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Nonalcoholic steatohepatitis (NASH) - Pipeline Insight, 2021

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Date: 15-Mar-2021
No. of pages: 240
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DelveInsight's, "Nonalcoholic steatohepatitis (NASH) - Pipeline Insight, 2021," report provides comprehensive insights about 150+ companies and 150+ pipeline drugs in Nonalcoholic steatohepatitis (NASH) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

- Global coverage

Nonalcoholic steatohepatitis (NASH) Understanding

Nonalcoholic steatohepatitis (NASH): Overview

Non-Alcoholic Steatohepatitis, liver inflammation and damage caused by a buildup of fat in the liver. Nonalcoholic fatty liver disease (NAFLD) is an umbrella term for a range of liver conditions. The more severe form of NAFLD is called nonalcoholic steatohepatitis (NASH). NASH causes the liver to swell and become damaged. When the buildup of fat causes inflammation and damage this can lead to the scarring of the liver. The main complication of NAFLD and NASH is cirrhosis, which is late-stage scarring in the liver. Cirrhosis occurs in response to liver injury, such as the inflammation in NASH. There is no standard treatment for patients NASH, lifestyle changes have been shown to affect its progression. This may include losing weight, maintaining a healthy diet, or addressing underlying conditions such as hypothyroidism and diabetes.

"Nonalcoholic steatohepatitis (NASH) - Pipeline Insight, 2021" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Nonalcoholic steatohepatitis (NASH) pipeline landscape is provided which includes the disease overview and Nonalcoholic steatohepatitis (NASH) treatment guidelines. The assessment part of the report embraces, in depth Nonalcoholic steatohepatitis (NASH) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Nonalcoholic steatohepatitis (NASH) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

- The companies and academics are working to assess challenges and seek opportunities that could influence Nonalcoholic steatohepatitis (NASH) R&D. The therapies under development are focused on novel approaches to treat/improve Nonalcoholic steatohepatitis (NASH).

Nonalcoholic steatohepatitis (NASH) Emerging Drugs Chapters

This segment of the Nonalcoholic steatohepatitis (NASH) report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Nonalcoholic steatohepatitis (NASH) Emerging Drugs

- Oltipraz: Pharmaking

Oltipraz is a synthetic dithiolethione with potential chemopreventive and anti-angiogenic properties. Oltipraz induces phase II detoxification enzymes, such as glutathione S transferase (GST) and NAD(P)H:quinone oxidoreductase 1 (NQO1). The induction of detoxification enzymes enhances the detoxification of certain cancer-causing agents, thereby enhancing their elimination and preventing carcinogen-induced DNA damages. The drug is in phase III clinical trials for the treatment of NASH.

- MGL-3196: Madrigal Pharmaceuticals

Resmetirom (MGL-3196) is a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR) ?-selective agonist. THR-? selectivity enhances the safety profile of resmetirom, compared to non-selective agents. Resmetirom neither suppresses the central thyroid axis nor THR-? effects on heart rate or bone, and it reduces elevated liver enzymes in NASH patients. Madrigal Pharmaceuticals plans to submit marketing approval application in Non-alcoholic steatohepatitis to the US FDA.

- Aramchol: Galmed Pharmaceuticals

Aramcho (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate. Aramcho is a first in class, orally active, liver targeted SCD - 1 modulator with a dual mode of action on liver fibrosis, down regulation of steatosis and a direct effect on Hepatic Stellate Cells (HSC's), the human collagen producing cells. The drug is currently being studied in phase III stage of development for NASH.

- TERN-101: Terns Pharmaceuticals

TERN-101 is currently being evaluated in phase II clinical trial in patients diagnosed with NASH. TERN-101 is a liver-distributed, non-bile acid FXR agonist. FXR is a nuclear receptor primarily expressed in the liver, intestine and kidneys. FXR regulates hepatic expression of various genes involved in lipid metabolism, inflammation and fibrosis.

- EYP001: ENYO Pharma

EYP001 which is an orally bioavailable synthetic non-steroidal, non-bile acid FXR agonist small molecule developed for the treatment of patients with NASH. The drug is being studied in phase II stage of development.

- EDP 297: Enanta Pharmaceuticals

EDP-297 represents a class of FXR agonists that has been designed to take advantage of increased binding interactions with the receptor. EDP-297 demonstrate potent anti-fibrotic, anti-inflammatory and hepatoprotective effects. Currently the drug is being evaluated in phase I clinical trials for NASH.

Further product details are provided in the report……..

Nonalcoholic steatohepatitis (NASH): Therapeutic Assessment

This segment of the report provides insights about the different Nonalcoholic steatohepatitis (NASH) drugs segregated based on following parameters that define the scope of the report, such as:

- Major Players in Nonalcoholic steatohepatitis (NASH)

There are approx. 5+ key companies which are developing the therapies for Nonalcoholic steatohepatitis (NASH). The companies which have their Nonalcoholic steatohepatitis (NASH) drug candidates in the most advanced stage, i.e. phase III include, Orbus Therapeutics, Inc.

- Phases

DelveInsight's report covers around 5+ products under different phases of clinical development like

- Late stage products (Phase III)

- Mid-stage products (Phase II)

- Early-stage product (Phase I) along with the details of

- Pre-clinical and Discovery stage candidates

- Discontinued & Inactive candidates

- Route of Administration

Nonalcoholic steatohepatitis (NASH) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

- Oral

- Subcutaneous

- Intravenous

- Intramuscular

- Molecule Type

Products have been categorized under various Molecule types such as

- Bispecific Antibody

- Peptides

- Small molecule

- Gene therapy

- Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Nonalcoholic steatohepatitis (NASH): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Nonalcoholic steatohepatitis (NASH) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Nonalcoholic steatohepatitis (NASH) drugs.

Nonalcoholic steatohepatitis (NASH) Report Insights

- Nonalcoholic steatohepatitis (NASH) Pipeline Analysis

- Therapeutic Assessment

- Unmet Needs

- Impact of Drugs

Nonalcoholic steatohepatitis (NASH) Report Assessment

- Pipeline Product Profiles

- Therapeutic Assessment

- Pipeline Assessment

- Inactive drugs assessment

- Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

- How many companies are developing Nonalcoholic steatohepatitis (NASH) drugs?

- How many Nonalcoholic steatohepatitis (NASH) drugs are developed by each company?

- How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Nonalcoholic steatohepatitis (NASH)?

- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Nonalcoholic steatohepatitis (NASH) therapeutics?

- What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?

- What are the clinical studies going on for Nonalcoholic steatohepatitis (NASH) and their status?

- What are the key designations that have been granted to the emerging drugs?

Nonalcoholic steatohepatitis (NASH) - Pipeline Insight, 2021

Table of Contents

Introduction
Executive Summary
Nonalcoholic steatohepatitis (NASH): Overview
* Causes
* Mechanism of Action
* Signs and Symptoms
* Diagnosis
* Disease Management
Pipeline Therapeutics
* Comparative Analysis
Therapeutic Assessment
* Assessment by Product Type
* Assessment by Stage and Product Type
* Assessment by Route of Administration
* Assessment by Stage and Route of Administration
* Assessment by Molecule Type
* Assessment by Stage and Molecule Type
Nonalcoholic steatohepatitis (NASH) - DelveInsight's Analytical Perspective
In-depth Commercial Assessment
* Nonalcoholic steatohepatitis (NASH) companies' collaborations, Licensing, Acquisition -Deal Value Trends
Nonalcoholic steatohepatitis (NASH) Collaboration Deals
* Company-Company Collaborations (Licensing / Partnering) Analysis
* Company-University Collaborations (Licensing / Partnering) Analysis
Late Stage Products (Preregistration)
* Comparative Analysis
Oltipraz: Pharmaking
* Product Description
* Research and Development
* Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
* Comparative Analysis
TERN-101: Terns Pharmaceuticals
* Product Description
* Research and Development
* Product Development Activities
Drug profiles in the detailed report…..
Early Stage Products (Phase I)
* Comparative Analysis
EDP 297: Enanta Pharmaceuticals
* Product Description
* Research and Development
* Product Development Activities
Drug profiles in the detailed report…..
Preclinical Stage Products
* Comparative Analysis
Drug Name: Company Name
* Product Description
* Research and Development
* Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
* Comparative Analysis
Nonalcoholic steatohepatitis (NASH) Key Companies
Nonalcoholic steatohepatitis (NASH) Key Products
Nonalcoholic steatohepatitis (NASH)- Unmet Needs
Nonalcoholic steatohepatitis (NASH)- Market Drivers and Barriers
Nonalcoholic steatohepatitis (NASH)- Future Perspectives and Conclusion
Nonalcoholic steatohepatitis (NASH) Analyst Views
Nonalcoholic steatohepatitis (NASH) Key Companies
Appendix

List of Tables

Table 1 Total Products for Nonalcoholic steatohepatitis (NASH)
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products

List of Figures

Figure 1 Total Products for Nonalcoholic steatohepatitis (NASH)
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products
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