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Nonalcoholic Steatohepatitis - Pipeline Insight, 2021

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Date: 31-May-2021
No. of pages: 230
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DelveInsight's, "Nonalcoholic Steatohepatitis - Pipeline Insight, 2021," report provides comprehensive insights about 140+ companies and 140+ pipeline drugs in Nonalcoholic Steatohepatitis 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 Understanding

Nonalcoholic Steatohepatitis: Overview

Nonalcoholic steatohepatitis (NASH) is liver inflammation and damage caused by a fat buildup in the liver. It is part of a group of conditions called nonalcoholic fatty liver disease. Nonalcoholic fatty liver disease can be divided into the isolated fatty liver in which there is only accumulation of fat, and nonalcoholic steatohepatitis (NASH), in which there is fat, inflammation, and damage to liver cells. In NASH, there is an abnormal amount of fat in the liver cells, but, in addition, in NASH, there is inflammation within the liver, and, as a result, the liver cells are damaged, they die, and are replaced by scar tissue. NASH usually does not cause symptoms. Most people who have NASH feel fine and do not know that they have it. As NASH progresses and liver damage gets worse, a patient may start to have symptoms such as Fatigue, Weight loss, General weakness, and acne in the upper right part of the belly.

"Nonalcoholic Steatohepatitis - 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 pipeline landscape is provided which includes the disease overview and Nonalcoholic Steatohepatitis treatment guidelines. The assessment part of the report embraces, in depth Nonalcoholic Steatohepatitis 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 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 R&D. The therapies under development are focused on novel approaches to treat/improve Nonalcoholic Steatohepatitis.

Nonalcoholic Steatohepatitis Emerging Drugs Chapters

This segment of the Nonalcoholic Steatohepatitis 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 Emerging Drugs

- Semaglutide: Novo Nordisk

Semaglutide is a long-acting GLP-1 analog intended as a once-daily treatment for Nonalcoholic fatty liver disease (NASH). It is currently in the phase III stage of development for NASH and is being developed by Novo Nordisk.

- Resmetirom: Madrigal Pharmaceuticals

Resmetirom (MGL-3196) is a first-in-class, orally-administered, small-molecule, liver-directed thyroid hormone receptor (THR) ?-selective agonist. Preclinical, toxicology, Phase 1, and Phase 2 clinical data suggest resmetirom has an attractive, differentiated profile as a potential treatment for Nonalcoholic steatohepatitis (NASH), Nonalcoholic fatty liver disease (NAFLD) and associated dyslipidemias. THR-? selectivity also enhances the safety profile of resmetirom, compared to non-selective agents. Resmetirom has shown neither suppression of the central thyroid axis nor THR-? effects on heart rate or bone, reducing elevated liver enzymes in NASH patients. It is currently in the Phase III stage of development for Nonalcoholic steatohepatitis and is being developed by Madrigal Pharmaceuticals.

- Oltipraz: PharmaKing

Oltipraz is currently in the Phase III stage of development for nonalcoholic steatohepatitis (NASH). It is being developed by Pharmaking and acts as Glutathione transferase stimulants, Liver X receptor antagonists, NQO1 stimulants, and Ribosomal protein S6 kinase modulators.

- ALS-L1023: AngioLab

ALS L1023 is a dried extract of ethyl acetate, prepared by activity-guided fractionation from Melissa leaf (lemon balm). The Angiogenesis Inhibitor ALS-L1023 from Lemon-Balm Leaves Attenuates High-Fat Diet-Induced Nonalcoholic Fatty Liver Disease through Regulating the Visceral Adipose-Tissue Function. The drug is currently being investigated in Phase II clinical trials for the treatment of patients with Nonalcoholic Steatohepatitis.

- ORMD-0801: Oramed

Oramed's oral insulin (ORMD-0801) has the potential to create a new paradigm in the treatment of diabetes and Nonalcoholic Steatohepatitis by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or even eliminating late-stage complications. A Phase II clinical trial is currently being evaluated for ORMD-801 in the patients with Nonalcoholic Steatohepatitis.

- CB4211: CohBar

CB4211 is our novel, refined analog of MOTS-c, a naturally occurring mitochondrial peptide. MOTS-c plays a significant role in the regulation of metabolism. CB4211 also inhibits adipocyte lipolysis, a process that is foundational in the development of liver steatosis, through an insulin-dependent mechanism. The drug is being developed and investigated by CohBar in Phase I for the treatment of Nonalcoholic Steatohepatitis.

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

Nonalcoholic Steatohepatitis: Therapeutic Assessment

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

- Major Players in Nonalcoholic Steatohepatitis

There are approx. 140+ key companies which are developing the therapies for Nonalcoholic Steatohepatitis. The companies which have their Nonalcoholic Steatohepatitis drug candidates in the most advanced stage, i.e. phase III include, Madrigal Pharmaceuticals.

- Phases

DelveInsight's report covers around 140+ 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 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

- Parenteral

- Intravenous

- Subcutaneous

- Topical

- Molecule Type

Products have been categorized under various Molecule types such as

- Monoclonal Antibody

- Peptides

- Hepatoprotectant

- Small molecule

- Cell therapy

- Antisense oligonucleotides

- Recombinant proteins

- Small interfering RNA

- Product Type

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

Nonalcoholic Steatohepatitis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Nonalcoholic Steatohepatitis 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 drugs.

Nonalcoholic Steatohepatitis Report Insights

- Nonalcoholic Steatohepatitis Pipeline Analysis

- Therapeutic Assessment

- Unmet Needs

- Impact of Drugs

Nonalcoholic Steatohepatitis 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 drugs?

- How many Nonalcoholic Steatohepatitis 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?

- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Nonalcoholic Steatohepatitis 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 and their status?

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

Key Players

- Novo Nordisk

- Madrigal Pharmaceuticals

- PharmaKing

- Cirius Therapeutics

- Inventiva Pharma

- Galmed Pharmaceuticals

- AbbVie

- Galectin Therapeutics

- Viking Therapeutics

- Sagimet Biosciences

- Novartis

- Hepion Pharmaceuticals

- Celgene

- Boston Pharmaceuticals

- Bristol-Myers Squibb

- NGM Biopharmaceuticals

- Boehringer Ingelheim

- Axcella Health

- Corcept Therapeutics

- TaiwanJ Pharmaceuticals

- AngioLab

- Oramed

- Can-Fite Biopharma

- Mitsubishi Tanabe Pharma

- MediciNova

- Merck Sharp & Dohme

- Metacrine

- MedImmune

- Lipocine

- Chemomab Therapeutics

- Afimmune

- NorthSea Therapeutics

- Rivus Pharmaceuticals

- HighTide Biopharma

- Hanmi Pharmaceutical

- ENYO Pharma

- Histogen

- Akero Therapeutics

- Enanta Pharmaceuticals

- Gilead Sciences

- Ionis Pharmaceuticals

- Eli Lilly and Company

- Terns Pharmaceuticals

- Sinew Pharma

- Poxel

- CytoDyn

- Future Medicine

- 89bio Ltd.

- HK inno.N

- Arrowhead Pharmaceuticals

- Promethera Biosciences

- Enanta Pharmaceuticals

Key Products

- Semaglutide

- Resmetirom

- Oltipraz

- MSDC-0602K

- Lanifibranor

- Aramchol

- Cenicriviroc

- Belapectin

- VK2809

- TVB-2640

- Tropifexor (LJN452)

- CRV431

- CC-90001

- BOS-580

- BMS-986263

- Aldafermin

- BI 456906

- AXA1125

- Miricorilant

- JKB-122

- ALS-L1023

- ORMD-0801

- Namodenoson

- MN-001

- MT-3995

- MK-3655

- MET642

- MEDI 0382

- LYS006

- LPCN 1144

- CM101

- Epeleuton

- Icosabutate

- HU6

- HTD1801

- HM15211

- EPY001a

- Emricasan

- Efruxifermin (EFX)

- EDP-305

- Firsocostat

- ION224

- Tirzepatide

- TERN-101

- SNP-610

- PXL770

- Leronlimab

- FM101

- BIO89-100

- IN-A010

- ARO-HSD

- HepaStem

- EDP-297

Nonalcoholic Steatohepatitis - Pipeline Insight, 2021

Table of Contents

Introduction
Executive Summary
Nonalcoholic Steatohepatitis: 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 - DelveInsight's Analytical Perspective
In-depth Commercial Assessment
• Nonalcoholic Steatohepatitis companies' collaborations, Licensing, Acquisition -Deal Value Trends
Nonalcoholic Steatohepatitis Collaboration Deals
• Company-Company Collaborations (Licensing / Partnering) Analysis
• Company-University Collaborations (Licensing / Partnering) Analysis
Late Stage Products (Phase III)
• Comparative Analysis
Resmetirom: Madrigal Pharmaceuticals
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
• Comparative Analysis
ALS-L1023: AngioLab
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Early Stage Products (Phase I)
• Comparative Analysis
CB4211: CohBar
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Preclinical and Discovery Stage Products
• Comparative Analysis
ALG-055009: Aligos Therapeutics
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..


Inactive Products
• Comparative Analysis
Nonalcoholic Steatohepatitis Key Companies
Nonalcoholic Steatohepatitis Key Products
Nonalcoholic Steatohepatitis- Unmet Needs
Nonalcoholic Steatohepatitis- Market Drivers and Barriers
Nonalcoholic Steatohepatitis- Future Perspectives and Conclusion
Nonalcoholic Steatohepatitis Analyst Views
Nonalcoholic Steatohepatitis Key Companies
Appendix


List of Tables

Table 1 Total Products for Nonalcoholic Steatohepatitis
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
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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