Non-Alcoholic Steatohepatitis (NASH/MASH) - Drug Pipeline Insight 2026 75+ Candidates Across 70+ Companies Drive Licensing And Investment Opportunities
Dublin, Oct. 21, 2026 (GLOBE NEWSWIRE) -- "Non-Alcoholic Steatohepatitis (NASH) - Pipeline Insight, 2026" has been added to ResearchAndMarkets.com's offering.
The report delivers an in-depth analysis of the Non-Alcoholic Steatohepatitis (NASH) pipeline landscape, covering more than 70 companies and over 75 investigational therapies. It evaluates clinical and nonclinical candidates by development stage, product type, molecule type, and route of administration, while also examining discontinued and inactive programs.
The analysis provides commercial and clinical perspectives on emerging NASH therapies, including mechanisms of action, clinical studies, regulatory designations, product development activities, licensing agreements, collaborations, funding, mergers and acquisitions, and other strategic developments. It also assesses unmet needs, treatment trends, and technologies intended to address the limitations of current therapeutic approaches.
Non-Alcoholic Steatohepatitis Clinical Landscape
Non-Alcoholic Steatohepatitis is associated with hepatic steatosis, inflammation, hepatocyte injury, and progressive fibrosis. Fibrosis is a major predictor of liver-related outcomes and may advance to cirrhosis, portal hypertension, hepatic decompensation, or hepatocellular carcinoma. Clinical presentation is frequently asymptomatic or nonspecific, although fatigue and right upper quadrant discomfort may occur. Advanced disease can involve jaundice, ascites, sarcopenia, and complications associated with portal hypertension.
NASH pathogenesis involves insulin resistance, altered lipid metabolism, mitochondrial dysfunction, oxidative stress, inflammatory signaling, and fibrogenesis. Genetic susceptibility, metabolic dysregulation, and changes in the gut microbiome may also influence disease initiation and progression. Adipose tissue insulin resistance can increase the hepatic supply of free fatty acids, promote toxic lipid accumulation, and activate inflammatory pathways independently of diabetes or obesity status.
Liver biopsy remains an important method for assessing steatohepatitis and fibrosis, while non-invasive technologies continue to gain relevance. These include blood-based indices, ultrasonography, controlled attenuation parameter imaging, MRI-PDFF, and investigational serum biomarkers such as hyaluronic acid, YKL-40, TIMP-1, and PIIINP. The evolving diagnostic environment is supporting drug development, patient stratification, and clinical trial design across the NASH market.
Leading Non-Alcoholic Steatohepatitis Pipeline Drugs
- Efruxifermin - Novo Nordisk: Efruxifermin is an Fc-FGF21 fusion protein engineered to reproduce the biological activity profile of native FGF21. The candidate is intended to address liver fat, inflammation, fibrosis, insulin sensitivity, and lipid metabolism. It is being evaluated in Phase III development for NASH. HSK-31679 - Haisco Pharmaceutical Group Co., Ltd.: HSK-31679 is an orally active, liver-directed thyroid hormone receptor-beta agonist under Phase II evaluation. Preclinical findings indicate activity involving reductions in liver fat and inflammation, with potential effects on gut microbial sphingolipids and the hepatic inflammatory environment. VK2809 - Viking Therapeutics: VK2809 is an orally available small molecule thyroid hormone receptor agonist with liver tissue and beta receptor subtype selectivity. The candidate achieved primary and secondary endpoints in a Phase IIb study involving patients with biopsy-confirmed NASH and fibrosis. B1344 - Tasly Biopharmaceuticals Co., Ltd.: B1344 is a long-acting PEGylated FGF21 analog designed to activate signaling through the?Klotho/FGFR1c receptor complex. Preclinical studies reported reductions in hepatic steatosis, inflammation, fibrosis, liver injury, and hepatocyte death. The program is in Phase I development. ACT500 - Xiamen Amoytop Biotech Co., Ltd.: ACT500, formerly NM6606, is an investigational candidate in Phase I development. Early-stage clinical studies are evaluating its safety, tolerability, and pharmacokinetic profile in metabolic liver disease.
Pipeline Segmentation and Therapeutic Assessment
The report categorizes NASH pipeline products across late-stage Phase III, mid-stage Phase II, early-stage Phase I, pre-clinical, discovery, discontinued, and inactive programs. Routes of administration include oral, intravenous, subcutaneous, parenteral, and topical delivery. Molecule types include recombinant fusion proteins, small molecules, monoclonal antibodies, peptides, polymers, and gene therapies. Products are also assessed as monotherapies, combination therapies, or candidates with potential use in both settings.
Drug profiles examine pharmacological activity, clinical trial status, regulatory progress, and development strategies. The analysis also reviews Industry-Industry and Industry-Academia collaborations, licensing transactions, acquisitions, mergers, and funding initiatives shaping the Non-Alcoholic Steatohepatitis treatment pipeline.
Companies and Products Shaping the NASH Market
Prominent companies covered include Novo Nordisk, Haisco Pharmaceutical Group Co., Ltd., Viking Therapeutics, Tasly Biopharmaceuticals Co., Ltd., Xiamen Amoytop Biotech Co., Ltd., Sunshine Lake Pharma Co., Ltd, Corcept Therapeutics, J2H Biotech, GlaxoSmithKline, Hinova Pharmaceuticals Inc., Rivus Pharmaceuticals, Inc., Sinew Pharma Inc., Guangdong Raynovent Biotech Co., Ltd, Aligos Therapeutics, Inventiva Pharma, HighTide Biopharma Pty Ltd, MediciNova, Hudson Biotech, OrsoBio, Inc, 89bio, Inc., Inipharm Australia Pty Ltd, Changchun Intellicrown Pharmaceutical Co. LTD, Sino Biopharmaceutical Limited, and NorthSea Therapeutics B.V.
Additional pipeline assets include HEC-169584, Miricorilant, J2H-1702, GSK4532990, HP515, HU6, SNP-610, ZSP1601, ALG-055009, Lanifibranor, HTD-1801, MN-001, Tesamorelin, TLC-2716, Pegozafermin, INI-822, IMM-H014, TQA-2225, and Icosabutate.
Strategic Value of the Report
The report supports stakeholders seeking to understand the competitive NASH drug development environment, identify emerging therapeutic mechanisms, evaluate clinical-stage opportunities, and monitor inactive assets. It addresses the number of companies and drugs in development, the distribution of candidates across clinical phases, current trial activity, regulatory designations, partnership trends, and technologies designed to improve outcomes for patients with NASH and progressive liver fibrosis.
Key Topics Covered
Non-Alcoholic Steatohepatitis (NASH): Overview
- Introduction Signs and Symptoms Causes Pathophysiology Diagnosis Disease Management
Pipeline Therapeutics
- 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
Non-Alcoholic Steatohepatitis (NASH)- Analytical Perspective
Late Stage Products (Phase III)
- Comparative Analysis
Efruxifermin: Novo Nordisk
- Product Description Research and Development Product Development Activities
Mid Stage Products (Phase II)
- Comparative Analysis
VK2809: Viking Therapeutics
- Product Description Research and Development Product Development Activities
Early Stage Products (Phase I)
- Comparative Analysis
B1344: Tasly Biopharmaceuticals Co., Ltd.
- Product Description Research and Development Product Development Activities
Preclinical and Discovery Stage Products
- Comparative Analysis
Inactive Products
- Comparative Analysis
Non-Alcoholic Steatohepatitis (NASH) Key Companies
Non-Alcoholic Steatohepatitis (NASH) Key Products
Non-Alcoholic Steatohepatitis (NASH)- Unmet Needs
Non-Alcoholic Steatohepatitis (NASH)- Market Drivers and Barriers
Non-Alcoholic Steatohepatitis (NASH)- Future Perspectives and Conclusion
Non-Alcoholic Steatohepatitis (NASH) Analyst Views
Appendix
List of Tables [12]
List of Figures [12]
A selection of companies mentioned in this report includes, but is not limited to:
- Novo Nordisk Haisco Pharmaceutical Group Co., Ltd. Viking Therapeutics Tasly Biopharmaceuticals Co., Ltd. Xiamen Amoytop Biotech Co., Ltd. Sunshine Lake Pharma Co., Ltd Corcept Therapeutics J2H Biotech GlaxoSmithKline Hinova Pharmaceuticals Inc. Rivus Pharmaceuticals, Inc. Viking Therapeutics, Inc. Sinew Pharma Inc. Guangdong Raynovent Biotech Co., Ltd Aligos Therapeutics Inventiva Pharma HighTide Biopharma Pty Ltd MediciNova Hudson Biotech OrsoBio, Inc 89bio, Inc. Inipharm Australia Pty Ltd Changchun Intellicrown Pharmaceutical Co. LTD Sino Biopharmaceutical Limited NorthSea Therapeutics B.V.
For more information about this clinical trials report visit
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