“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 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.
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 Spetember 2024, Aligos Therapeutics has revealed encouraging topline results from the Phase IIa HERALD clinical trial of ALG-055009, a thyroid hormone receptor beta agonist aimed at treating metabolic-dysfunction-associated steatohepatitis (MASH). This double-blind, randomized, placebo-controlled study included 102 participants diagnosed with presumed MASH and stages I-III liver fibrosis.
In March 2024, Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical firm specializing in innovative therapies for nonalcoholic steatohepatitis (NASH), has disclosed today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Rezdiffra (resmetirom). This approval is for its use alongside diet and exercise in the treatment of adults diagnosed with noncirrhotic NASH with moderate to advanced liver fibrosis (corresponding to stages F2 to F3 fibrosis). The continuation of approval for this indication may be subject to confirmation and delineation of clinical benefits in ongoing confirmatory studies.
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.
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 110+ 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.
Download Sample PDF Report to know more about Non-Alcoholic Steatohepatitis drugs and therapies
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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