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Report Overview

Non-alcoholic fatty liver disease (NAFLD) is a metabolic liver disorder increasingly affecting younger populations. According to data from 2021 reported by the cited study, adults aged 15–49 years experienced an incidence rate of 909.48 per 100,000 persons and a prevalence of 16,580.43 per 100,000 persons, highlighting its substantial global burden. NAFLD-related mortality reached 0.45 per 100,000 persons, while disability-adjusted life years (DALYs) were 22.77 per 100,000 person-years. According to the non-alcoholic fatty liver disease (NAFLD) pipeline analysis by Expert Market Research, the demand for NAFLD therapeutics is expected to grow substantially in the coming years, driven by rising disease incidence linked to obesity, diabetes, and sedentary lifestyles. Additionally, there is an increasing research investment in metabolic, anti-inflammatory, and anti-fibrotic treatment approaches.

  • Major companies involved in the non alcoholic fatty liver disease (NAFLD) pipeline analysis include Novo Nordisk A/S and GlaxoSmithKline, and others.

  • Leading drugs currently in the pipeline include Semaglutide, B1344, and others.

  • The growth of non-alcoholic fatty liver disease (NAFLD) is driven by rising obesity, increasing metabolic disorders such as type 2 diabetes, and widespread sedentary lifestyle patterns.

Report Coverage

The Non Alcoholic Fatty Liver Disease (NAFLD) Pipeline Analysis Report by Expert Market Research gives comprehensive insights into non alcoholic fatty liver disease (NAFLD) therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for non alcoholic fatty liver disease (NAFLD). The non alcoholic fatty liver disease (NAFLD) report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The non alcoholic fatty liver disease (NAFLD) pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with non alcoholic fatty liver disease (NAFLD) treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to non alcoholic fatty liver disease (NAFLD).

Non Alcoholic Fatty Liver Disease (NAFLD) Pipeline Analysis by Drug Class

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Non Alcoholic Fatty Liver Disease (NAFLD) Pipeline Outlook

Non-alcoholic fatty liver disease (NAFLD) is a progressive metabolic liver disorder characterized by excessive fat accumulation in the liver unrelated to alcohol consumption. It arises primarily from obesity, insulin resistance, dyslipidemia, and sedentary lifestyles, and can advance to Nonalcoholic Steatohepatitis (NASH), fibrosis, cirrhosis, and hepatocellular carcinoma. As the condition progresses silently, many patients remain undiagnosed until significant liver damage has occurred.

The NAFLD treatment landscape is rapidly evolving, with therapies focused on improving metabolic function, reducing liver fat, and slowing or reversing fibrosis. Drug classes under investigation include thyroid hormone receptor-β agonists, GLP-1 receptor agonists, FGF analogues, anti-fibrotic agents, and metabolic modulators. In March 2024, Rezdiffra (resmetirom) became the first FDA-approved therapy for NASH with moderate to advanced fibrosis. This once-daily oral THR-β agonist demonstrated significant improvement in liver inflammation and fibrosis markers, marking a major milestone for the NAFLD/NASH drug pipeline and paving the way for expanded therapeutic innovation.

Non Alcoholic Fatty Liver Disease (NAFLD) Epidemiology

The NAFLD pipeline continues to grow in response to its rising global burden. According to 2021 data, adults aged 15–49 years experienced an incidence rate of 909.48 per 100,000 persons and a prevalence of 16,580.43 per 100,000 persons, reflecting its expanding impact on younger populations. Mortality reached 0.45 per 100,000 persons, while DALYs were 22.77 per 100,000 person-years, emphasizing the substantial health burden associated with the disease. These trends are closely linked to increasing rates of obesity, type 2 diabetes, and sedentary lifestyles worldwide. With no widely approved targeted therapy for early disease stages, the escalating prevalence underscores an urgent need for continued innovation in metabolic, anti-inflammatory, and anti-fibrotic treatments.

Non Alcoholic Fatty Liver Disease (NAFLD) – Pipeline Therapeutic Assessment

This section of the report covers the analysis of non alcoholic fatty liver disease (NAFLD) drug candidates based on several segmentations, including:

By Phase

The pipeline assessment report covers 50+ drug analyses based on phase:

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

The non alcoholic fatty liver disease (NAFLD) pipeline analysis report covers 50+ drug analyses based on drug classes:

  • Small molecule
  • Monoclonal antibody
  • Peptide
  • Polymer
  • Gene therapy

By Route of Administration

The pipeline assessment report covers 50+ drug analyses based on the route of administration:

  • Oral
  • Intravenous
  • Subcutaneous
  • Parenteral
  • Topical

Non Alcoholic Fatty Liver Disease (NAFLD) Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II, with 22%, covers a major share of the total non alcoholic fatty liver disease (NAFLD) clinical trials. It is followed by phase I at 9%, and others. Strong representation across all phases indicates a robust pipeline, fostering innovation and potential new therapies that can enhance treatment options and market growth.

Non Alcoholic Fatty Liver Disease (NAFLD) Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the non alcoholic fatty liver disease (NAFLD) pipeline analysis include small molecules, polymers, peptides, gene therapy, and monoclonal antibody. The non alcoholic fatty liver disease (NAFLD) report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for non alcoholic fatty liver disease. For example, Semaglutide, a GLP-1 receptor agonist and peptide-based drug, is a prominent candidate under investigation for NAFLD and NASH. It works by enhancing insulin sensitivity, promoting weight loss, and reducing hepatic fat accumulation, which are key drivers of disease progression. Ongoing Phase 2 and Phase 3 studies are evaluating its potential to improve liver histology and metabolic outcomes while maintaining an established safety profile from its approved uses in diabetes and obesity.

Non Alcoholic Fatty Liver Disease (NAFLD) Clinical Trials – Key Players

The EMR report for the non alcoholic fatty liver disease (NAFLD) pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed non alcoholic fatty liver disease (NAFLD) therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in non alcoholic fatty liver disease (NAFLD) clinical trials:

  • Madrigal Pharmaceuticals, Inc.
  • Ain Shams University
  • The University of Texas Health Science Center
  • Akero Therapeutics, Inc.
  • Novo Nordisk A/S
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • GlaxoSmithKline
  • Hepion Pharmaceuticals, Inc.
  • Tasly Biopharmaceuticals Co., Ltd.
  • 1Globe Health Institute
  • Seoul National University Hospital
  • Boehringer Ingelheim

Non Alcoholic Fatty Liver Disease (NAFLD) – Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for non alcoholic fatty liver disease (NAFLD). It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of non alcoholic fatty liver disease (NAFLD) drug candidates.

Drug: Resmetirom

Resmetirom, developed by Madrigal Pharmaceuticals, Inc., is being evaluated in a Phase 3 open-label extension study for patients with non-alcoholic fatty liver disease. This investigational thyroid hormone receptor-β agonist is designed to reduce liver fat and improve metabolic and fibrotic biomarkers. The MAESTRO-NAFLD-OLE study aims to assess long-term safety, tolerability, and biomarker response in participants previously enrolled in the MAESTRO program. As an interventional trial, it focuses on sustained therapeutic effects without a comparator arm. The study is active but not recruiting and is expected to be completed between March and April 2026.

Drug: Semaglutide

Semaglutide, evaluated by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) with support from the National Cancer Institute (NCI), is being studied in a Phase 2 interventional trial for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). This GLP-1 receptor agonist is designed to enhance metabolic regulation, reduce hepatic fat, and improve glucose responses. The NAFLD HEROES study aims to assess semaglutide’s effects on liver function, glucose tolerance, and related biomarkers. Currently recruiting participants, the trial will measure both safety and metabolic outcomes, with completion expected between August and October 2026.

Drug: B1344

B1344, developed by Tasly Biopharmaceuticals Co., Ltd., is being investigated in a Phase 1 interventional study for patients with non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). This early-stage trial aims to evaluate the safety, tolerability, and pharmacokinetics of multiple subcutaneous injections of B1344 compared with placebo. As a first-in-human assessment, the study focuses on determining dose-related responses and establishing a foundational safety profile before advancing to later phases. The trial is currently recruiting participants, with expected completion between June and July 2026.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Key Questions Answered in the Non Alcoholic Fatty Liver Disease (NAFLD) Pipeline Insight Report

  • Which companies/institutions are leading the non alcoholic fatty liver disease (NAFLD) drug development?
  • What is the efficacy and safety profile of non alcoholic fatty liver disease (NAFLD) pipeline drugs?
  • Which company is leading the non alcoholic fatty liver disease (NAFLD) pipeline development activities?
  • What is the current non alcoholic fatty liver disease (NAFLD) commercial assessment?
  • What are the opportunities and challenges present in the non alcoholic fatty liver disease (NAFLD) pipeline landscape?
  • What is the efficacy and safety profile of non alcoholic fatty liver disease (NAFLD) pipeline drugs?
  • Which company is conducting major trials for non alcoholic fatty liver disease (NAFLD) drugs?
  • Which companies/institutions are involved in non alcoholic fatty liver disease (NAFLD) collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in non alcoholic fatty liver disease (NAFLD)?

Reasons To Buy This Report

The Non Alcoholic Fatty Liver Disease (NAFLD) Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for non alcoholic fatty liver disease (NAFLD). It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into non alcoholic fatty liver disease (NAFLD) collaborations, regulatory environments, and potential growth opportunities.

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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Small molecule
  • Monoclonal antibody
  • Peptide
  • Polymer
  • Gene therapy

Leading Sponsors Covered

  • Madrigal Pharmaceuticals, Inc.
  • Ain Shams University
  • The University of Texas Health Science Center
  • Akero Therapeutics, Inc.
  • Novo Nordisk A/S
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • GlaxoSmithKline
  • Hepion Pharmaceuticals, Inc.
  • Tasly Biopharmaceuticals Co., Ltd.
  • 1Globe Health Institute
  • Seoul National University Hospital
  • Boehringer Ingelheim

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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