Non-Alcoholic Steatohepatitis Pipeline Set for Transformational Expansion by 2026 with 75+ Therapies, Strong Clinical Momentum from Novo Nordisk, Viking Therapeutics, Inventiva Pharma | DelveInsight
The Non-Alcoholic Steatohepatitis (NASH) therapeutic landscape is entering a pivotal phase of innovation and clinical acceleration, driven by an expanding pipeline and increasing scientific understanding of disease biology. Companies such as Novo Nordisk, Viking Therapeutics, Inventiva Pharma, GlaxoSmithKline, and Haisco Pharmaceutical Group are at the forefront of reshaping the future of NASH treatment through targeted drug development and strategic collaborations.
DelveInsight’s “Non-Alcoholic Steatohepatitis Pipeline Insight, 2026” report provides a comprehensive evaluation of the evolving NASH pipeline, covering 70+ companies and 75+ pipeline drugs across various stages of development. The report offers detailed insights into clinical and nonclinical candidates, therapeutic segmentation by product type, development stage, route of administration, and molecule type, along with an assessment of inactive and discontinued programs.
Discover how emerging therapies are transforming the treatment landscape of NASH and addressing critical unmet needs: Non-Alcoholic Steatohepatitis Clinical Trial Analysis
Key Takeaways from the Non-Alcoholic Steatohepatitis Pipeline Report
- The NASH pipeline demonstrates strong growth with over 75 active therapeutic candidates across multiple development stages.
- Increasing focus on metabolic regulation and fibrosis reversal is reshaping treatment paradigms.
- Advanced biologics and small molecules are driving innovation in disease-modifying therapies.
- Strategic collaborations, licensing deals, and mergers are accelerating clinical development timelines.
- Non-invasive diagnostics and biomarker-driven trials are improving patient stratification.
- Combination therapies are emerging as a promising approach to address disease complexity.
- Precision medicine and AI-driven drug discovery are expected to enhance therapeutic outcomes.
- In January 2026, Sagimet Biosciences announced that it would present a poster at the 10th Annual MASH-TAG Conference highlighting anti-fibrotic effects observed in F3 and qFibrosis stage 4 MASH patients from the Phase IIb FASCINATE-2 trial evaluating denifanstat.
- In November 2025, Akero Therapeutics reported additional Phase IIb SYMMETRY and HARMONY analyses at the AASLD Liver Meeting, further supporting efruxifermin’s antifibrotic effect and demonstrating alignment between digital and conventional pathology findings.
- In Sept 2025, Echosens announced FDA CDER acceptance of its Letter of Intent to qualify Liver Stiffness Measurement by FibroScan® as a surrogate endpoint in clinical trials for metabolic dysfunction-associated steatohepatitis (MASH).
- In August 2025, Madrigal Pharmaceuticals announced that the European Commission granted conditional marketing authorization for Rezdiffra (resmetirom) to treat adults with noncirrhotic MASH with moderate to advanced liver fibrosis. Rezdiffra is now the first and only approved MASH therapy in the EU.
- In May 2025, Novo Nordisk announced that it will present new data from its portfolio in metabolic and cardiovascular health at the 32nd European Congress on Obesity (ECO) from May 11–14, 2025. The data will include real-world evidence studies on semaglutide, additional analysis of the SELECT cardiovascular outcomes trial, and part 1 of the phase 3 ESSENCE trial for metabolic dysfunction-associated steatohepatitis (MASH).
- In May 2025, Roche announced the launch of its Elecsys® PRO-C3 test, a new diagnostic solution designed to assess the severity of liver fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Developed in collaboration with Nordic Bioscience, the test provides clinicians with a simple and efficient way to identify patients with liver fibrosis of varying severity, facilitating timely intervention and management of the disease.
Stay ahead with in-depth pipeline analytics and competitive intelligence: Non-Alcoholic Steatohepatitis Pipeline Outlook
Understanding Non-Alcoholic Steatohepatitis: A Progressive and Complex Liver Disorder
Non-Alcoholic Steatohepatitis (NASH) represents a severe and progressive form of non-alcoholic fatty liver disease (NAFLD), characterized by hepatic fat accumulation, inflammation, and cellular injury. The disease progresses through multiple clinical stages, beginning with simple steatosis and advancing to inflammation, fibrosis, cirrhosis, and eventually hepatocellular carcinoma in severe cases.
One of the most challenging aspects of NASH is its silent progression. Many patients remain asymptomatic during the early stages, often presenting only with mild fatigue or discomfort in the upper abdomen. As the disease advances, more severe manifestations such as jaundice, ascites, sarcopenia, and complications associated with portal hypertension begin to emerge, significantly impacting patient outcomes and survival.
The pathophysiology of NASH is multifactorial and involves complex interactions between metabolic dysfunction, insulin resistance, lipid dysregulation, and chronic inflammation. Excess free fatty acids in the liver contribute to oxidative stress, mitochondrial dysfunction, and activation of inflammatory pathways, ultimately leading to fibrosis and liver damage. Additionally, emerging evidence highlights the role of gut microbiota and genetic predisposition in disease progression.
Diagnosing NASH remains a significant clinical challenge. While liver biopsy continues to be the gold standard, its invasive nature limits widespread adoption. Consequently, non-invasive diagnostic approaches such as imaging techniques (MRI-PDFF, CAP) and serum biomarkers are gaining traction. Despite advancements in diagnostics, effective pharmacological treatments remain limited, underscoring the urgent need for innovative therapeutic solutions.
Evolving NASH Pipeline Landscape: Innovation Driving Therapeutic Breakthroughs
The NASH pipeline is undergoing a significant transformation, with a strong emphasis on targeting underlying disease mechanisms rather than symptomatic relief. Advances in molecular biology, metabolic research, and fibrosis pathways have paved the way for next-generation therapies designed to halt or reverse disease progression.
Gain exclusive insights into pipeline dynamics and clinical innovations shaping the NASH market: Non-Alcoholic Steatohepatitis Competitive Landscape
The report highlights that over 70 companies are actively engaged in developing therapies for NASH, collectively contributing to a pipeline of more than 75 drug candidates. These therapies span early discovery to late-stage clinical trials, reflecting a robust and diversified R&D ecosystem.
Key Non-Alcoholic Steatohepatitis therapeutic approaches being explored include:
- Fibroblast growth factor (FGF) analogs targeting metabolic regulation
- Thyroid hormone receptor-beta (THR-β) agonists for lipid metabolism
- Anti-inflammatory and antifibrotic agents
- Metabolic modulators addressing insulin resistance
- Microbiome-based therapies and combination approaches
Non-Alcoholic Steatohepatitis Emerging Drugs Profile
Efruxifermin: Novo Nordisk
Efruxifermin (EFX) is an advanced Fc-FGF21 fusion protein designed to replicate the biological activity of native FGF21. The therapy targets multiple aspects of NASH pathophysiology, including reduction of liver fat, inflammation, and fibrosis, while improving insulin sensitivity and lipid metabolism. Currently in Phase III clinical trials, Efruxifermin represents a promising disease-modifying therapy with the potential to address both hepatic and cardiovascular risks associated with NASH.
HSK-31679: Haisco Pharmaceutical Group Co., Ltd.
HSK-31679 is a novel, orally active thyroid hormone receptor-beta agonist aimed at reducing liver fat and inflammation. By modulating lipid metabolism and influencing gut microbiota, the drug demonstrates superior preclinical efficacy compared to earlier candidates. It is currently being evaluated in Phase II clinical trials.
VK2809: Viking Therapeutics
VK2809 is a selective THR-β agonist designed for liver-targeted activity. The drug has shown promising results in Phase IIb trials, achieving both primary and secondary endpoints in patients with biopsy-confirmed NASH and fibrosis. Its oral formulation and targeted mechanism make it a strong contender in the competitive NASH pipeline.
B1344: Tasly Biopharmaceuticals Co., Ltd.
B1344 is a long-acting PEGylated FGF21 analog developed to treat metabolic liver diseases. Preclinical studies have demonstrated significant reductions in hepatic steatosis, inflammation, and fibrosis. The therapy is currently progressing through Phase I clinical development.
ACT500: Xiamen Amoytop Biotech Co., Ltd.
ACT500 is an investigational candidate undergoing early-stage clinical evaluation for safety and pharmacokinetics. The drug targets metabolic dysfunction associated with NASH and represents a novel addition to the early-stage pipeline.
Explore complete drug profiles and clinical updates: Non-Alcoholic Steatohepatitis Clinical Trial and FDA Approval
NASH Pipeline Segmentation and Therapeutic Assessment
The report provides a detailed segmentation of pipeline therapies across multiple parameters:
Non-Alcoholic Steatohepatitis Clinical Development Phases
- Late-stage (Phase III)
- Mid-stage (Phase II)
- Early-stage (Phase I)
- Preclinical and discovery-stage candidates
- Inactive and discontinued programs
Non-Alcoholic Steatohepatitis Route of Administration
- Oral
- Intravenous
- Subcutaneous
- Parenteral
- Topical
Non-Alcoholic Steatohepatitis Molecule Types
- Small molecules
- Monoclonal antibodies
- Peptides
- Recombinant fusion proteins
- Gene therapies
- Polymer-based therapeutics
Non-Alcoholic Steatohepatitis Product Types
- Monotherapy
- Combination therapy
- Mono/Combination approaches
This diversified therapeutic landscape reflects the complexity of NASH and the need for multi-targeted treatment strategies.
Non-Alcoholic Steatohepatitis Clinical Trial and Development Activities in NASH
The NASH pipeline is characterized by increasing clinical trial activity across global markets. Companies are actively pursuing partnerships, licensing agreements, and mergers to enhance their research capabilities and accelerate commercialization timelines.
Key players such as Novo Nordisk, Viking Therapeutics, and Inventiva Pharma are leading clinical advancements with late-stage candidates, while emerging biotech firms are exploring innovative mechanisms such as metabolic reprogramming and antifibrotic targeting.
Non-Alcoholic Steatohepatitis Market Drivers, Challenges, and Future Outlook
The growth of the NASH pipeline is driven by several key factors, including rising global prevalence of metabolic disorders, increasing awareness, and advancements in diagnostic technologies. The growing burden of obesity and type 2 diabetes is further accelerating the demand for effective NASH therapies.
However, the market faces several challenges:
- Lack of approved targeted therapies
- Complexity of disease pathogenesis
- Variability in patient response
- Dependence on invasive diagnostic methods
Despite these hurdles, the future outlook for NASH remains highly promising. Advances in biomarker discovery, artificial intelligence, and precision medicine are expected to revolutionize treatment approaches and improve patient outcomes.
Unlock insights into clinical trials, collaborations, and strategic developments: Non-Alcoholic Steatohepatitis Companies and Medication
Scope of the Non-Alcoholic Steatohepatitis Pipeline Report
- Coverage: Global
- Key NASH Companies: Novo Nordisk, Viking Therapeutics, Inventiva Pharma, GlaxoSmithKline, Haisco Pharmaceutical Group, and others
- Key NASH Therapies: Efruxifermin, VK2809, Lanifibranor, Miricorilant, Tesamorelin, and more
- Therapeutic Assessment: By product type, stage, route of administration, and molecule type
Table of Contents
- Introduction
- Executive Summary
- NASH Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Analytical Perspective
- Late-Stage Products
- Mid-Stage Products
- Early-Stage Products
- Inactive Products
- Key Companies
- Key Products
- Unmet Needs
- Market Drivers and Barriers
- Future Perspectives
About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.
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