DelveInsight’s, “Nonalcoholic Steatohepatitis Pipeline Insight, 2025” 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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NASH Emerging Drugs Profile
Semaglutide, developed by Novo Nordisk, is a Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) being explored for the treatment of liver fibrosis and Non-Alcoholic Fatty Liver Disease (NAFLD). It aims to improve liver histology and promote NAFLD resolution. Semaglutide has demonstrated improvements in lipid profiles, liver steatosis, and fibrosis parameters, as well as reductions in BMI among patients with type 2 diabetes and obesity with NAFLD. Semaglutide exerts beneficial effects on NAFLD through several mechanisms. It enhances incretin function by activating GLP-1 receptors. Beyond weight loss-related benefits, semaglutide has antioxidative effects and reduces mitochondrial damage, which plays a central role in the pathogenesis and progression of NAFLD. Additionally, it has anti-inflammatory effects, inhibiting the upregulation of pro-inflammatory factors and down-regulating the expression of inflammatory factors. Novo Nordisk also announced that the US Food and Drug Administration has accepted the supplemental New Drug Application (sNDA) and granted Priority Review for Wegovy® (semaglutide) injection 2.4 mg to treat noncirrhotic MASH in adults with moderate to advanced liver scarring (fibrosis). Currently, the drug is registered for the treatment of Non-Alcoholic Steatohepatitis (NASH).
Aramchol (Arachidyl Amido Cholanoic Acid) is a first-in-class, novel synthetic small molecule, a conjugate of Cholic Acid and Arachidic Acid, liver targeted SCD1 modulator, developed as an oral therapy for the treatment of NASH (Nonalcoholic Steatohepatitis) and fibrosis. Aramchol’s ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation, and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells. Aramchol, by targeting this single receptor, induces a cascade of events that leads to two main changes; in hepatocytes, Aramchol elevates the fatty acids oxidation (or in other words – fat burn) and influences AMPK, which results also in reducing glycemic parameters; and in hepatic stellate cells, Aramchol has been shown to down-regulate the expression and activity of stearoyl-CoA desaturase-1 (SCD-1), resulting in a direct effect on fibrogenesis. Currently, the drug is in Phase III stage of its development for the treatment of Non-Alcoholic Steatohepatitis (NASH).
Survodutide is an innovative dual GLP-1/glucagon receptor agonist designed to address metabolic dysfunction and liver disorders. By targeting key metabolic pathways, Survodutide helps regulate glucose metabolism, lipid accumulation, and inflammatory responses, which are critical factors in the progression of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). This therapeutic approach aims to reduce liver fat, improve insulin sensitivity, and support liver health, making it a potential treatment option for patients at risk of liver fibrosis and cirrhosis. As part of the evolving landscape of metabolic and liver disease management, Survodutide represents a novel strategy for addressing liver dysfunction while promoting overall metabolic balance. Currently, the drug is in Phase III stage of its development for the treatment of Non-Alcoholic Steatohepatitis (NASH).
AZD2693 is a liver-targeted antisense oligonucleotide against PNPLA3 mRNA. AZD2693 lowers the mRNA expression of PNPLA3 in patients that are homozygotes for the 148M risk allele thereby reducing an important disease driver for NASH. AZD2693 has been evaluated in 3-month repeat dose subcutaneous toxicity study in preclinical species. Findings were consistent with typical class effects of ASOs, including histiocytic infiltration in multiple tissues and evidence of ASO accumulation in liver and spleen. No effects were attributed to the reduction in PNPLA3. Preclinical safety pharmacology studies have also been conducted with no effects on the respiratory, cardiovascular, and central and peripheral nervous systems. Under preclinical pharmacology, Murine PNPLA3 tool ASO has been shown to reduce liver steatosis, inflammation and fibrosis in homozygous PNPLA3 148M knock-in mice. Currently, the drug is in Phase II stage of its development for the treatment of Non-Alcoholic Steatohepatitis (NASH).
ALN-HSD is an investigational, subcutaneously administered RNAi therapeutic targeting HSD17B13 for the treatment of NASH. It is being developed by Regeneron in collaboration with Alnylam Pharmaceuticals following the identification of a loss-of-function variant in HSD17B13 that is associated with a reduced risk of chronic liver disease and progression from steatosis to steatohepatitis. Studies have shown that Individuals with two copies of the loss-of-function variant in the HSD17B13 gene, which encodes the hepatic lipid droplet protein hydroxysteroid 17-beta dehydrogenase 13, had lower risk of alcoholic cirrhosis and nonalcoholic cirrhosis than individuals with two functioning copies of the gene. These individuals also had lower risk of alcoholic liver disease and 30 percent lower risk of nonalcoholic liver disease than people with functioning copies of the gene. The variant is also associated with a reduced risk of NASH, suggesting that loss of HSD17B13 function protects from progression to later, more clinically-impactful stages of liver disease. Currently, the drug is in Phase II 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
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
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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