Non-alcoholic Steatohepatitis (NASH) Pipeline constitutes 80+ key companies continuously working towards developing 80+ Non-alcoholic Steatohepatitis (NASH) treatment therapies, analyzes DelveInsight.
Non-alcoholic Steatohepatitis (NASH) Overview:
Nonalcoholic steatohepatitis (NASH) is a liver disorder marked by inflammation and liver cell damage resulting from excess fat accumulation in the liver. It is a subtype of nonalcoholic fatty liver disease (NAFLD), which includes two main forms: simple fatty liver (fat accumulation without inflammation) and NASH (fat buildup with inflammation and liver injury). NASH can progress to serious complications such as liver fibrosis, cirrhosis, and liver cancer, with about 30–40% of patients developing fibrosis. Though commonly associated with NAFLD, NASH can also occur alongside other liver conditions like chronic hepatitis C.
NASH is classified into primary (typically related to obesity and type 2 diabetes in the absence of significant alcohol use) and secondary (caused by medications or toxins). Major risk factors include obesity, metabolic syndrome, insulin resistance, and type 2 diabetes. Other related conditions include polycystic ovary syndrome, Wilson disease, and lipodystrophies.
The disease progression is often explained by the “two-hit” model: the first hit involves fat accumulation in the liver (steatosis), while the second hit triggers oxidative stress and liver cell injury, leading to inflammation, mitochondrial dysfunction, and eventually fibrosis or cirrhosis. NASH is often identified incidentally through abnormal liver function tests or imaging. Although liver biopsy remains the most accurate diagnostic tool, non-invasive methods such as FibroScan and APRI scores are increasingly used to evaluate liver damage.
Management of NASH is centered on lifestyle interventions like weight loss (5%–10%), regular exercise, and dietary changes—particularly reducing fructose intake and increasing omega-3 fatty acids. Some medications, including vitamin E and thiazolidinediones, may offer benefits, though the latter require caution. Bariatric surgery is considered for patients with severe obesity, and liver transplantation may be necessary for those with end-stage liver disease, despite the potential for NASH recurrence post-transplant.
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“Non-alcoholic Steatohepatitis (NASH) Pipeline Insight 2025” report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Non-alcoholic Steatohepatitis (NASH) Therapeutics Market.
Key Takeaways from the Non-alcoholic Steatohepatitis (NASH) Pipeline Report
DelveInsight’s Non-alcoholic Steatohepatitis (NASH) pipeline report depicts a robust space with 80+ active players working to develop 80+ pipeline therapies for Non-alcoholic Steatohepatitis (NASH) treatment.
In November 2025, Novo Nordisk announced positive results for semaglutide in treating Nonalcoholic Steatohepatitis (NASH). The Phase 3 Essence trial showed that a once-weekly 2.4 mg dose of semaglutide significantly improved liver fibrosis and resolved steatohepatitis in NASH patients with stage 2 or 3 fibrosis, without worsening liver fibrosis, successfully meeting the primary endpoints.
In October 2025, Sagimet Biosciences (SGMT) revealed the successful conclusion of end-of-Phase 2 discussions with the FDA, allowing denifanstat to move forward into Phase 3 clinical trials for metabolic dysfunction-associated steatohepatitis.
In July 2025, Inventiva provided updates on its Phase III NATiV3 clinical program, assessing lanifibranor for treating metabolic dysfunction-associated steatohepatitis/non-alcoholic steatohepatitis (MASH/NASH). Recruitment for the trial is currently underway at 347 sites across 19 countries.
Key Non-alcoholic Steatohepatitis (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 are evaluating new drugs for Non-alcoholic Steatohepatitis (NASH) to improve the treatment landscape.
Promising Non-alcoholic Steatohepatitis (NASH) pipeline therapies in various stages of development include Lanifibranor, MSDC-0602K, TERN-501, HTD 1801, and others.
Non-alcoholic Steatohepatitis (NASH) Pipeline Analysis
The report provides insights into:
The report provides detailed insights into the key companies that are developing therapies in the Non-alcoholic Steatohepatitis (NASH) Market.
The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Non-alcoholic Steatohepatitis (NASH) treatment.
It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
It navigates the emerging 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 Non-alcoholic Steatohepatitis (NASH) market.
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Non-alcoholic Steatohepatitis (NASH) Emerging Drugs
Lanifibranor: Inventiva Pharma
MSDC-0602K: Cirius Therapeutics
TERN-501: Terns Pharmaceuticals
HTD 1801: HighTide Biopharma
Non-alcoholic Steatohepatitis (NASH) Companies
More than 80 prominent companies are actively developing treatments for Nonalcoholic Steatohepatitis (NASH). Among these, Cirius Therapeutics and Inventiva Pharma have the most advanced drug candidates, currently in Phase III clinical trials.
DelveInsight’s report covers around 22+ products under different phases of clinical development like
Late stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I) along with the details of
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
Non-alcoholic Steatohepatitis (NASH) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
Intravenous
Subcutaneous
Oral
Intramuscular
Non-alcoholic Steatohepatitis (NASH) Products have been categorized under various Molecule types such as
Monoclonal antibody
Small molecule
Peptide
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Non-alcoholic Steatohepatitis (NASH) Pipeline Therapeutic Assessment
• Non-alcoholic Steatohepatitis (NASH) Assessment by Product Type
• Non-alcoholic Steatohepatitis (NASH) By Stage
• Non-alcoholic Steatohepatitis (NASH) Assessment by Route of Administration
• Non-alcoholic Steatohepatitis (NASH) Assessment by Molecule Type
Download Non-alcoholic Steatohepatitis (NASH) Sample report to know in detail about the Non-alcoholic Steatohepatitis (NASH) treatment market @ Non-alcoholic Steatohepatitis (NASH) Therapeutic Assessment
Table of Content
1. Report Introduction
2. Executive Summary
3. Non-alcoholic Steatohepatitis (NASH) Current Treatment Patterns
4. Non-alcoholic Steatohepatitis (NASH) – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
6. Non-alcoholic Steatohepatitis (NASH) Late-Stage Products (Phase-III)
7. Non-alcoholic Steatohepatitis (NASH) Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Non-alcoholic Steatohepatitis (NASH) Discontinued Products
13. Non-alcoholic Steatohepatitis (NASH) Product Profiles
14. Non-alcoholic Steatohepatitis (NASH) Key Companies
15. Non-alcoholic Steatohepatitis (NASH) Key Products
16. Dormant and Discontinued Products
17. Non-alcoholic Steatohepatitis (NASH) Unmet Needs
18. Non-alcoholic Steatohepatitis (NASH) Future Perspectives
19. Non-alcoholic Steatohepatitis (NASH) Analyst Review
20. Appendix
21. Report Methodology
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