DelveInsight’s, “Nonalcoholic Steatohepatitis Pipeline Insight, 2026” report provides comprehensive insights about 70+ companies and 75+ 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.
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Key Takeaways from the NASH Pipeline Report
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Non-Alcoholic Steatohepatitis Overview
Non-alcoholic steatohepatitis (NASH) is a severe form of non-alcoholic fatty liver disease (NAFLD), characterized by the presence of liver inflammation and hepatocyte injury (ballooning) due to fat accumulation. There are four different clinical phases described for NAFLD. Phase 1 is characterized by simple steatosis and is considered harmless. Some patients progress to Phase 2 developing inflammation and ballooning (NASH). Phase 3 is defined by the presence of NASH with persistent inflammation resulting in liver fibrosis (scarring), which is considered the strongest predictor of liver-related events in NASH patients. Over time, this 3rd stage can lead to a more serious condition, such as liver cirrhosis (Phase 4) or even cancer, where a liver transplant is the only therapy option.
NASH Emerging Drugs Profile
Efruxifermin (EFX) is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX appears to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipid metabolism. This holistic approach offers the potential to address the complex, multi-system disease state of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease the leading cause of death in MASH patients. Currently, the drug is being evaluated in the Phase III stage of its development for the treatment of Non-Alcoholic Steatohepatitis (NASH).
HSK31679 is a novel, liver-directed, orally active thyroid hormone receptor-beta agonist designed to treat Metabolic Dysfunction-Associated Steatohepatitis (MASH/NASH) and liver fibrosis. It shows superior preclinical efficacy in reducing liver fat and inflammation compared to MGL-3196 (Resmetirom) by modulating gut microbial sphingolipids and inducing an anti-inflammatory environment. Currently, the drug is being evaluated in the Phase II stage of its development for the treatment of Non-Alcoholic Steatohepatitis (NASH).
VK2809, is a novel, orally available small molecule thyroid hormone receptor agonist that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promise for the treatment of metabolic disorders, including non-alcoholic steatohepatitis (NASH). The compound successfully achieved both the primary and secondary endpoints in a Phase IIb study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis.
B1344 is a novel, long-acting polyethylene glycolylated (PEGylated) fibroblast growth factor 21 (FGF21) analog developed for treating nonalcoholic steatohepatitis (NASH) and metabolic diseases. B1344 is sufficient to selectively activate signaling from the βKlotho/FGFR1c receptor complex. In cynomolgus monkeys with nonalcoholic fatty liver disease (NAFLD), administration of B1344 via subcutaneous injection for 11 weeks caused a profound reduction of hepatic steatosis, inflammation, and fibrosis, along with amelioration of liver injury and hepatocyte death, as evidenced by liver biopsy specimen and biochemical analysis. Currently, the drug is being evaluated in the Phase I stage of its development for the treatment of Non-Alcoholic Steatohepatitis (NASH).
ACT500 (formerly known as NM6606) is an investigational drug candidate being developed by Xiamen Amoytop Biotech Co., Ltd. (Amoytop Biotech), undergoing early-stage clinical trials to evaluate its safety, tolerability, and pharmacokinetics (PK) for treating metabolic liver diseases. Currently, the drug is being evaluated in the Phase I stage of its development for the treatment of Non-Alcoholic Steatohepatitis (NASH).
The NASH Pipeline Report Provides Insights into
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NASH Companies
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. 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
NASH Products have been categorized under various Molecule types such as
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Scope of the NASH Pipeline Report
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