Nonalcoholic Steatohepatitis Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
DelveInsight's, ' Nonalcoholic Steatohepatitis Pipeline Insight ' report provides comprehensive insights about 80+ companies and 80+ pipeline drugs in Nonalcoholic Steatohepatitis pipeline landscape. It covers the Nonalcoholic Steatohepatitis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Nonalcoholic Steatohepatitis therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Nonalcoholic Steatohepatitis Treatment Landscape. Click here to read more @ Nonalcoholic Steatohepatitis Pipeline Outlook
Key Takeaways from the Nonalcoholic Steatohepatitis Pipeline Report
In March 2025, Zydus Therapeutics Inc. announced a study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis.
In March 2025, Novo Nordisk A/S conducted the 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 March 2025, 89Bio Inc, announced the study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH [previously known as nonalcoholic steatohepatitis, NASH]).
DelveInsight's Nonalcoholic Steatohepatitis Pipeline analysis depicts a robust space with 80+ active players working to develop 80+ pipeline treatment therapies.
DelveInsight's Nonalcoholic Steatohepatitis pipeline report depicts a robust space with 80+ active players working to develop 80+ pipeline therapies for Nonalcoholic Steatohepatitis treatment.
The leading Nonalcoholic Steatohepatitis 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 Nonalcoholic Steatohepatitis Therapies such as AZD2693, Saroglitazar Magnesium 4 mg, Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR), and others.
Discover groundbreaking developments in Nonalcoholic Steatohepatitis therapies! Gain in-depth knowledge of key Nonalcoholic Steatohepatitis clinical trials, emerging drugs, and market opportunities @ Nonalcoholic Steatohepatitis Clinical Trials Assessment
Nonalcoholic Steatohepatitis 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 Nonalcoholic Steatohepatitis Pipeline report provides insights into
The report provides detailed insights about companies that are developing therapies for the treatment of Nonalcoholic Steatohepatitis 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 Nonalcoholic Steatohepatitis Treatment.
Nonalcoholic Steatohepatitis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
Nonalcoholic Steatohepatitis 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 Nonalcoholic Steatohepatitis market
Stay informed about the Nonalcoholic Steatohepatitis pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Nonalcoholic Steatohepatitis Unmet Needs
Nonalcoholic Steatohepatitis 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
Oral
Intravenous
Subcutaneous
Parenteral
Topical
Nonalcoholic Steatohepatitis Products have been categorized under various Molecule types such as
Recombinant fusion proteins
Small molecule
Monoclonal antibody
Peptide
Polymer
Gene therapy
Transform your understanding of the Nonalcoholic Steatohepatitis Pipeline! See the latest progress in drug development and clinical research @ Nonalcoholic Steatohepatitis Market Drivers and Barriers, and Future Perspectives
Scope of the Nonalcoholic Steatohepatitis Pipeline Report
Coverage - Global
Nonalcoholic Steatohepatitis 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 Therapies - AZD2693, Saroglitazar Magnesium 4 mg, Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR), and others.
Nonalcoholic Steatohepatitis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
Nonalcoholic Steatohepatitis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Stay Ahead in Oncology Research–Access the Full Nonalcoholic Steatohepatitis Pipeline Analysis Today! @ Nonalcoholic Steatohepatitis Drugs and Companies
Table of Content
Introduction
Executive Summary
Nonalcoholic Steatohepatitis: Overview
Pipeline Therapeutics
Therapeutic Assessment
Nonalcoholic Steatohepatitis– DelveInsight's Analytical Perspective
Late Stage Products (Phase III)
Lanifibranor: Inventiva Pharma
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
TERN-501: Terns Pharmaceuticals
Drug profiles in the detailed report…..
Early Stage Products (Phase I)
LY3849891: Eli Lilly and Company
Drug profiles in the detailed report…..
Preclinical and Discovery Stage Products
Drug name : Company name
Drug profiles in the detailed report…..
Inactive Products
Nonalcoholic Steatohepatitis Key Companies
Nonalcoholic Steatohepatitis Key Products
Nonalcoholic Steatohepatitis- Unmet Needs
Nonalcoholic Steatohepatitis- Market Drivers and Barriers
Nonalcoholic Steatohepatitis- Future Perspectives and Conclusion
Nonalcoholic Steatohepatitis Analyst Views
Nonalcoholic Steatohepatitis Key Companies
Appendix
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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