New York, USA, March 25, 2024 (GLOBE NEWSWIRE) -- Cirrhosis Clinical Trial Pipeline Insights Featuring 45+ Companies | DelveInsight
The rise in the number of people suffering from cirrhosis can be attributed to rapidly changing lifestyles such as an increase in alcohol consumption and an unbalanced diet. Hence, the rise in the prevalence of the disease is projected to fuel the growth of the global market.
DelveInsight’s 'Cirrhosis Pipeline Insight 2024' report provides comprehensive global coverage of pipeline cirrhosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the cirrhosis pipeline domain.
Key Takeaways from the Cirrhosis Pipeline Report
- DelveInsight’s cirrhosis pipeline report depicts a robust space with 45+ active players working to develop 50+ pipeline therapies for cirrhosis treatment.
- Key cirrhosis companies such as GWOXI Stem Cell Applied Technology, Lipocine, Galectin Therapeutics, Pharmicell Co., Ltd., Zydus Cadila, Genfit, PRISM Pharma Co, Bristol-Myers Squibb, COUR Pharmaceutical Development Company, Inc., HighTide Biopharma, Gannex Pharma Co., Ltd., Alentis Therapeutics, Vir Biotechnology, and others are evaluating new cirrhosis drugs to improve the treatment landscape.
- Promising cirrhosis pipeline therapies such as Belapectin, GXHPC 1, LPCN 1148, Cellgram-LC, Saroglitazar, Elafibranor, OP-724, BMS 986263, CNP-104, HTD 1801, ASC42, ALE.F02, VIR-2218, and others are under different phases of cirrhosis clinical trials.
- In February 2024, CymaBay Therapeutics announced that the US Food and Drug Administration (FDA) had accepted its New Drug Application (NDA) for seladelpar, an investigational treatment for the management of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid. The FDA has granted priority review and set a Prescription Drug User Fee Act (PDUFA) target action date of August 14, 2024, and notified the company that it is not currently planning to hold an advisory committee meeting to discuss the application.
- In February 2024, Gilead Sciences, Inc. and CymaBay Therapeutics, Inc. announced a definitive agreement under which Gilead will acquire CymaBay for USD 32.50 per share in cash or a total equity value of USD 4.3 billion. The addition of CymaBay’s investigational lead product candidate, seladelpar for the treatment of primary biliary cholangitis (PBC) including pruritus, complements Gilead’s existing liver portfolio and aligns with its long-standing commitment to bringing transformational medicines to patients.
- In November 2023, Ipsen and GENFIT announced full results from the pivotal Phase III ELATIVE trial, which are being presented in a late-breaking oral session (Abstract #484, Monday, 13 November at 16.45 EST) at the American Association for the Study of Liver Diseases (AASLD) and simultaneously published in New England Journal of Medicine (NEJM). This trial evaluated the efficacy and safety of investigational elafibranor, an oral, dual PPAR α,δ agonist, as a potential novel class of treatment for patients with the rare, autoimmune cholestatic liver disease, Primary Biliary Cholangitis (PBC).
- In November 2023, Lipocine Inc., a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, announced the results of its Phase II study evaluating LPCN 1148 are being presented at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting 2023, taking place in Boston MA. The results were featured in a late-breaking oral presentation and e-poster by Dr. Arun Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, advisor to Lipocine.
- In May 2023, Intercept Pharmaceuticals announced that the US Food and Drug Administration (FDA) had granted Orphan Drug Designation for the fixed-dose combination of obeticholic acid (OCA) and bezafibrate, a peroxisome proliferator-activated receptor (PPAR) agonist, for the potential treatment of individuals with primary biliary cholangitis (PBC).
- In January 2023, CymaBay Therapeutics, Inc. announced that it had entered into a collaboration and license agreement with Kaken Pharmaceutical Co., Ltd. for the development and commercialization in Japan of CymaBay’s investigational drug seladelpar for the treatment of primary biliary cholangitis (“PBC”).
Request a sample and discover the recent advances in cirrhosis treatment drugs @ Cirrhosis Pipeline Report
The cirrhosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage cirrhosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the cirrhosis clinical trial landscape.
Cirrhosis Overview
Cirrhosis is liver scarring induced by long-term liver injury. The scar tissue obstructs the liver's ability to function correctly. Cirrhosis is often known as end-stage liver disease since it occurs after various stages of liver damage from illnesses such as hepatitis. Cirrhosis can be prevented, however, because the diseases that most usually cause it advance slowly, and measures to prevent and treat them are available. Furthermore, because most incidences of hepatocellular carcinoma (HCC) occur in cirrhotic livers, cirrhosis prevention is also HCC prevention. Cirrhosis can develop as a result of an exogenous/toxic, infectious, toxic/allergic, immunopathological/autoimmune, or vascular event, or as a result of an inborn metabolic mistake.
Cirrhosis is characterized by cutaneous symptoms of liver disease, a hard liver on palpation, and certain risk factors such as metabolic syndrome, excessive alcohol intake, and exposure to hepatotoxic chemicals. Cirrhosis can cause fatigue or weakness, a loss of appetite, weight loss without effort, nausea and vomiting, and minor pain or discomfort in the upper right side of your abdomen. Cirrhosis has no remedy at the moment. However, there are strategies to control the symptoms and associated problems, as well as halt the advancement of the disease. Treating the underlying cause of cirrhosis (for example, using anti-viral medications to treat hepatitis C) helps prevent cirrhosis from worsening.
Find out more about cirrhosis treatment drugs @ Drugs for Cirrhosis Treatment
A snapshot of the Cirrhosis Pipeline Drugs mentioned in the report:
| Drugs | Company | Phase | MoA | RoA |
| Belapectin | Galectin Therapeutics | Phase II/III | Galectin 3 inhibitors | Intravenous |
| GXHPC 1 | GWOXI Stem Cell Applied Technology | Phase II | Cell replacements | Intrahepatic |
| LPCN 1148 | Lipocine | Phase II | Androgen receptor agonists; Testosterone replacements | Oral |
| Berberine ursodeoxycholate | HighTide Biopharma | Phase II | Lipid modulators | Oral |
| PHIN-214 | PharmaIN | Phase I | Vasopressin 1a receptor agonists | Subcutaneous |
Learn more about the emerging cirrhosis pipeline therapies @ Cirrhosis Clinical Trials
Cirrhosis Therapeutics Assessment
The cirrhosis pipeline report proffers an integral view of the cirrhosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.
Scope of the Cirrhosis Pipeline Report
- Coverage: Global
- Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
- Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
- Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal
- Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule
- Therapeutics Assessment By Mechanism of Action: Cell replacements, Androgen receptor agonists, Testosterone replacements, Lipid modulators, Vasopressin 1a receptor agonists, Galectin 3 inhibitors
- Key Cirrhosis Companies: GWOXI Stem Cell Applied Technology, Lipocine, Galectin Therapeutics, Pharmicell Co., Ltd., Zydus Cadila, Genfit, PRISM Pharma Co, Bristol-Myers Squibb, COUR Pharmaceutical Development Company, Inc., HighTide Biopharma, Gannex Pharma Co., Ltd., Alentis Therapeutics, Vir Biotechnology, and others
- Key Cirrhosis Pipeline Therapies: Belapectin, GXHPC 1, LPCN 1148, Cellgram-LC, Saroglitazar, Elafibranor, OP-724, BMS 986263, CNP-104, HTD 1801, ASC42, ALE.F02, VIR-2218, and others
Dive deep into rich insights for new drugs for cirrhosis treatment, visit @ Cirrhosis Drugs
Table of Contents
| 1. | Cirrhosis Pipeline Report Introduction |
| 2. | Cirrhosis Pipeline Report Executive Summary |
| 3. | Cirrhosis Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | Cirrhosis Clinical Trial Therapeutics |
| 6. | Cirrhosis Pipeline: Late-Stage Products (Pre-registration) |
| 7. | Cirrhosis Pipeline: Late-Stage Products (Phase III) |
| 8. | Cirrhosis Pipeline: Mid-Stage Products (Phase II) |
| 9. | Cirrhosis Pipeline: Early-Stage Products (Phase I) |
| 10. | Cirrhosis Pipeline Therapeutics Assessment |
| 11. | Inactive Products in the Cirrhosis Pipeline |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products in the Cirrhosis Pipeline |
| 15. | Unmet Needs |
| 16. | Market Drivers and Barriers |
| 17. | Future Perspectives and Conclusion |
| 18. | Analyst Views |
| 19. | Appendix |
For further information on the cirrhosis pipeline therapeutics, reach out @ Cirrhosis Treatment Drugs
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