Metabolic Dysfunction-Associated Steatohepatitis Competitive Landscape And Clinical Trial Analysis Report 2026 Assesses 180+ Companies And 200+ Drugs
Dublin, Sept. 22, 2026 (GLOBE NEWSWIRE) -- "Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Competitive Landscape and Clinical Trial Analysis, 2026" has been added to ResearchAndMarkets.com's offering.
The "Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Competitive Landscape and Clinical Trial Analysis, 2026" report delivers a comprehensive global assessment of more than 180 companies and 200 marketed, clinical-stage and preclinical therapies. The report evaluates the MASH drug pipeline by development stage, product type, molecular class and route of administration while also examining inactive and discontinued programs.
Coverage includes company profiles, product assessments, clinical trial designs, development strategies, licensing agreements, collaborations, acquisitions and regulatory milestones. The analysis provides stakeholders with a detailed view of the rapidly evolving MASH treatment landscape and the scientific, clinical and commercial factors shaping future competition.
Global MASH Market and Disease Landscape
Metabolic dysfunction-associated steatohepatitis, formerly known as nonalcoholic steatohepatitis, is the progressive inflammatory form of metabolic dysfunction-associated steatotic liver disease. Its pathology includes hepatic steatosis, hepatocellular injury, lobular inflammation and varying degrees of fibrosis.
MASH pathogenesis involves hepatic lipid accumulation, de novo lipogenesis, impaired lipid oxidation, lipotoxicity, cellular stress, inflammatory signaling and activation of fibrogenic pathways. Interactions among hepatocytes, immune cells, hepatic stellate cells and extrahepatic tissues contribute to disease progression. MASH is strongly associated with obesity, insulin resistance, Type 2 diabetes and dyslipidemia, while fibrosis stage remains a major determinant of long-term clinical outcomes.
The expanding prevalence of metabolic disease continues to drive investment in therapies targeting metabolic, inflammatory and fibrotic mechanisms. Development programs are also incorporating non-invasive assessments to identify patients with clinically significant fibrosis and monitor treatment response.
Major MASH Industry Developments in 2026
- Altimmune initiated the global Phase III PERFORMA trial of pemvidutide in August 2026, with a 52-week data readout anticipated in 2029. D&D Pharmatech published 12-week Phase II DD01-DN-2 findings for zabopegdutide in July 2026 and reported positive 48-week histology results in May 2026. Novo Nordisk announced Indian regulatory approval of Wegovy for MASH in July 2026. Zealand Pharma reported positive Phase III results from Boehringer Ingelheim's survodutide program, including improvements in liver-related parameters and reductions in liver fat. MetaVia presented Phase I data for DA-1726 at EASL 2026, reporting favorable safety and tolerability alongside metabolic and exploratory liver-related findings. Madrigal Pharmaceuticals entered an exclusive global license agreement with Arrowhead Pharmaceuticals for ARO-PNPLA3 and secured rights to Pfizer's ervogastat, an oral DGAT-2 inhibitor. GSK's efimosfermin received FDA Breakthrough Therapy Designation and European Medicines Agency Priority Medicines designation following Phase II fibrosis data. Novo Nordisk completed its acquisition of Akero Therapeutics, adding the late-stage FGF21 analogue efruxifermin to its MASH portfolio. Altimmune received FDA Breakthrough Therapy Designation for pemvidutide based on evidence from the Phase IIb IMPACT trial. Suzhou Ribo Life Science and Ribocure Pharmaceuticals licensed six preclinical siRNA programs to Madrigal Pharmaceuticals.
Marketed MASH Therapies Covered in the Report
Rezdiffra - Madrigal Pharmaceuticals: Rezdiffra, or resmetirom, is an oral, liver-directed thyroid hormone receptor beta agonist. The FDA approved the therapy in March 2024 for adults with noncirrhotic MASH and moderate-to-advanced fibrosis in combination with diet and exercise. It subsequently received authorization in the European Union and the United Kingdom for eligible adults with F2-F3 fibrosis.
Wegovy - Novo Nordisk: Wegovy, or semaglutide, is a once-weekly GLP-1 receptor agonist. The FDA approved Wegovy in August 2025 for adults with noncirrhotic MASH and F2-F3 fibrosis under the accelerated approval pathway. The decision was supported by histological findings from the ESSENCE clinical trial, with continued approval subject to confirmation of clinical benefit.
Lipaglyn/Bilypsa - Zydus Lifesciences: Saroglitazar magnesium is an oral dual PPAR-alpha/gamma agonist with predominant PPAR-alpha activity. It is approved in India for noncirrhotic MASH and related metabolic liver indications. Its use in MASH remains investigational in the United States.
Selected MASH Pipeline Therapies
- Efimosfermin from GSK: A once-monthly investigational FGF21-based therapy in the Phase III ZENITH program for MASH with moderate-to-advanced fibrosis. Pemvidutide from Altimmune: A once-weekly dual GLP-1/glucagon receptor agonist in Phase III development following positive Phase IIb IMPACT findings. Zabopegdutide from D&D Pharmatech: A once-weekly dual GLP-1/glucagon receptor agonist that demonstrated statistically significant improvements across key Phase II histological endpoints. ALN-CIDEB from Alnylam Pharmaceuticals and Regeneron Pharmaceuticals: An investigational siRNA therapeutic targeting CIDEB that has progressed into Phase II development. IMM-H014 from Changchun Intellicrown Pharmaceutical: A Phase I/II candidate designed to stimulate Nrf1 and Nrf2 pathways associated with metabolic stress, oxidative stress and lipid homeostasis. B1344 from Tasly Biopharmaceuticals: A long-acting, site-specific PEGylated human FGF21 analogue in Phase I development for MASH and other metabolic diseases.
Competitive Intelligence and Clinical Trial Analysis
The MASH competitive landscape report compares companies by therapeutic approach, development stage and technology platform. Its commercial assessment examines company-to-company collaborations, industry-academic partnerships, licensing transactions, acquisitions and deal-value trends.
The clinical trial assessment evaluates studies by status, development phase, therapeutic category, participant age, enrollment, completion year and endpoint status. Trial design analysis covers allocation, interventional model, masking and participant status. Sponsor and geographic assessments compare leading trial sponsors, development stages, countries and regional therapy distribution.
The report also addresses company activity, therapeutic classes, active and inactive pipelines, unmet needs and emerging technologies. Key strategic questions include the number of companies developing MASH drugs, the distribution of assets by company and development stage, the status of ongoing clinical studies, recent regulatory designations and the role of mergers, acquisitions, partnerships and licensing agreements in portfolio expansion.
Companies and Products Featured
Prominent companies assessed include Madrigal Pharmaceuticals, Novo Nordisk, Zydus Lifesciences, GSK, Altimmune, D&D Pharmatech, Boehringer Ingelheim, Inventiva Pharma, Galmed Pharmaceuticals, Galectin Therapeutics, Viking Therapeutics, Sagimet Biosciences, Corcept Therapeutics, Can-Fite Biopharma, MediciNova, NorthSea Therapeutics, Rivus Pharmaceuticals, 89bio, Merck, Enanta Pharmaceuticals, Tern Pharmaceuticals and other global developers.
Selected products covered include resmetirom, semaglutide, saroglitazar magnesium, lanifibranor, aramchol, belapectin, VK2809, denifanstat, survodutide, miricorilant, namodenoson, icosabutate, HU6, pegozafermin, efinopegdutide, ARO-HSD, pemvidutide, efimosfermin, zabopegdutide, ALN-CIDEB, IMM-H014 and B1344.
The report provides decision-makers across biopharmaceutical companies, investment organizations, research institutions and healthcare strategy teams with an integrated analysis of the global MASH drug pipeline, clinical trial environment and competitive outlook for 2026 and beyond.
Key Topics Covered:
Introduction
Executive Summary
Metabolic Dysfunction-Associated Steatohepatitis (MASH): Overview
- Introduction Causes Pathophysiology Diagnosis Treatment
Metabolic Dysfunction-Associated Steatohepatitis (MASH) -Analytical Perspective: In-depth Commercial Assessment
- Metabolic Dysfunction-Associated Steatohepatitis (MASH) Collaboration Analysis by Companies
Competitive Landscape
- Comparative Assessment of Companies (by therapy, and development stage)
Metabolic Dysfunction-Associated Steatohepatitis (MASH): Company and Product Profiles (Marketed Therapies)
Madrigal Pharmaceuticals
- Company Overview
Rezdiffra
- Product Description Research and Development Activities Product Developmental Activities
Metabolic Dysfunction-Associated Steatohepatitis (MASH): Company and Product Profiles (Pipeline Therapies)
Late Stage Products (Phase III)
- Comparative Analysis
GSK
- Company Overview
Efimosfermin alfa
- Product Description Research and Development Activities Product Developmental Activities
Mid Stage Products (Phase II)
- Comparative Analysis
D and D Pharmatech
- Company Overview
Zabopegdutide
- Product Description Research and Development Activities Product Developmental Activities
Early Stage Products (Phase I)
- Comparative Analysis
Tasly Pharmaceutical Group
- Company Overview
B1344
- Product Description Research and Development Activities Product Developmental Activities
Preclinical Stage Products
- Comparative Analysis
Discovery Stage Products
- Comparative Analysis
Unknown Stage Products
- Comparative Analysis
Therapeutic Assessment
- Assessment by Product Type Assessment by Stage and Product Type Assessment by Route of Administration Assessment by Stage and Route of Administration Assessment by Molecule Type Assessment by Stage and Molecule Type
Clinical Trial Assessment
Clinical Trial Analysis
- Assessment by Status Assessment by Status and Phase of development Assessment by End Point Status Assessment by Enrolled Patients by Age Assessment by Study Completion Year
Clinical Trial Design Analysis
- Assessment by Allocation of Clinical Trials Assessment by Interventional Model of Clinical Trials Assessment by Enrolled Patients by Status Assessment by Masking of Clinical Trials
Sponsor and Geographical Analysis
- Assessment by Top Sponsors Assessment by Total Trials Sponsored by Countries and Phase Assessment by Clinical Therapies by Countries
Inactive Products
- Comparative Analysis
Metabolic Dysfunction-Associated Steatohepatitis (MASH)- Unmet needs
Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Market drivers and barriers
Appendix
List of Tables
Table 1 Total Products for Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Assessment by Status
Table 13 Assessment by Status and Phase
Table 14 Assessment by End Point Status
Table 15 Assessment of Enrolled Participants by Age
Table 16 Assessment by Study Completion Year
Table 17 Assessment by Primary Purpose of Clinical Trials
Table 18 Assessment by Allocation of Clinical Trials
Table 19 Assessment by Interventional Model of Clinical Trials
Table 20 Assessment by Masking of Clinical Trials
Table 21 Assessment by Enrolled participants by Status
Table 22 Assessment by Top Sponsors
Table 23 Assessment by Countries and Stage of Development
Table 24 Inactive Products
List of Figures
Figure 1 Total Products for Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Assessment by Status
Figure 13 Assessment by Status and Phase
Figure 14 Assessment by End Point Status
Figure 15 Assessment of Enrolled Participants by Age
Figure 16 Assessment by Study Completion Year
Figure 17 Assessment by Primary Purpose of Clinical Trials
Figure 18 Assessment by Allocation of Clinical Trials
Figure 19 Assessment by Interventional Model of Clinical Trials
Figure 20 Assessment by Masking of Clinical Trials
Figure 21 Assessment by Enrolled participants by Status
Figure 22 Assessment by Top Sponsors
Figure 23 Assessment by Countries and Stage of Development
Figure 24 Inactive Products
A selection of companies mentioned in this report includes, but is not limited to:
- 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
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