Non-Alcoholic Steatohepatitis (NASH) Pipeline Insight, 2020 by Delveinsight

September 11 19:46 2020
Non-Alcoholic Steatohepatitis (NASH) Pipeline Insight, 2020 by Delveinsight

(Albany,US) DelveInsight has launched a new report on Non-Alcoholic Steatohepatitis Pipeline


“Non-Alcoholic Steatohepatitis (NASH) Pipeline Insight, 2020” report by DelveInsight outlays comprehensive insights of present clinical development scenario and growth prospects across the Non-Alcoholic Steatohepatitis (NASH) market. A detailed picture of the Non-Alcoholic Steatohepatitis (NASH) pipeline landscape is provided, which includes the disease overview and Non-Alcoholic Steatohepatitis (NASH) treatment guidelines. The assessment part of the report embraces in-depth Non-Alcoholic Steatohepatitis (NASH) commercial assessment and clinical assessment of the Non-Alcoholic Steatohepatitis (NASH) pipeline products from the pre-clinical developmental phase to the marketed phase. In the report, a detailed description of the drug is proffered including mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Non-Alcoholic Steatohepatitis (NASH) collaborations, licensing, mergers and acquisition, funding, designations, and other product-related details.


Nonalcoholic Steatohepatitis (NASH) is the progressive form of liver injury that carries a risk of progressive fibrosis, cirrhosis, and end-stage liver disease. It is an advanced form of nonalcoholicfatty liver disease (NAFLD), caused by the buildup of fat in the liver. When this buildup causes inflammation and damage, it is known as NASH, which can lead to scarring of the liver. Scarring of the liver is a potentially life-threatening condition called cirrhosis. NASH usually comes under the category of silent diseases that has very few or no symptoms typically because it does not cause any symptoms until it is too late. In the early period, patients did not complain about anything specific. Even with the advancing fibrosis, the disease may not have any specific problems. However, in the later stages, patients may start developing some non-specific symptoms.


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Non-Alcoholic Steatohepatitis Pipeline

Due to the unmet need for an approved therapy for the treatment of NASH, several companies have shifted their focus toward the development of targeted drugs with a novel mechanism of action. Key players in the market of NASH are Genfit, Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Gilead Sciences, Allergan (Tobira Therapeutics), Galmed Pharmaceuticals, Bristol-Myers Squibb, Cirius Therapeutics, Galectin Therapeutics, Immuron, NGM Biopharmaceuticals, Can-Fite BioPharma, Akcea Therapeutics, Oramed Pharmaceuticals, Ascletis, and others. We expect that the launch of emerging therapies will fill the void treatment areas shortly. The targeted therapies will have stronger penetration than the off-label therapies, and the market is expected to reach billions.

Intercept’s Obeticholic Acid (OCA) is expected to grab maximum market share, owing to its development to target all stages of NASH (F1 to F4), and with the increasing demand for therapies to treat the advanced stage of NASH, i.e., cirrhosis, this drug is expected to influence the market size with a higher percentage. However, recently, in June 2020 the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of fibrosis due to NASH. The CRL indicated that, based on the data the FDA has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH. The FDA recommends that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the study should continue.


Emerging therapies included in the report

  • Elafibranor (GFT505): Genfit
  • Obeticholic Acid (OCA, Ocaliva): Intercept Pharmaceuticals
  • Selonsertib (SEL, Formerly GS-4997): Gilead Sciences
  • Cenicriviroc (CVC): Allergan (Tobira Therapeutics)
  • Cilofexor (GS-9674): Gilead Sciences
  • And many others


Non-Alcoholic Steatohepatitis Report Scope

  • The Non-Alcoholic Steatohepatitis (NASH) report provides an overview of therapeutic pipeline activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and MOA type for Non-Alcoholic Steatohepatitis (NASH) across the complete product development cycle, including all clinical and nonclinical stages.
  • It comprises of detailed profiles of Non-Alcoholic Steatohepatitis (NASH) therapeutic products with key coverage of developmental activities, including technology, collaborations, licensing, mergers and acquisition, funding, designations and other product-related details
  • Detailed Non-Alcoholic Steatohepatitis (NASH) research and development progress and trial details, results wherever available, are also included in the pipeline study.
  • Coverage of dormant and discontinued pipeline projects along with the reasons if available across Non-Alcoholic Steatohepatitis (NASH).


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Table of content

1. Report Introduction

2. Non-Alcoholic Steatohepatitis (NASH) 

3. Non-Alcoholic Steatohepatitis (NASH) Current Treatment Patterns

4. Non-Alcoholic Steatohepatitis (NASH) – DelveInsight’s Analytical Perspective

5. Therapeutic Assessment

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

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

8. Early Stage Products (Phase-I)

9. Pre-clinical Products and Discovery Stage Products

10. Inactive Products

11. Dormant Products

12. Non-Alcoholic Steatohepatitis (NASH) Discontinued Products

13. Non-Alcoholic Steatohepatitis (NASH) Product Profiles

14. Non-Alcoholic Steatohepatitis (NASH) Key Companies

15. Non-Alcoholic Steatohepatitis (NASH) Key Products

16. Dormant and Discontinued Products

17. Non-Alcoholic Steatohepatitis (NASH) Unmet Needs

18. Non-Alcoholic Steatohepatitis (NASH) Future Perspectives

19. Non-Alcoholic Steatohepatitis (NASH) Analyst Review  

20. Appendix

21. Report Methodology


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