Liver Cirrhosis Pipeline, NDA Approval, Emerging Drugs & Companies Report 2023 | Major Companies – Genfit, Novartis, GSK, and Others

April 26 23:00 2023
Liver Cirrhosis Pipeline, NDA Approval, Emerging Drugs & Companies Report 2023 | Major Companies - Genfit, Novartis, GSK, and Others

DelveInsight’s, “Liver Cirrhosis Pipeline Insight 2023” report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Liver Cirrhosis pipeline landscape. It covers the Liver Cirrhosis pipeline drug profiles, including Liver Cirrhosis clinical trials and nonclinical stage products. It also covers the Liver Cirrhosis therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

 

Key Takeaways from the Liver Cirrhosis Pipeline Report

 

  • DelveInsight’s Liver Cirrhosis pipeline report depicts a robust space with 50+ active players working to develop 50+ pipeline therapies for Liver Cirrhosis treatment.

 

  • The leading Liver Cirrhosis Companies includes CymaBay Therapeutics, Mirum Pharmaceuticals, Pharmicell Co., Ltd., Can-Fite BioPharma, Genfit, SHIONOGI & Co., COUR Pharmaceutical, Zydus Therapeutics Inc, Genkyotex SA, Gannex Pharma Co., Ltd., Novartis, HighTide Biopharma Pty Ltd, Chia Tai Tianqing Pharmaceutical Group Co.Ltd., GlaxoSmithKline, Ohara Pharmaceutical, Pliant Therapeutics, MYR Pharmaceuticals, Active Biotech, Future Medicine Co Ltd., Dr. Falk Pharma GmbH, Suzhou Zelgen Biopharmaceuticals, and others.

 

  • Promising Liver Cirrhosis Pipeline Therapies includes IDN-6556, ADSCs, NGM282, Rifaximin SSD 40 mg IR tablet, Livercellgram, INT-747, Obeticholic Acid (OCA), and others.

 

  • The Liver Cirrhosis Companies and academics that are working to assess challenges and seek opportunities that could influence Liver Cirrhosis R&D. The Liver Cirrhosis pipeline therapies under development are focused on novel approaches to treat/improve the disease condition.

 

To explore more information on the latest breakthroughs in the Liver Cirrhosis Pipeline treatment landscape of the report, click here @ Liver Cirrhosis Pipeline Outlook

 

Liver Cirrhosis Overview

Liver cirrhosis refers to a shrunken, scarred and hardened liver with potential for deterioration of liver function. It results from chronic (long-term) damage to the liver from various causes, leading to progressive scarring of the liver over years. Liver cirrhosis is a serious condition because once the liver becomes cirrhotic, the damage to the liver is irreversible.

 

Recent Developmental Activities in the Liver Cirrhosis Treatment Landscape

 

  • In January 2023, CymaBay Therapeutics announced that it had entered into a collaboration and license agreementwith Kaken Pharmaceutical for the development and commercialization in Japan of CymaBay’s investigational drugseladelpar for the treatment of primary biliary cholangitis.

 

  • In February 2019, the Food and Drug Administration (FDA) granted Breakthrough Therapy designation to seladelparfor the treatment of early-stage primary biliary cholangitis (PBC). In September 2017, CymaBay Therapeutics announced that the European Medicines Agency’s (EMA) Committee forOrphan Medicinal Products (COMP) issued a positive opinion on the application for orphan drug designation ofseladelpar for the treatment of primary biliary cholangitis. The FDA also granted orphan drug designation to seladelparfor the treatment of primary biliary cholangitis.

 

  • Seladelpar is uniquely suited as a potential treatment for inflammatory liver diseases. In the liver, PPARδ is expressed inmultiple cell types, including hepatocytes, cholangiocytes, Kupffer cells, and stellate cells. Preclinical and clinical datasupport its effect on regulating genes involved in bile acids synthesis, inflammation, fibrosis and lipid metabolism, storage,and transport. Currently, the drug is in the Phase III stage of its development for the treatment of Liver Cirrhosis.

 

  • In October 2018, CymaBay Therapeutics initiated a 52-week, placebo-controlled, randomized, Phase III studyto evaluate the safety and efficacy of Seladelpar in subjects with Primary Biliary Cholangitis (PBC) and an inadequateresponse to or an intolerance to Ursodeoxycholic Acid (UDCA). The primary endpoint was to evaluate the percentage ofparticipants with response to composite endpoint of ALP.

 

  • In December 2017, CymaBay Therapeutics initiated an open label long-term study to evaluate the safety andtolerability of Seladelpar in subjects with Primary Biliary Cholangitis (PBC). The primary endpoint is to evaluate thetreatment’s emergent adverse events. The secondary endpoints are to evaluate liver transplantation, change in MELD, andothers. The trial is currently recruiting participants and is expected to be completed by December 2024, with an estimatedenrolment of 500 participants. 

 

  • In November 2016, CymaBay Therapeutics initiated an 8-week, dose ranging, open label, randomized, PhaseII study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary BiliaryCholangitis (PBC) and an inadequate response to or intolerance to Ursodeoxycholic Acid (UDCA). The primary endpoint wasto evaluate the relative change from baseline in serum alkaline phosphatase at Week 8. The secondary endpoints were toevaluate the absolute change from baseline in serum alkaline phosphatase at Week 12 and Week 52, the change inAspartate Aminotransferase (AST) from baseline to 12 Weeks and 52 Weeks, and others. The trial enrolled 119 participantsand was completed in September 2018.

 

For further information, refer to the detailed Liver Cirrhosis Unmet Needs, Liver Cirrhosis Market Drivers, and Liver Cirrhosis Market Barriers, click here for Liver Cirrhosis Ongoing Clinical Trial Analysis

 

Liver Cirrhosis Emerging Drugs Profile

 

  • Seladelpar: CymaBay Therapeutics

Seladelpar (MBX-8025) is a potent, selective, orally active peroxisome proliferator-activated receptor δ (PPARδ) agonist in development for the treatment of patients with the autoimmune liver disease, primary biliary cholangitis (PBC). It has received Breakthrough Therapy Designation (FDA) and PRIME status (EMEA); Orphan Drug Designation in U.S. and Europe. Backed by an extensive body of clinical evidence and global patient experience through its Phase 2 and Phase 3 (ENHANCE) studies of seladelpar in Primary Biliary Cholangitis (PBC)

 

  • Volixibat: Mirum Pharmaceuticals

Volixibat is a minimally absorbed, orally administered investigational therapy designed to selectively inhibit ileal bile acid transporter (IBAT), a protein that is primarily responsible for recycling bile acids from the intestine to the liver. We believe that volixibat may offer a novel approach in the treatment of rare liver diseases impacting both adults and children by blocking the recycling of bile acids, thereby reducing bile acids systemically. Volixibat is currently being studied in intrahepatic cholestasis of pregnancy, primary sclerosing cholangitis, and primary biliary cholangitis.

 

Liver Cirrhosis Pipeline Therapeutics Assessment

There are approx. 50+ key companies which are developing the therapies for Liver Cirrhosis. The companies which have their Liver Cirrhosis drug candidates in the most advanced stage, i.e. phase III include, CymaBay Therapeutics.

 

Request a sample and discover the recent advances in Liver Cirrhosis Ongoing Clinical Trial Analysis and Medications, click here @ Liver Cirrhosis Treatment Landscape

 

Scope of the Liver Cirrhosis Pipeline Insight Report

 

  • Coverage- Global

 

  • Liver Cirrhosis Companies- CymaBay Therapeutics, Mirum Pharmaceuticals, Pharmicell Co., Ltd., Can-Fite BioPharma, Genfit, SHIONOGI & Co., COUR Pharmaceutical, Zydus Therapeutics Inc, Genkyotex SA, Gannex Pharma Co., Ltd., Novartis, HighTide Biopharma Pty Ltd, Chia Tai Tianqing Pharmaceutical Group Co.Ltd., GlaxoSmithKline, Ohara Pharmaceutical, Pliant Therapeutics, MYR Pharmaceuticals, Active Biotech, Future Medicine Co Ltd., Dr. Falk Pharma GmbH, Suzhou Zelgen Biopharmaceuticals, and others.

 

  • Liver Cirrhosis Pipeline Therapies- IDN-6556, ADSCs, NGM282, Rifaximin SSD 40 mg IR tablet, Livercellgram, INT-747, Obeticholic Acid (OCA), and others.

 

  • Liver Cirrhosis Pipeline Segmentation: Product Type, Molecule Type, Mechanism of Action, Route of Administration

  

Dive deep into rich insights for drugs for Liver Cirrhosis Market Drivers and Liver Cirrhosis Market Barriers, click here @ Liver Cirrhosis Unmet Needs and Analyst Views

 

Table of Content 

  1. Introduction
  2. Executive Summary
  3. Liver Cirrhosis: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Liver Cirrhosis – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Seladelpar: CymaBay Therapeutics
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. AV 1142742: Active Biotech
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I/II)
  14. ADR-001: Rohto Pharmaceutical
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. ZG 5216: Suzhou Zelgen Biopharmaceuticals
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Liver Cirrhosis Key Companies
  21. Liver Cirrhosis Key Products
  22. Liver Cirrhosis- Unmet Needs
  23. Liver Cirrhosis- Market Drivers and Barriers
  24. Liver Cirrhosis- Future Perspectives and Conclusion
  25. Liver Cirrhosis Analyst Views
  26. Liver Cirrhosis Key Companies
  27. Appendix

 

Got Queries? Find out the related information on Liver Cirrhosis Mergers and acquisitions, Liver Cirrhosis Licensing Activities @ Liver Cirrhosis Emerging Drugs, and Recent Trends

 

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