Non-Alcoholic Steatohepatitis Pipeline Review | Latest FDA, EMA, and PMDA Approvals, Novel and Emerging Therapies, Clinical Trials, and Treatment Outlook | Madrigal, Intercept, Cirius, Novo Nordisk

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 Gmax Biopharm, Lin Biosciences, Viking Therapeutics, Seal Rock Therapeutics, AstraZeneca, Boehringer Ingelheim, Oramed Pharmaceuticals, ENYO Pharma, Terns Pharmaceuticals, NovoNordisk, Madrigal Pharmaceuticals, Inventiva Pharma, and others, are developing therapies for the Non-Alcoholic Steatohepatitis treatment 

• Emerging Non-Alcoholic Steatohepatitis therapies in the different phases of clinical trials are- GMA-107, LBS-009, VK-1430, SRT-015, AZD 2693, BI 456906, ORMD-0801, EYP001, TERN-501, Semaglutide, Resmetirom, Lanifibranor, and others are expected to have a significant impact on the Non-Alcoholic Steatohepatitis market in the coming years.   
• In April 2023, Resmetirom has been given the FDA’s Breakthrough Therapy designation for treating NASH patients with liver fibrosis, according to a statement from Madrigal Pharmaceuticals. The enrollment process for the Phase 3 MAESTRO-NASH biopsy trial’s outcomes component has been completed, the company added in its announcement.
• In March 2023, On HORIZON, a randomised Phase 2b non-alcoholic steatohepatitis (NASH) clinical trial (NCT05583344), PathAI announced its collaboration with GSK (LSE/NYSE: GSK). Participants in the trial with NASH and advanced fibrosis will have their improvements in liver histology with GSK4532990 measured in comparison to placebo. With the use of its AI-based Measurement of NASH Histology (AIM-NASH) tool, PathAI will be responsible for creating, digitising, and analysing liver biopsy slides for examination by a central pathologist1. AIM-NASH measurements will be used in this study as exploratory endpoints.
• In March 2023, ALG-055009, a thyroid receptor-beta (THR-ß) agonist candidate from Aligos Therapeutics, was presented with Phase 1 results at the 15th Paris Hepatology Conference, which will really take place March 27 through March 29, 2023.
• In March 2023, Positive results from DESTINY-1 (Deuterium-stabilized R-pioglitazone [PXL065] Efficacy and Safety Trial In NASH), a 36-week dose-ranging Phase 2 trial, were published in the Journal of Hepatology, according to POXEL SA. PXL065 is a brand-new, proprietary pioglitazone R-stereoisomer with lower PPAR activity but still the same non-genomic pioglitazone effects.
• In January 2023, The FDA has accepted Intercept Pharmaceuticals’ New Drug Application (NDA) for obeticholic acid (OCA), which was submitted in order to obtain accelerated clearance for the treatment of patients with pre-cirrhotic liver fibrosis brought on by nonalcoholic steatohepatitis (NASH).
• In January 2023, Resmetirom, a liver-directed selective thyroid hormone receptor agonist, was tested in the major Phase III MAESTRO-NASH biopsyclinical trial by Madrigal Pharmaceuticals, Inc. At the NASH-TAG Conference, fresh MAESTRO-NASH results are being presented.
• In August 2022, An international, multi-center, double-blind, randomised, and placebo-controlled trial was started by Madrigal Pharmaceuticals with patients who had well-compensated NASH cirrhosis. For the duration of the study and until the required number of Composite Clinical Outcome events are attained, participants will be randomised 3:1 in a blinded manner to receive 80 mg of resmetirom or a matching placebo administered orally once daily in the morning.
• In July 2022, To assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of orally administered TERN-501 as monotherapy and in combination with TERN-101 in noncirrhotic adults with presumed non-alcoholic steatohepatitis (NASH), TERN Therapeutics started a Phase IIa multicenter, randomised, double-blind, placebo-controlled clinical study.
• In January 2021, The company’s IND for TERN-501, a selective thyroid hormone receptor beta, or THR-, agonist with improved metabolic stability and liver distribution, was approved by the US Food and Drug Administration. These features are meant to increase safety and efficacy in NASH patients.

Non-Alcoholic Steatohepatitis Overview

Non-alcoholic steatohepatitis (NASH) is liver damage and inflammation brought on by an accumulation of fat. It belongs to a class of diseases known as nonalcoholic fatty liver disease. Nonalcoholic steatohepatitis (NASH), which includes fat, inflammation, and liver cell destruction, can be distinguished from isolated fatty liver, which simply manifests as fat buildup.

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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 – Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Inventiva, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, 89bio, Inc., Enanta Pharmaceuticals, 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., Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, 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 Non-Alcoholic Steatohepatitis prevalence, emerging Non-Alcoholic Steatohepatitis 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: Gmax Biopharm, Lin Biosciences, Viking Therapeutics, Seal Rock Therapeutics, AstraZeneca, Boehringer Ingelheim, Oramed Pharmaceuticals, ENYO Pharma, Terns Pharmaceuticals, NovoNordisk, Madrigal Pharmaceuticals, Inventiva Pharma, and others
• Key Non-Alcoholic Steatohepatitis Therapies: GMA-107, LBS-009, VK-1430, SRT-015, AZD 2693, BI 456906, ORMD-0801, EYP001, TERN-501, Semaglutide, Resmetirom, Lanifibranor, 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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