Metabolic Dysfunction-Associated Steatohepatitis Competitive Landscape

"DelveInsight’s, “Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Competitive Landscape and Clinical Trial Analysis, 2026,” report provides comprehensive insights about 180+ companies and 200+ drugs in Metabolic Dysfunction-Associated Steatohepatitis (MASH)  Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. 

 

Geography Covered

• Global coverage

 

Metabolic Dysfunction-Associated Steatohepatitis (MASH): Understanding

 

Metabolic Dysfunction-Associated Steatohepatitis (MASH): Overview

Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly nonalcoholic steatohepatitis (NASH), is the progressive inflammatory form of metabolic dysfunction-associated steatotic liver disease (MASLD). It is characterized by hepatic steatosis accompanied by hepatocellular injury, particularly hepatocellular ballooning, and lobular inflammation, with varying degrees of fibrosis. MASH occurs within the broader spectrum of MASLD and represents the stage at which metabolic disturbances and lipid accumulation are associated with significant hepatic inflammation and tissue injury.

The pathogenesis of MASH is complex and multifactorial. Research indicates that excessive hepatic lipid accumulation results from increased delivery of fatty acids to the liver, enhanced de novo lipogenesis, and impaired lipid oxidation and export. These disturbances contribute to lipotoxicity and cellular stress, which subsequently promote hepatocyte injury, inflammatory responses, and activation of fibrogenic pathways. Interactions among hepatocytes, immune cells, hepatic stellate cells, and signals from extrahepatic tissues further contribute to disease progression and fibrosis development.

MASH is strongly associated with cardiometabolic risk factors, particularly obesity, insulin resistance, Type 2 diabetes mellitus, and dyslipidemia. Disease progression is heterogeneous; while some individuals may remain stable or experience regression, others progress from MASH to increasing stages of fibrosis, cirrhosis, hepatic decompensation, and hepatocellular carcinoma. Among histological features, the stage of liver fibrosis is considered a major determinant of long-term clinical outcomes and mortality.

The increasing burden of metabolic disease has made MASH an important area of clinical and therapeutic research. Current research is focused on targeting the interconnected metabolic, inflammatory, and fibrogenic mechanisms underlying disease progression, while improving identification of patients with clinically significant fibrosis through non-invasive assessment approaches. Recent advances in the understanding of MASH biology and the development of disease-specific therapies have further transformed the management landscape, particularly for patients with non-cirrhotic MASH and moderate-to-advanced fibrosis.

 

Report Highlights

• 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.

• On May 27, 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), being held May 27–30 in Barcelona, Spain. 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, 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.

• In January 2026, Madrigal Pharmaceuticals announced an exclusive global license agreement with Pfizer for ervogastat, a clinical-stage oral DGAT-2 inhibitor, strengthening the company’s leadership in shaping the next generation of MASH therapies and combination regimens. DGAT-2 inhibitors work by blocking the final step in triglyceride assembly and storage, resulting in lower hepatic triglycerides, reduced lipotoxic fat and decreased inflammation in the liver.

 

Metabolic Dysfunction-Associated Steatohepatitis (MASH): Company and Product Profiles (Marketed Therapies)

 

1. Company Overview: Madrigal Pharmaceuticals, Inc.

Madrigal Pharmaceuticals, Inc. is a United States-based biopharmaceutical company focused on the development and commercialization of novel therapies for metabolic and liver diseases. The company has concentrated its research efforts on diseases with significant unmet medical needs, particularly metabolic dysfunction-associated steatohepatitis (MASH) and related liver conditions. Madrigal's lead product, Rezdiffra, represents a major advancement in the treatment landscape for MASH and became the first therapy approved in the United States specifically for patients with noncirrhotic MASH and moderate-to-advanced liver fibrosis.

 

Product Description: REZDIFFRA

Rezdiffra (resmetirom) is an orally administered, liver-directed thyroid hormone receptor beta (THR-β) agonist developed by Madrigal Pharmaceuticals. It selectively activates THR-β in the liver, helping reduce hepatic fat accumulation, inflammation, and fibrosis. The U.S. Food and Drug Administration approved Rezdiffra on March 14, 2024, for use in combination with diet and exercise for adults with noncirrhotic MASH/NASH and moderate-to-advanced liver fibrosis, consistent with fibrosis stages F2 to F3. Rezdiffra is administered orally once daily, with the recommended dose based primarily on patient body weight. It subsequently received authorization in the European Union and the United Kingdom for eligible adults with MASH and F2–F3 fibrosis.

 

2. Company Overview: Novo Nordisk A/S

Novo Nordisk A/S is a Denmark-based global healthcare company founded in 1923 and headquartered in Bagsværd, Denmark. The company specializes in the discovery, development, manufacturing, and commercialization of innovative therapies for serious chronic diseases, with a longstanding heritage and global leadership in diabetes care. Its current strategy is primarily focused on obesity, diabetes and related comorbidities, and rare diseases, supported by extensive expertise in protein and peptide science and incretin biology. Novo Nordisk markets its products in approximately 170 countries and employs approximately 68,800 people across 80 countries. The company continues to strengthen its metabolic disease portfolio through internal research, strategic partnerships, licensing agreements, and acquisitions, including investments in therapies for obesity-related comorbidities and MASH.

 

Product Description: WEGOVY

Wegovy (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist administered as a once-weekly subcutaneous injection. Semaglutide works by mimicking the activity of GLP-1, thereby regulating appetite, reducing caloric intake, improving metabolic parameters, and promoting weight loss. On August 15, 2025, the US Food and Drug Administration approved Wegovy for the treatment of adults with noncirrhotic MASH and moderate-to-advanced liver fibrosis, consistent with fibrosis stages F2 to F3. The approval was based on histological outcomes demonstrating improvements in MASH resolution and liver fibrosis in the ESSENCE clinical trial. Wegovy's MASH indication was granted under the FDA's accelerated approval pathway, with continued approval contingent on confirmation of clinical benefit in an ongoing long-term study.

 

3. Company Overview: Zydus Lifesciences Limited

Zydus Lifesciences Limited is an India-based global life sciences company engaged in the discovery, development, manufacturing, and commercialization of pharmaceutical products, biologics, vaccines, and novel therapies. The company has established research capabilities across multiple therapeutic areas, including cardio-metabolic diseases, inflammation and immunology, neuroscience, oncology, and rare diseases. Zydus has also developed innovative new chemical entities through its internal research programs, including saroglitazar, which became the first new chemical entity from an Indian research pipeline to progress from laboratory development to commercialization.

 

Product Description: LIPAGLYN/BILYPSA

Lipaglyn/Bilypsa (saroglitazar magnesium) is an orally administered dual peroxisome proliferator-activated receptor alpha/gamma (PPAR-α/γ) agonist developed by Zydus. It has predominant PPAR-α activity and targets metabolic abnormalities associated with dyslipidemia, insulin resistance, and liver disease. In India, saroglitazar received approval from the Drug Controller General of India for the treatment of noncirrhotic non-alcoholic steatohepatitis (NASH), now referred to as MASH, in March 2020, and Zydus subsequently received approval for its use in non-alcoholic fatty liver disease. The therapy is administered orally at a dose of 4 mg once daily. Saroglitazar is currently authorized for sale in India, while its use for MASH/NASH remains investigational in the United States.

 

Metabolic Dysfunction-Associated Steatohepatitis (MASH): Company and Product Profiles (Pipeline Therapies)

1. Company Overview: GSK plc

GSK plc is a United Kingdom-based global biopharmaceutical company focused on the discovery, development, and commercialization of specialty medicines, vaccines, and general medicines. Headquartered in London, the company operates in approximately 70 markets worldwide and reported EUR 32.7 billion in group turnover in 2025. GSK’s research and development strategy is centered on four core therapeutic areas—respiratory, immunology and inflammation; oncology; HIV; and infectious diseases—with its innovation efforts supported by advanced technologies and a broad pipeline of medicines and vaccines. In addition to its internal R&D activities, GSK actively expands its portfolio through targeted business development and acquisitions to strengthen its presence in areas of significant unmet medical need.

Product Description: Efimosfermin

Efimosfermin is an investigational, once-monthly fibroblast growth factor 21 (FGF21)-based therapy designed to address metabolic dysfunction and liver fibrosis in patients with MASH. The therapy has demonstrated improvements in liver fibrosis, MASH resolution, liver biomarkers, and cardiometabolic parameters in clinical studies. In April 2026, efimosfermin received Breakthrough Therapy Designation from the U.S. FDA and Priority Medicines (PRIME) designation from the European Medicines Agency for MASH. Following positive Phase II results, GSK advanced the candidate into its Phase III ZENITH clinical program for patients with MASH and moderate-to-advanced fibrosis.

 

2. Company Overview: Altimmune, Inc.

Altimmune, Inc. is a United States-based, late clinical-stage biopharmaceutical company incorporated in Delaware and headquartered in Gaithersburg, Maryland. The company is focused on developing novel therapies for serious liver diseases, with its development strategy centered on metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). Altimmune's lead and principal product candidate is an investigational peptide-based therapy acquired through the acquisition of Spitfire Pharma, Inc. in 2019, and the company is advancing its clinical development through late-stage and registrational programs. Altimmune is publicly traded on the Nasdaq Global Market under the ticker symbol ALT.

Product Description: Pemvidutide

Pemvidutide is an investigational, once-weekly, balanced 1:1 dual GLP-1/glucagon receptor agonist designed to address both metabolic dysfunction and liver disease in patients with MASH. Activation of the GLP-1 receptor contributes to weight loss and metabolic improvements, while glucagon receptor activity is intended to enhance energy expenditure and support reductions in hepatic fat. In the Phase IIb IMPACT trial, pemvidutide demonstrated improvements in MASH-related histological and non-invasive measures, including markers of fibrosis, liver stiffness, and cardiometabolic risk. The U.S. FDA has granted pemvidutide both Fast Track and Breakthrough Therapy Designation for MASH. Currently, the drug is in Phase III stage of its development for the treatment of MASH.

 

3. Company Overview: D&D Pharmatech

D&D Pharmatech is a clinical-stage biopharmaceutical company focused on developing revolutionary medicines for patients with metabolic, fibrotic, and neurodegenerative diseases. Its liver pipeline includes zabopegdutide and TLY012 for MASH and cirrhosis, with TLY012 demonstrating reversal of established fibrosis in multiple preclinical models, including liver cirrhosis, chronic pancreatitis, and systemic sclerosis. In neuroscience, pegsebrenatide (NLY01) and NLY02 target neuroinflammation and glial activation to slow neurodegeneration; pegsebrenatide has demonstrated clinical benefit in a Phase 2 Parkinson’s disease study, particularly in patients younger than 60, and is currently being evaluated in progressive multiple sclerosis.

Product Description: Zabopegdutide

Zabopegdutide (DD01) is an investigational, once-weekly subcutaneous dual glucagon-like peptide-1 (GLP-1) and glucagon receptor agonist being developed for MASH. The therapy has a differentiated GLP-1-to-glucagon potency profile designed to provide metabolic benefits while also directly targeting hepatic disease mechanisms. In a 48-week Phase II MASH trial, zabopegdutide demonstrated statistically significant improvements versus placebo across key histological endpoints, including MASH resolution without worsening of fibrosis and improvement in fibrosis without worsening of MASH.

 

4. Company Overview: Alnylam Pharmaceuticals/ Regeneron Pharmaceuticals

Alnylam Pharmaceuticals, Inc. is a United States-based biopharmaceutical company focused on the discovery, development, and commercialization of RNA interference (RNAi) therapeutics. The company has established a proprietary RNAi platform designed to selectively silence disease-associated genes and has developed a broad pipeline across rare, cardiovascular, metabolic, neurological, and other therapeutic areas.

Regeneron Pharmaceuticals, Inc. is a United States-based biotechnology company focused on the invention, development, and commercialization of medicines for serious diseases. The company has established a broad research and development portfolio spanning immunology and inflammation, oncology, cardiovascular and metabolic diseases, ophthalmology, hematology, infectious diseases, neurological disorders, and rare diseases.

Product Description: ALN-CIDEB

ALN-CIDEB is an investigational small interfering RNA (siRNA) therapeutic designed to target CIDEB (cell death-inducing DFFA-like effector B), a gene involved in hepatic lipid metabolism and lipid droplet biology. The therapy is intended to reduce CIDEB expression in the liver and thereby address hepatic lipid accumulation and underlying disease mechanisms associated with MASH. Development of ALN-CIDEB is led by Regeneron Pharmaceuticals under its collaboration with Alnylam. The candidate had completed Phase I clinical development, demonstrated encouraging safety and tolerability findings. Currently, the drug is in Phase II stage of its development for the treatment of MASH.

 

5. Company Overview: Changchun Intellicrown Pharmaceutical Co., Ltd.

Changchun Intellicrown Pharmaceutical Co., Ltd. is a China-based pharmaceutical company founded in 2013 and headquartered in Changchun, Jilin Province. The company is engaged in pharmaceutical research and development, manufacturing, commercialization, and related technology development and transfer activities, with capabilities spanning biopharmaceuticals and small-molecule drug development. Its research activities include programs in digestive and metabolic diseases as well as oncology, and the company has collaborated with research institutions, including the Institute of Materia Medica, Chinese Academy of Medical Sciences, on pharmaceutical innovation and drug development.

Product Description: IMM-H014

IMM-H014 is an investigational therapeutic candidate being developed for MASH and is currently in Phase I/II clinical development. The therapy acts as a stimulator of nuclear factor erythroid 2-related factor 1 (Nrf1) and nuclear factor erythroid 2-related factor 2 (Nrf2). These transcription factors play important roles in regulating cellular responses to metabolic stress, oxidative stress, and lipid homeostasis. Stimulation of the Nrf1/Nrf2 pathways is intended to enhance cellular antioxidant and protective responses, reduce oxidative stress, and improve hepatic metabolic homeostasis.

 

Company Overview: Tasly Biopharmaceuticals Co., Ltd.

Tasly Pharmaceutical Group Co., Ltd. is a China-based pharmaceutical company headquartered in Tianjin, with operations spanning the research, development, manufacturing, and commercialization of modern traditional Chinese medicines, chemical drugs, and biologics. Founded in 1994 and listed on the Shanghai Stock Exchange in 2002, the company focuses on therapeutic areas including cardiovascular and metabolic diseases, neurology and psychiatry, and digestive diseases. Its biopharmaceutical subsidiary, Tasly Biopharmaceuticals Co., Ltd., develops innovative biologics across metabolic, cardiovascular, oncology, and autoimmune diseases.

Product Description: B1344

B1344 is an investigational, long-acting site-specific PEGylated human FGF21 analog developed by Tasly for MASH and other metabolic diseases. The molecule was engineered to improve the biopharmaceutical properties of native FGF21, including extending its half-life and improving pharmacokinetic properties. B1344 selectively activates signaling through the βKlotho/FGFR1c receptor complex, a key pathway involved in the metabolic actions of FGF21. Activation of this pathway is intended to regulate glucose and lipid metabolism and improve metabolic homeostasis. B1344 is currently in Phase I clinical development. In its preclinical evaluation, subcutaneous administration of B1344 for 11 weeks in cynomolgus monkeys with NAFLD resulted in reductions in hepatic steatosis, inflammation, and fibrosis, together with improvements in liver injury and hepatocyte death.

Further product details are provided in the report……..

 

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Metabolic Dysfunction-Associated Steatohepatitis (MASH) Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition – deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

 

• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Report Assessment

• Company Analysis

• Therapeutic Assessment

• Pipeline Assessment

• Inactive drugs assessment

• Unmet Needs

 

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Clinical Trial Assessment

• Clinical Trial Analysis

• Clinical Trial Design Analysis

• Sponsor and Geographical Analysis

 

• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Clinical Trial Analysis

The report comprises of comparative assessment of clinical trial analysis (by status, development stage, therapy area, enrolled participants by age, study completion year, end point status).

• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Clinical Trial Design Analysis

The report comprises of comparative assessment of clinical trial design analysis (by allocation, interventional model, enrolled participants by status, masking).

• Sponsor and Geographical Analysis

The report comprises of comparative assessment of sponsor and geographical analysis (by top sponsors, developmental stage, clinical trials sponsored by countries, therapies by countries).

 

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Metabolic Dysfunction-Associated Steatohepatitis (MASH) drugs?

• How many Metabolic Dysfunction-Associated Steatohepatitis (MASH) drugs are developed by each company?

• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)?

• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Metabolic Dysfunction-Associated Steatohepatitis (MASH) therapeutics?

• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?

• What are the clinical studies going on for Metabolic Dysfunction-Associated Steatohepatitis (MASH) and their status?

• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• Zydus Cadila

• Novo Nordisk

• Madrigal Pharmaceuticals

• Cirius Therapeutics

• Inventiva Pharma

• Galmed Pharmaceuticals

• Galectin Therapeutics

• Viking Therapeutics

• Sagimet Biosciences

• Hepion Pharmaceuticals

• Boston Pharmaceuticals

• Boehringer Ingelheim

• Corcept Therapeutics

• Biostax Corp.

• AngioLab

• Oramed

• Can-Fite Biopharma

• MediciNova

• Metacrine

• Organovo Holdings

• Lipocine

• Chemomab Therapeutics

• NorthSea Therapeutics

• Rivus Pharmaceuticals

• 89bio Ltd.

• Merck Sharp & Dohme

• GSK

• HEC Pharma

• Enanta Pharmaceuticals

• CohBar

• SCOHIA PHARMA

• Tern Pharmaceuticals

• Tern Pharmaceuticals

• J2H Biotech

Key Products

• Saroglitazar magnesium

• Semaglutide

• Resmetirom

• MSDC-0602K

• Lanifibranor

• Aramchol

• Belapectin

• VK2809

• TVB-2640

• CRV431

• BOS-580

• BI 456906

• Miricorilant

• JKB-122

• ALS-L1023

• ORMD-0801

• Namodenoson

• MN-001

• MET642

• LPCN 1144

• CM101

• Icosabutate

• HU6

• BIO89-100

• Efinopegdutide

• ARO-HSD

• HEC88473

• EDP-297

• CB4211

• SCO-094

• TERN-201

• TERN-501

• J2H 1702