Sharp & Dohme, GSK, Xiamen Amoytop Biotech Co., Ltd., Eccogene, United Bio-Technology (Hengqin) Co., Ltd., Kriya Therapeutics, Inc., Sinew Pharma Inc., Shanghai Minwei Biotechnology, MAX Biopharma, Diapin Therapeutics, Inc., Tangram Therapeutics, MetaVia, and others, are evaluating new MASH drugs to improve the treatment landscape.
• Promising pipeline MASH therapies, such as MSDC-0602K, Lanifibranor, Aramchol, Belapectin, VK2809, TVB-2640, BOS-580, BI 456906, Miricorilant, MN-001, Icosabutate, HU6, BIO89-100, Efinopegdutide, ARO-HSD, ACT500, ECC4703, UBT251, VV-14303, SNP-610, MWN 109, Oxy210, DT109, TGM-312, DA-1726 and others, are under different phases of MASH clinical trials.
• Approximately 5+ MASH medications are in the late stage of development, whereas 100+ drugs are in the mid and early stages of development.
• Key MoAs under development include Fibroblast growth factor 21 replacements, Glucagon receptor agonists, Glucagon-like peptide-1 receptor agonists, CIDEB protein expression inhibitors, RNA interference, NF-E2 related factor agonists, and others.

Request a sample and discover the recent developments in MASH treatment @ https://www.delveinsight.com/report-store/metabolic-dysfunction-associated-steatohepatitis-competitive-landscape-and-clinical-trial-analysis

What is Metabolic Dysfunction-Associated Steatohepatitis?

Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), is a progressive form of metabolic dysfunction-associated steatotic liver disease (MASLD) characterized by the accumulation of excess fat in the liver accompanied by inflammation and hepatocellular injury. It is commonly associated with metabolic risk factors such as obesity, type 2 diabetes, insulin resistance, dyslipidemia, and hypertension. Unlike simple hepatic steatosis, MASH can progressively cause liver fibrosis and, in advanced cases, lead to cirrhosis, liver failure, and hepatocellular carcinoma. Because the disease is often asymptomatic in its early stages, diagnosis typically involves a combination of clinical assessment, blood-based biomarkers, imaging techniques, and, in selected cases, liver biopsy. The growing prevalence of obesity and metabolic disorders worldwide has contributed to increasing disease burden and intensified efforts to develop effective pharmacological therapies targeting both metabolic dysfunction and liver inflammation/fibrosis. 

To know more about MASH, visit @ Metabolic Dysfunction-Associated Steatohepatitis Therapies 

Approved MASH Drug Profile Analysis

REZDIFFRA: Madrigal Pharmaceuticals, Inc.

REZDIFFRA (resmetirom) is an oral, liver-targeted thyroid hormone receptor beta (THR-β) agonist developed by Madrigal Pharmaceuticals. By selectively activating THR-β in the liver, the therapy is designed to reduce hepatic fat accumulation and address inflammation and fibrosis. On March 14, 2024, the U.S. Food and Drug Administration (FDA) approved REZDIFFRA in combination with diet and exercise for adults with noncirrhotic MASH/NASH and moderate-to-advanced liver fibrosis, corresponding to fibrosis stages F2–F3. The treatment is administered orally once daily, with the recommended dose determined primarily by the patient’s body weight. REZDIFFRA has also subsequently received authorization in the European Union and the United Kingdom for eligible adults with MASH and F2–F3 fibrosis.

LIPAGLYN/BILYPSA: Zydus Lifesciences Limited

LIPAGLYN/BILYPSA (saroglitazar magnesium) is an orally administered dual peroxisome proliferator-activated receptor alpha/gamma (PPAR-α/γ) agonist developed by Zydus. The drug exhibits predominant PPAR-α activity and is designed to address metabolic abnormalities associated with dyslipidemia, insulin resistance, and liver disease. In India, saroglitazar received approval from the Drug Controller General of India in March 2020 for the treatment of noncirrhotic non-alcoholic steatohepatitis (NASH), now termed metabolic dysfunction-associated steatohepatitis (MASH). Zydus subsequently secured approval for its use in non-alcoholic fatty liver disease (NAFLD). The therapy is administered orally at a dose of 4 mg once daily. Saroglitazar is currently approved for commercial use in India, whereas its application in MASH/NASH remains investigational in the United States.

Find out more about what's the best pharma company offering MASH medications @ Metabolic MASH Drug Pipeline

A snapshot of the Pipeline Metabolic Dysfunction-Associated Steatohepatitis Drugs mentioned in the report:

Drug Name	Company	Phase	MoA	RoA
Efimosfermin	GSK	III	Fibroblast growth factor 21 replacements	SC
Pemvidutide	Altimmune, Inc.	III	Glucagon receptor agonists; Glucagon-like peptide-1 receptor agonists	SC
Zabopegdutide	D&D Pharmatech	II	Glucagon receptor agonists; Glucagon-like peptide-1 receptor agonists	SC
ALN-CIDEB	Alnylam Pharmaceuticals/ Regeneron Pharmaceuticals	II	CIDEB protein expression inhibitors; RNA interference	SC
IMM-H014	Changchun Intellicrown Pharmaceutical Co., Ltd.	I/II	NF-E2 related factor agonist	Oral
B1344	Tasly Biopharmaceuticals Co., Ltd.	I	Fibroblast growth factor replacements	SC

Learn more about the emerging MASH therapies @ Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials

Arunima Dabral, Assistant Project Manager of Competitive Intelligence and Consulting at DelveInsight, said that MASH is a progressive liver disease closely linked to obesity, type 2 diabetes, and broader metabolic dysfunction, with potential to advance to cirrhosis and liver cancer. The market is shifting from lifestyle management to disease-modifying therapy, driven by rising cardiometabolic risk, improved diagnosis, and the arrival of resmetirom and semaglutide, while a growing pipeline of FGF21, incretin, and liver-targeted agents is intensifying competition and expanding treatment options.

Recent Developments in the Metabolic Dysfunction-Associated Steatohepatitis Treatment Space

• In September 2026, Tangram Therapeutics announced progression of its MASH investigational treatment TGM-312 into Part B of the ongoing Phase I/II RESTORE-MASH trial.
• In September 2026, Inventiva announced the last patient has completed their final 72-week visit in the NATiV3 Phase III clinical trial evaluating lanifibranor for the treatment of patients with MASH with moderate and advanced fibrosis.
• In August 2026, Altimmune announced the initiation of the global PERFORMA Phase III MASH trial, with 52-week data readout anticipated in 2029.
• In July 2026, D&D Pharmatech announced the publication of 12-week results from its Phase II DD01-DN-2 study evaluating zabopegdutide (DD01) in patients with MASLD/MASH in the Lancet Gastroenterology & Hepatology. 
• In July 2026, Novo Nordisk announced that India's drug regulator has approved its obesity drug Wegovy for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), a serious form of fatty liver disease.
• In June 2026, Zealand Pharma announced positive Phase III results reported by Boehringer Ingelheim for survodutide, a glucagon/GLP-1 dual agonist being developed under their partnership. The SYNCHRONIZE-MASLD study showed improvements in liver-related parameters, while additional data demonstrated up to a 63.1% reduction in liver fat, further supporting the therapeutic potential of survodutide across metabolic liver disease. 
• In May 2026, MetaVia announced the presentation of new Phase I data on DA-1726, a novel dual oxyntomodulin (OXM) analog agonist targeting glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR), in a late-breaking poster presentation at the European Association for the Study of the Liver Congress 2026 (EASL 2026). The data highlighted favorable safety and tolerability, clinically meaningful reductions in body weight and waist circumference at the 48 mg dose without titration, and exploratory, noninvasive liver-related findings supporting continued evaluation in metabolic dysfunction-associated steatohepatitis.
• In May 2026, Altimmune announced plans to initiate the global PERFORMA Phase III registrational trial of pemvidutide in the second half of 2026. The company stated that the study protocol had been finalized and submitted to the FDA, with the trial design aligned with feedback from both the FDA and EMA. The company also reported a strengthened financial position following recent financing, with USD 535 million in cash, cash equivalents, and short-term investments as of April 30, 2026. The company indicated that the financing would support continued execution of its pemvidutide development program, including the planned Phase III MASH trial. 
• In May 2026, Madrigal Pharmaceuticals announced an exclusive global license agreement with Arrowhead Pharmaceuticals for ARO-PNPLA3, a clinical-stage, small interfering RNA (siRNA) asset targeting patatin-like phospholipase domain-containing protein 3 (PNPLA3), a key genetic driver of MASH.
• In May 2026, D&D Pharmatech announced positive top-line 48-week histology results from its Phase II trial (DD01-DN-02) evaluating zabopegdutide (DD01) in patients with Metabolic Dysfunction-Associated Steatohepatitis. 
• In April 2026, Rivus Pharmaceuticals Inc. reported first patients dosed in the AMPLIFY Phase II clinical trial for HU6, a potential best-in-class oral MASH therapy.
• In April 2026, GSK announced that efimosfermin received FDA Breakthrough Therapy Designation and EMA Priority Medicines (PRIME) designation for MASH. The regulatory designations were based on Phase II data demonstrating improvement in liver fibrosis and are intended to support the accelerated development of the company's once-monthly investigational therapy. 
• In February 2026, Novo Nordisk highlighted the completion of its acquisition of Akero Therapeutics, including efruxifermin, a late-stage FGF21 analogue being developed for MASH. The acquisition expanded Novo Nordisk's MASH pipeline, including efruxifermin's development in patients with fibrosis and compensated cirrhosis. 
• In February 2026, Suzhou Ribo Life Science Co., Ltd. and its subsidiary Ribocure Pharmaceuticals AB announced that they have entered into an exclusive worldwide licensing agreement with Madrigal Pharmaceuticals, Inc. for six pre-clinical small interfering RNA (siRNA) programs for the treatment of metabolic dysfunction-associated steatohepatitis.
• In January 2026, Altimmune announced that the FDA had granted Breakthrough Therapy Designation to pemvidutide for the treatment of MASH. The designation followed clinical evidence from the company's Phase IIb IMPACT trial and provided an important regulatory milestone ahead of the planned Phase III registrational program.

Scope of the Metabolic Dysfunction-Associated Steatohepatitis Pipeline Report 

• Coverage: Global 
• Key Metabolic Dysfunction-Associated Steatohepatitis Companies: Zydus Cadila, Novo Nordisk, Madrigal Pharmaceuticals, Cirius Therapeutics, Inventiva Pharma, Galmed Pharmaceuticals, Galectin Therapeutics, Viking Therapeutics, Sagimet Biosciences, Boston Pharmaceuticals, Boehringer Ingelheim, Corcept Therapeutics, MediciNova, NorthSea Therapeutics, Rivus Pharmaceuticals, 89bio Ltd., Merck Sharp & Dohme, GSK, Xiamen Amoytop Biotech Co., Ltd., Eccogene, United Bio-Technology (Hengqin) Co., Ltd., Kriya Therapeutics, Inc., Sinew Pharma Inc., Shanghai Minwei Biotechnology, MAX Biopharma, Diapin Therapeutics, Inc., Tangram Therapeutics, MetaVia and others.
• Key Pipeline Metabolic Dysfunction-Associated Steatohepatitis Therapies: MSDC-0602K, Lanifibranor, Aramchol, Belapectin, VK2809, TVB-2640, BOS-580, BI 456906, Miricorilant, MN-001, Icosabutate, HU6, BIO89-100, Efinopegdutide, ARO-HSD, ACT500, ECC4703, UBT251, VV-14303, SNP-610, MWN 109, Oxy210, DT109, TGM-312, DA-1726 and others.

Frequently Asked Questions from the MASH Competitive Landscape and Clinical Trial Analysis

• How is AI transforming the MASH clinical trial landscape, competitive intelligence, and drug development strategies?
• Which pharmaceutical companies and investigational therapies are leading the race to develop next-generation treatments for metabolic dysfunction-associated steatohepatitis (MASH)?
• How do competing MASH therapies compare in clinical efficacy, safety, tolerability, and their ability to improve liver fibrosis and resolve steatohepatitis?
• Which emerging mechanisms of action, including FGF21 analogs, GLP-1 receptor agonists, dual glucagon/GLP-1 agonists, and RNA interference, could reshape the future of MASH treatment?
• How can AI identify emerging clinical trial trends, competitor milestones, regulatory developments, and potential market disruptions in the MASH therapeutics landscape?
• Where are the biggest unmet medical needs and opportunities for differentiation in the MASH treatment market, particularly among patients with advanced liver fibrosis and cirrhosis?
• How can AI-driven insights help pharmaceutical leaders make smarter clinical development, investment, licensing, and strategic partnering decisions in the evolving MASH market?
• Which late-stage MASH pipeline candidates are most likely to influence the competitive landscape, and what key clinical and regulatory milestones should stakeholders monitor?
• How are recent approvals of MASH therapies, including REZDIFFRA and other emerging treatment options, influencing competition and the adoption of disease-modifying therapies?
• How can clinical trial benchmarking help compare competing MASH drug candidates based on trial design, endpoints, patient populations, efficacy outcomes, and development timelines?
• Which pharmaceutical companies are actively pursuing licensing agreements, acquisitions, and strategic collaborations to strengthen their MASH drug pipelines?
• How could combination therapies targeting metabolic dysfunction, liver inflammation, and fibrosis transform treatment outcomes and reshape the future MASH market?
• What are the major clinical, regulatory, and commercial challenges facing companies developing innovative MASH therapies, and how can they address these barriers?
• How can AI-powered competitive intelligence help identify promising MASH pipeline assets, evaluate competitor strategies, and anticipate future market opportunities?

Dive deep into rich insights for new treatments for MASH, visit @ Metabolic Dysfunction-Associated Steatohepatitis Medications

Table of Contents

1.	Metabolic Dysfunction-Associated Steatohepatitis Pipeline Report Introduction
2.	Metabolic Dysfunction-Associated Steatohepatitis Pipeline Report Executive Summary
3.	Metabolic Dysfunction-Associated Steatohepatitis Pipeline: Overview
4.	Metabolic Dysfunction-Associated Steatohepatitis Marketed Drugs
4.1.	REZDIFFRA: Madrigal Pharmaceuticals
5.	Metabolic Dysfunction-Associated Steatohepatitis Clinical Trial Therapeutics
6.	Metabolic Dysfunction-Associated Steatohepatitis Pipeline: Late-Stage Products (Pre-registration)
7.	Metabolic Dysfunction-Associated Steatohepatitis Pipeline: Late-Stage Products (Phase III)
7.1.	Efimosfermin alfa: GSK
8.	Metabolic Dysfunction-Associated Steatohepatitis Pipeline: Mid-Stage Products (Phase II)
8.1.	Zabopegdutide: D and D Pharmatech
9.	Metabolic Dysfunction-Associated Steatohepatitis Pipeline: Early-Stage Products (Phase I)
9.1.	B1344: Tasly Pharmaceutical Group
10.	Metabolic Dysfunction-Associated Steatohepatitis Pipeline: Preclinical and Discovery Stage Products
11.	Metabolic Dysfunction-Associated Steatohepatitis Pipeline Therapeutics Assessment
12.	Inactive Products in the Metabolic Dysfunction-Associated Steatohepatitis Pipeline
13.	Company-University Collaborations (Licensing/Partnering) Analysis
14.	Unmet Needs
15.	Metabolic Dysfunction-Associated Steatohepatitis Market Drivers and Barriers
16.	Appendix

For further information on the MASH pipeline therapeutics, reach out @ Metabolic Dysfunction-Associated Steatohepatitis Therapeutics

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