DelveInsight’s, “Nonalcoholic Steatohepatitis Pipeline Insight, 2025” report provides comprehensive insights about 80+ companies and 80+ pipeline drugs in Nonalcoholic Steatohepatitis pipeline landscape. It covers the NASH Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the NASH Pipeline Therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Discover the latest drugs and treatment options in the NASH Pipeline. Dive into DelveInsight’s comprehensive report today! @ NASH Pipeline Outlook

Key Takeaways from the NASH Pipeline Report

• In May 2025, Novo Nordisk A/S announced a study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.
• In May 2025, Akero Therapeutics Inc. conducted a phase 2b study Evaluating the Safety and Efficacy of Efruxifermin in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH).
• DelveInsight’s NASH Pipeline report depicts a robust space with 80+ active players working to develop 80+ pipeline therapies for NASH treatment.
• The leading NASH Companies such as Guangdong Raynovent Biotech, Dr. Falk Pharma GmbH, Enyo Pharma, Viking Therapeutics, Eli Lilly and Company, Sagimet Biosciences, Terns, Sinew Pharma, Madrigal Pharmaceuticals, Hepion Pharmaceuticals, Poxel SA, Pfizer, CytoDyn, Altimmune, Oramed, Ltd, PharmaKing, Can-Fite Biopharma, Cirius Therapeutics and others.
• Promising NASH Pipeline Therapies such as Semaglutide, HEC96719, DA-1241, Sitagliptin, Saroglitazar Magnesium 2mg, Vonafexor, PF-06835919, BMS-986036 and others.

Stay ahead with the most recent pipeline outlook for NASH. Get insights into clinical trials, emerging therapies, and leading companies with NASH@ NASH Treatment Drugs

NASH Emerging Drugs Profile

• Lanifibranor: Inventiva Pharma

Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce antifibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor (PPAR) isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While other PPAR agonists target only one or two PPAR isoforms for activation. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH. Currently, the drug is in Phase III stage of its clinical trial for the treatment of NASH.

• MSDC-0602K: Cirius Therapeutics

MSDC-0602K, a second-generation oral insulin sensitizer, is designed to selectively modulate the mitochondrial pyruvate carrier (MPC) while minimizing direct PPAR-gamma activation. The MPC mediates at the cellular level the effects of over nutrition, a major cause of Nonalcoholic fatty liver disease NAFLD/NASH and Type 2 diabetes. In preclinical studies, modulation of the MPC has been shown to improve insulin sensitivity, lipid metabolism, and inflammation. Currently the drug is in Phase III stage of Clinical trial for the treatment of NASH.

• TERN-501: Terns Pharmaceuticals

TERN-501 is a THR-β agonist with high metabolic stability, enhanced liver distribution and greater selectivity for THR-β compared to other THR-β agonists in development. Agonism of THR-β increases fatty acid metabolism via mitochondrial oxidation and affects cholesterol synthesis and metabolism. As a result, THR-β stimulation has the ability to reduce hepatic steatosis and improve serum lipid parameters including LDL cholesterol and triglycerides. In vivo NASH studies in a rodent model have demonstrated that low-doses of TERN-501 achieved complete resolution of steatosis and reductions in serum lipids, hepatic inflammation and fibrosis. TERN-501 has high liver distribution and is 23-fold more selective for THR-β than for THR-α activation in a cell free assay, thereby minimizing the risk of cardiotoxicity and other off-target effects associated with non-selective THR stimulation. Currently, the drug is in Phase II stage of its clinical trial for the treatment of NASH.

• HTD 1801: HighTide Biopharma

The company’s lead drug candidate, HTD1801, is a first-in-class new molecular entity (ionic salt of two active moieties). It is a novel orally active ionic salt of berberine and ursodeoxycholic acid, substantially reduced liver fat while improving glycemic control and other cardiometabolic biomarkers in adults with nonalcoholic steatohepatitis (NASH) and type 2 diabetes (T2DM). Currently, it is in Phase II trials for the treatment of primary sclerosing cholangitis (PSC), and nonalcoholic steatohepatitis (NASH).

The NASH Pipeline Report Provides Insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of NASH with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for NASH Treatment.
• NASH Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• NASH Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the NASH market

Explore groundbreaking therapies and clinical trials in the NASH Pipeline. Access DelveInsight’s detailed report now! @ New NASH Drugs

NASH Companies

Guangdong Raynovent Biotech, Dr. Falk Pharma GmbH, Enyo Pharma, Viking Therapeutics, Eli Lilly and Company, Sagimet Biosciences, Terns, Sinew Pharma, Madrigal Pharmaceuticals, Hepion Pharmaceuticals, Poxel SA, Pfizer, CytoDyn, Altimmune, Oramed, Ltd, PharmaKing, Can-Fite Biopharma, Cirius Therapeutics and others.

Nonalcoholic Steatohepatitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

NASH Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Unveil the future of NASH Treatment. Learn about new drugs, NASH Pipeline developments, and key companies with DelveInsight’s expert analysis @ NASH Market Drivers and Barriers

Scope of the NASH Pipeline Report

• Coverage- Global
• NASH Companies- Guangdong Raynovent Biotech, Dr. Falk Pharma GmbH, Enyo Pharma, Viking Therapeutics, Eli Lilly and Company, Sagimet Biosciences, Terns, Sinew Pharma, Madrigal Pharmaceuticals, Hepion Pharmaceuticals, Poxel SA, Pfizer, CytoDyn, Altimmune, Oramed, Ltd, PharmaKing, Can-Fite Biopharma, Cirius Therapeutics and others.
• NASH Pipeline Therapies- Semaglutide, HEC96719, DA-1241, Sitagliptin, Saroglitazar Magnesium 2mg, Vonafexor, PF-06835919, BMS-986036 and others.
• NASH Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• NASH Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on NASH Pipeline Therapies and clinical trials. Download DelveInsight’s in-depth pipeline report today! @ NASH Companies, Key Products and Unmet Needs

Table of Contents

1. Introduction
2. Executive Summary
3. Nonalcoholic Steatohepatitis: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Nonalcoholic Steatohepatitis– DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. Lanifibranor: Inventiva Pharma
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. TERN-501: Terns Pharmaceuticals
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. LY3849891: Eli Lilly and Company
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug name : Company name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. Nonalcoholic Steatohepatitis Key Companies
21. Nonalcoholic Steatohepatitis Key Products
22. Nonalcoholic Steatohepatitis- Unmet Needs
23. Nonalcoholic Steatohepatitis- Market Drivers and Barriers
24. Nonalcoholic Steatohepatitis- Future Perspectives and Conclusion
25. Nonalcoholic Steatohepatitis Analyst Views
26. Nonalcoholic Steatohepatitis Key Companies
27. Appendix

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