Non-Alcoholic Steatohepatitis (NASH) Clinical Trials Analysis, 2024: FDA, EMA, and PMDA Approvals, Therapies, Treatment Market and Companies by DelveInsight | Madrigal, Intercept, Cirius, Novo Nordisk, Inventiva, Galmed, AstraZeneca

(Las Vegas, Nevada, United States) According to DelveInsight's assessment, globally, the Non-Alcoholic Steatohepatitis pipeline consists of over 100 key companies working on developing more than 150 Non-Alcoholic Steatohepatitis treatment therapies. The analysis includes Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments as per DelveInsight's evaluation.

"Non-Alcoholic Steatohepatitis Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Non-Alcoholic Steatohepatitis Market.
The Non-Alcoholic Steatohepatitis Pipeline report provides a comprehensive commercial and clinical evaluation of pipeline products, spanning from the pre-clinical development phase to the market-ready phase. It includes an in-depth description of each drug, covering its mechanism of action, clinical trials, NDA approvals (if applicable), and product development activities. These activities encompass technology, collaborations, mergers and acquisitions, funding, designations, and other relevant product details.

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Some of the key takeaways from the Non-Alcoholic Steatohepatitis Pipeline Report:
• NASH 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 May 2024, Boehringer Ingelheim announced results of a Multicenter, Randomised, Double-blind, Placebo-controlled, 48-week, Phase III Trial to Evaluate the Efficacy and Safety of Survodutide Administered Subcutaneously in Participants With Overweight or Obesity and Presumed or Confirmed Nonalcoholic Steatohepatitis (NASH)
• In May 2024, Corcept Therapeutics announced results of a Phase 1, Open-label, Single-dose, Adaptive Design Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant
• In April 2024, AstraZeneca announced results of a Phase I/II, Randomised, Single-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD9550 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
• In March 2024, NeuroBo Pharmaceuticals Inc announced results of a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed Non-alcoholic Steatohepatitis (NASH)
• 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.

Non-Alcoholic Steatohepatitis Overview
Non-Alcoholic Steatohepatitis (NASH) is a liver condition characterized by inflammation and liver cell damage, resembling alcoholic hepatitis but occurring in individuals who do not consume significant amounts of alcohol. It is a severe form of non-alcoholic fatty liver disease (NAFLD), where excess fat accumulates in the liver.
The exact cause of NASH is not fully understood, but it is closely associated with obesity, insulin resistance, and metabolic syndrome. Over time, NASH can progress to fibrosis, cirrhosis, and even liver failure.
Symptoms of NASH may be nonspecific and include fatigue, abdominal discomfort, and enlarged liver. Diagnosis typically involves imaging tests, blood tests, and sometimes a liver biopsy to confirm the presence of inflammation and fibrosis.
Management of NASH involves lifestyle changes such as weight loss, dietary modifications, regular exercise, and controlling underlying metabolic conditions like diabetes and high cholesterol. There is ongoing research into pharmacological treatments for NASH, but currently, no specific medication is approved for its treatment. Early detection and intervention are crucial to prevent disease progression and complications.

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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 pipeline 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
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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 NASH Pipeline 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 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

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