non alcoholic steatohepatitis nash pipeline insight

DelveInsight’s, “Non-Alcoholic Steatohepatitis (NASH) - Pipeline Insight, 2025” report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in Non-Alcoholic Steatohepatitis (NASH) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

 

Geography Covered

• Global coverage

 

Non-Alcoholic Steatohepatitis (NASH): Understanding

Non-Alcoholic Steatohepatitis (NASH): Overview

Nonalcoholic steatohepatitis (NASH) is a progressive form of nonalcoholic fatty liver disease (NAFLD) characterized by liver inflammation, hepatocyte injury, and fat accumulation in the absence of significant alcohol intake. It is most commonly associated with metabolic conditions such as obesity, type 2 diabetes, and insulin resistance. NASH can lead to serious liver complications, including fibrosis, cirrhosis, and hepatocellular carcinoma, with up to 40% of patients developing some degree of fibrosis. While minor fat deposition in the liver may occur in healthy individuals, NASH is considered pathologic when steatosis affects at least 5% of hepatocytes and is accompanied by inflammation and cellular injury. Primary NASH, which this discussion focuses on, arises in the setting of metabolic dysfunction and is distinct from secondary forms caused by drugs or toxins.

 

In its early stages, NASH may present with subtle symptoms such as persistent fatigue, vague discomfort or dull pain in the upper right abdomen, nausea, and a reduced appetite. As the disease progresses, particularly when cirrhosis develops, symptoms become more pronounced and may include yellowing of the skin and eyes (jaundice), abdominal swelling due to fluid accumulation (ascites), and swelling in the legs and feet (edema). Patients may also show signs like spider-like blood vessels on the skin, easy bruising or bleeding, intense skin itching, and cognitive or behavioral changes such as confusion or drowsiness. Additional complications in advanced stages can include an enlarged spleen, red palms, shortness of breath, and dangerous bleeding from esophageal varices.

 

Nonalcoholic steatohepatitis (NASH) is a progressive form of NAFLD marked by liver fat accumulation, inflammation, and cell injury. Its development is often explained by the ""two-hit"" hypothesis: the first hit is fat buildup due to insulin resistance and energy surplus, and the second involves oxidative stress, mitochondrial dysfunction, and inflammation. While triglyceride storage in liver cells may be protective, toxic fat metabolites like saturated fatty acids and ceramides cause cell damage, leading to apoptosis, fibrosis, and possibly cirrhosis. Most patients are asymptomatic, but some may report upper right abdominal discomfort. On exam, findings may include hepatomegaly, acanthosis nigricans, or signs of advanced liver disease such as jaundice and ascites.

 

The cornerstone of NASH treatment is lifestyle modification aimed at achieving 5–10% weight loss through calorie reduction and regular exercise, which has been shown to improve liver function and histology. Dietary changes such as reducing high fructose corn syrup and increasing omega-3 fatty acid intake are beneficial, and moderate coffee consumption may reduce fibrosis risk. Pharmacologic options include thiazolidinediones, which improve insulin sensitivity but have notable side effects, and vitamin E, which may help in non-diabetic patients at a dose of 800 IU/day. Bariatric surgery is effective for eligible patients with morbid obesity, and statins are safe to use in NAFLD despite abnormal liver tests. In advanced cases with decompensated cirrhosis, liver transplantation may be necessary, though NASH can recur post-transplant.

 

"Non-Alcoholic Steatohepatitis (NASH) - Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Non-Alcoholic Steatohepatitis (NASH) pipeline landscape is provided which includes the disease overview and Non-Alcoholic Steatohepatitis (NASH) treatment guidelines. The assessment part of the report embraces, in depth Non-Alcoholic Steatohepatitis (NASH) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Non-Alcoholic Steatohepatitis (NASH) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

 

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Non-Alcoholic Steatohepatitis (NASH) R&D. The therapies under development are focused on novel approaches to treat/improve Non-Alcoholic Steatohepatitis (NASH).

 

Non-Alcoholic Steatohepatitis (NASH) Emerging Drugs Chapters

This segment of the Non-Alcoholic Steatohepatitis (NASH) report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

 

Non-Alcoholic Steatohepatitis (NASH) Emerging Drugs

• Semaglutide: Novo Nordisk A/S

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: Galmed Pharmaceuticals

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: Boehringer Ingelheim

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: AstraZeneca

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: Regeneron Pharmaceuticals

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).

Further product details are provided in the report……..

 

Non-Alcoholic Steatohepatitis (NASH): Therapeutic Assessment

This segment of the report provides insights about the different Non-Alcoholic Steatohepatitis (NASH) drugs segregated based on following parameters that define the scope of the report, such as:

Major  Players in Non-Alcoholic Steatohepatitis (NASH)

There are approx. 70+ key companies which are developing the therapies for Non-Alcoholic Steatohepatitis (NASH). The companies which have their Non-Alcoholic Steatohepatitis (NASH) drug candidates in the most advanced stage, i.e. Registration include, Novo Nordisk A/S.

 

Phases

DelveInsight’s report covers around 75+ 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

 

Route of Administration

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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

 

Molecule Type

Products have been categorized under various Molecule types such as

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

 

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

 

Non-Alcoholic Steatohepatitis (NASH): Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Non-Alcoholic Steatohepatitis (NASH) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Non-Alcoholic Steatohepatitis (NASH) drugs.

 

Non-Alcoholic Steatohepatitis (NASH) Report Insights

• Non-Alcoholic Steatohepatitis (NASH) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Non-Alcoholic Steatohepatitis (NASH) Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

 

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Non-Alcoholic Steatohepatitis (NASH) drugs?
• How many Non-Alcoholic Steatohepatitis (NASH) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Non-Alcoholic Steatohepatitis (NASH)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Non-Alcoholic Steatohepatitis (NASH) therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Non-Alcoholic Steatohepatitis (NASH) and their status?
• What are the key designations that have been granted to the emerging drugs?

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