Non-Alcoholic Steatohepatitis (NASH) - Pipeline Insight, 2026

This “Non-Alcoholic Steatohepatitis (NASH) - Pipeline Insight, 2026” 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.

Non-Alcoholic Steatohepatitis (NASH): Understanding

Non-Alcoholic Steatohepatitis (NASH): 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.

Most patients remain asymptomatic or present with nonspecific manifestations, the most commonly reported being persistent fatigue and mild discomfort or a dull ache localized to the right upper quadrant of the abdomen, corresponding to hepatic enlargement or inflammation. As emphasized in clinical observations, many individuals do not recognize any symptoms until the disease advances to NASH-related cirrhosis, at which point complications of chronic liver injury become apparent. In advanced stages, patients may develop more definitive signs of hepatic dysfunction, including jaundice, ascites, sarcopenia, and portal hypertension associated complications.

The accumulation of free fatty acids leads to insulin resistance. Loss of adipose tissue responsiveness to insulin plays a major role in the pathophysiology of NASH. Failure of insulin to inhibit triglyceride lipolysis in insulin-resistant states leads to an oversupply of free fatty acids to the liver, excess hepatic triglyceride synthesis, and intracellular accumulation of toxic lipid products that impair insulin signalling and activate inflammatory pathways. This is followed by progression to hepatic inflammation (steatohepatitis), leading to an accumulation of oxygen free radicals, mitochondrial dysfunction and formation of adipokines, all of which result in hepatic tissue damage and fibrosis. Recent data suggest that adipose-based insulin resistance is responsible for the activation of hepatic macrophages and the inflammatory process in the liver. This process is independent of a patient’s comorbid disease states of diabetes and/or obesity.

The etiology of NASH remains incompletely understood, reflecting the multifactorial and complex nature of its pathogenesis. Although it arises within the spectrum of NAFLD, only a subset of individuals with hepatic steatosis progress to the inflammatory and fibrotic phenotype characteristic of NASH, and the determinants of this transition are still being actively investigated. Current evidence suggests that a combination of genetic susceptibility, metabolic dysregulation (including insulin resistance and lipid imbalance), and alterations in the gut microbiome contribute to disease initiation and progression. These factors interact to disrupt hepatic homeostasis and promote inflammatory signaling pathways.

The diagnosis of NASH relies on liver biopsy as the gold standard due to its accuracy in assessing inflammation and fibrosis, although its invasive nature limits routine use. As a result, non-invasive approaches such as blood-based indices (FLI, HSI) and imaging techniques are increasingly used. While ultrasonography detects moderate-to-severe steatosis, advanced modalities like CAP and MRI-PDFF provide higher sensitivity, with MRI offering near-complete accuracy. Emerging serum biomarkers, including hyaluronic acid, YKL-40, TIMP-1, and PIIINP, show promise for fibrosis assessment. Pharmacological treatment options remain investigational, few agents like Vitamin E and Pioglitazone have shown benefits in selected patients. Novel therapies under development include GLP-1 receptor agonists such as Semaglutide and FXR agonists like Obeticholic acid, along with anti-inflammatory and antifibrotic agents targeting disease progression.

"Non-Alcoholic Steatohepatitis (NASH) - Pipeline Insight, 2026" report 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 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

• Efruxifermin: Novo Nordisk

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).

• HSK-31679: Haisco Pharmaceutical Group Co., Ltd.

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: Viking Therapeutics

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: Tasly Biopharmaceuticals Co., Ltd.

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: Xiamen Amoytop Biotech Co., Ltd.

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).

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. Phase III include, Novo Nordisk.

Phases

The 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 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?

Key Players

• 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.

Key Products

• Efruxifermin
• HSK-31679
• VK2809
• B1344
• ACT500
• HEC-169584
• Miricorilant
• J2H-1702
• GSK4532990
• HP515
• HU6
• VK2809
• SNP-610
• ZSP1601
• ALG-055009
• Lanifibranor
• HTD-1801
• MN-001
• Tesamorelin
• TLC-2716
• Pegozafermin
• INI-822
• IMM-H014
• TQA-2225
• Icosabutate

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