Non-Alcoholic Steatohepatitis Pipeline Drugs Analysis Report (2023 Updates): FDA Approvals, Clinical Trials, Therapies, MOA, ROA by DelveInsight | Novo Nordisk, Inventiva, Galmed Pharma, AstraZeneca

Non-Alcoholic Steatohepatitis Pipeline Drugs Analysis Report (2023 Updates): FDA Approvals, Clinical Trials, Therapies, MOA, ROA by DelveInsight | Novo Nordisk, Inventiva, Galmed Pharma, AstraZeneca
(Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Non-Alcoholic Steatohepatitis pipeline constitutes 100+ key companies continuously working towards developing 150+ Non-Alcoholic Steatohepatitis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Non-Alcoholic Steatohepatitis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.


Non-Alcoholic Steatohepatitis Pipeline Insight, 2023 report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Non-Alcoholic Steatohepatitis Market.


Some of the key takeaways from the Non-Alcoholic Steatohepatitis Pipeline Report:

  • Companies across the globe are diligently working toward developing novel Non-Alcoholic Steatohepatitis treatment therapies with a considerable amount of success over the years. 
  • Non-Alcoholic Steatohepatitis companies working in the treatment market are Oramed Pharmaceuticals, ENYO Pharma, Terns Pharmaceuticals, NovoNordisk, Madrigal Pharmaceuticals, Inventiva Pharma, Gmax Biopharm, Lin Biosciences, Viking Therapeutics, Seal Rock Therapeutics, AstraZeneca, Boehringer Ingelheim, and others, are developing therapies for the Non-Alcoholic Steatohepatitis treatment 
  • Emerging Non-Alcoholic Steatohepatitis therapies in the different phases of clinical trials are- ORMD-0801, EYP001, TERN-501, Semaglutide, Resmetirom, Lanifibranor, GMA-107, LBS-009, VK-1430, SRT-015, AZD 2693, BI 456906, and others are expected to have a significant impact on the Non-Alcoholic Steatohepatitis market in the coming years.
  • In April 2023, Madrigal Pharmaceuticals revealed that resmetirom attained Breakthrough Therapy designation sanctioned by the U.S. Food and Drug Administration (FDA) to treat patients dealing with NASH accompanied by liver fibrosis. Additionally, the company reported the completion of patient enrollment for the outcomes segment of the Phase 3 MAESTRO-NASH biopsy trial.
  • In March 2023, PathAI has announced its collaboration with GSK (LSE/NYSE: GSK) on HORIZON, a randomized Phase 2b clinical trial (NCT05583344) aimed at non-alcoholic steatohepatitis (NASH). This trial aims to assess the liver histology improvements using GSK4532990 versus a placebo in individuals diagnosed with NASH and advanced fibrosis. PathAI will play a role in producing, digitizing, and analyzing liver biopsy slides for central pathologist assessment, along with utilizing its AI-based Measurement of NASH Histology (AIM-NASH) tool for histologic evaluations, which will be included as exploratory endpoints in the study.
  • In March 2023, Aligos Therapeutics showcased Phase 1 findings for ALG-055009, its thyroid receptor-beta (THR-ß) agonist candidate, during the 15th Paris Hepatology Conference held virtually from March 27 to 29, 2023.
  • In March 2023, POXEL SA reported positive findings from DESTINY-1 (Deuterium-stabilized R-pioglitazone [PXL065] Efficacy and Safety Trial In NASH) in the Journal of Hepatology. This 36-week Phase 2 trial showcased PXL065, a unique deuterium-stabilized R-stereoisomer of pioglitazone. This compound exhibits reduced PPARγ activity while preserving non-genomic pioglitazone effects.
  • In January 2023, Intercept Pharmaceuticals disclosed that the U.S. Food and Drug Administration (FDA) has approved Intercept’s New Drug Application (NDA) for obeticholic acid (OCA). This application aims for accelerated approval to treat individuals with pre-cirrhotic liver fibrosis caused by nonalcoholic steatohepatitis (NASH).
  • In January 2023, Madrigal Pharmaceuticals, Inc. revealed further findings from the pivotal Phase III MAESTRO-NASH biopsy clinical trial featuring Resmetirom, a targeted thyroid hormone receptor agonist for the liver. These updated findings from the MAESTRO-NASH trial are being showcased at the NASH-TAG Conference.
  • In August 2022, Madrigal Pharmaceuticals has launched a double-blind, randomized, placebo-controlled multinational study across multiple centers. This study targets individuals with well-compensated NASH cirrhosis, where participants will receive either 80 mg of resmetirom or a matching placebo in a 3:1 randomization, administered orally once daily in the morning until the necessary number of Composite Clinical Outcome events is reached.
  • In July 2022, TERN Therapeutics has commenced a Phase IIa clinical trial, conducted across multiple centers and employing a randomized, double-blind, placebo-controlled design. The study aims to assess the safety, effectiveness, pharmacokinetics, and pharmacodynamics of orally administered TERN-501 both as a standalone treatment and in conjunction with TERN-101 in Noncirrhotic Adults with Presumed Non-Alcoholic Steatohepatitis (NASH).


Non-Alcoholic Steatohepatitis Overview

A buildup of fat in the liver results in inflammation and damage to the liver known as nonalcoholic steatohepatitis (NASH). It belongs to a category of illnesses known as nonalcoholic fatty liver disease. Nonalcoholic steatohepatitis (NASH), which includes fat, inflammation, and liver cell destruction, and isolated fatty liver, which simply accumulates fat, are the two subtypes of nonalcoholic fatty liver disease.


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Emerging Non-Alcoholic Steatohepatitis Drugs Under Different Phases of Clinical Development Include:

  • GMA-107: Gmax Biopharm
  • LBS-009: Lin Biosciences
  • VK-1430: Viking Therapeutics
  • SRT-015: Seal Rock Therapeutics
  • AZD 2693: AstraZeneca
  • BI 456906: Boehringer Ingelheim
  • ORMD-0801: Oramed Pharmaceuticals
  • EYP001: ENYO Pharma
  • TERN-501: Terns Pharmaceuticals
  • Semaglutide: NovoNordisk
  • Resmetirom Madrigal Pharmaceuticals
  • Lanifibranor: Inventiva Pharma


Non-Alcoholic Steatohepatitis Route of Administration

Non-Alcoholic 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 

  • Intra-articular
  • Intraocular
  • Intrathecal
  • Intravenous
  • Ophthalmic
  • Oral
  • Parenteral
  • Subcutaneous
  • Topical
  • Transdermal


Non-Alcoholic Steatohepatitis Molecule Type

Non-Alcoholic Steatohepatitis Products have been categorized under various Molecule types, such as

  • Oligonucleotide
  • Peptide
  • Small molecule


Non-Alcoholic Steatohepatitis Pipeline Therapeutics Assessment

  • Non-Alcoholic Steatohepatitis Assessment by Product Type
  • Non-Alcoholic Steatohepatitis By Stage and Product Type
  • Non-Alcoholic Steatohepatitis Assessment by Route of Administration
  • Non-Alcoholic Steatohepatitis By Stage and Route of Administration
  • Non-Alcoholic Steatohepatitis Assessment by Molecule Type
  • Non-Alcoholic Steatohepatitis by Stage and Molecule Type


DelveInsight’s Non-Alcoholic Steatohepatitis Report covers around 150+ products under different phases of clinical development like

  • Late-stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I)
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
  • Route of Administration


Further Non-Alcoholic Steatohepatitis product details are provided in the report. Download the Non-Alcoholic Steatohepatitis pipeline report to learn more about the emerging Non-Alcoholic Steatohepatitis therapies


Some of the key companies in the Non-Alcoholic Steatohepatitis Therapeutics Market include:

Key companies developing therapies for Non-Alcoholic Steatohepatitis are – Novo Nordisk, Inventiva, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, 89bio, Inc., Eccogene, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Arrowhead Pharma, LG Chem, Redx Pharma, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Aligos Therapeutics, Altimmune, Inc., and others.


Non-Alcoholic Steatohepatitis Pipeline Analysis:

The Non-Alcoholic Steatohepatitis pipeline report provides insights into 

  • The report provides detailed insights about companies that are developing therapies for the treatment of Non-Alcoholic Steatohepatitis with aggregate therapies developed by each company for the same.
  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Non-Alcoholic Steatohepatitis Treatment.
  • Non-Alcoholic Steatohepatitis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Non-Alcoholic Steatohepatitis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. 
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Non-Alcoholic Steatohepatitis market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.


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Non-Alcoholic Steatohepatitis Pipeline Market Drivers

  • Rise in prevalence, emerging treatment therapies of NASH, growing demand for NASH therapeutics are some of the important factors that are fueling the Non-Alcoholic Steatohepatitis Market.


Non-Alcoholic Steatohepatitis Pipeline Market Barriers

  • However, lack of analogs, use of combination therapies, reimbursement issues and other factors are creating obstacles in the Non-Alcoholic Steatohepatitis Market growth.


Scope of Non-Alcoholic Steatohepatitis Pipeline Drug Insight    

  • Coverage: Global
  • Key Non-Alcoholic Steatohepatitis Companies: Oramed Pharmaceuticals, ENYO Pharma, Terns Pharmaceuticals, NovoNordisk, Madrigal Pharmaceuticals, Inventiva Pharma, Gmax Biopharm, Lin Biosciences, Viking Therapeutics, Seal Rock Therapeutics, AstraZeneca, Boehringer Ingelheim, and others
  • Key Non-Alcoholic Steatohepatitis Therapies: ORMD-0801, EYP001, TERN-501, Semaglutide, Resmetirom, Lanifibranor, GMA-107, LBS-009, VK-1430, SRT-015, AZD 2693, BI 456906, and others
  • Non-Alcoholic Steatohepatitis Therapeutic Assessment: Non-Alcoholic Steatohepatitis current marketed and Non-Alcoholic Steatohepatitis emerging therapies
  • Non-Alcoholic Steatohepatitis Market Dynamics: Non-Alcoholic Steatohepatitis market drivers and Non-Alcoholic Steatohepatitis market barriers 


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Table of Contents

1. Non-Alcoholic Steatohepatitis Report Introduction

2. Non-Alcoholic Steatohepatitis Executive Summary

3. Non-Alcoholic Steatohepatitis Overview

4. Non-Alcoholic Steatohepatitis- Analytical Perspective In-depth Commercial Assessment

5. Non-Alcoholic Steatohepatitis Pipeline Therapeutics

6. Non-Alcoholic Steatohepatitis Late Stage Products (Phase II/III)

7. Non-Alcoholic Steatohepatitis Mid Stage Products (Phase II)

8. Non-Alcoholic Steatohepatitis Early Stage Products (Phase I)

9. Non-Alcoholic Steatohepatitis Preclinical Stage Products

10. Non-Alcoholic Steatohepatitis Therapeutics Assessment

11. Non-Alcoholic Steatohepatitis Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Non-Alcoholic Steatohepatitis Key Companies

14. Non-Alcoholic Steatohepatitis Key Products

15. Non-Alcoholic Steatohepatitis Unmet Needs

16 . Non-Alcoholic Steatohepatitis Market Drivers and Barriers

17. Non-Alcoholic Steatohepatitis Future Perspectives and Conclusion

18. Non-Alcoholic Steatohepatitis Analyst Views

19. Appendix

20. About DelveInsight



About DelveInsight


DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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