DelveInsight’s ‘Primary Sclerosing Cholangitis Pipeline Insight 2023‘ report provides comprehensive global coverage of available, marketed, and pipeline Primary Sclerosing Cholangitis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Primary Sclerosing Cholangitis pipeline domain.
For Primary Sclerosing Cholangitis emerging drugs, the Primary Sclerosing Cholangitis pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.
Key Takeaways from the Primary Sclerosing Cholangitis Pipeline Report
- DelveInsight’s Primary Sclerosing Cholangitis Pipeline analysis depicts a robust space with 25+ active players working to develop 25+ pipeline therapies for Primary Sclerosing Cholangitis treatment.
- The leading Primary Sclerosing Cholangitis companies include Gilead Sciences, Immunic, Dr Falk Pharma, Pliant Therapeutics, CymaBay Therapeutics, SCOHIA PHARMA, Albireo Pharma, Sirnaomics, Morphic Therapeutic, Mirum Pharmaceuticals, Chemomab Therapeutics, Cascade Pharmaceuticals, Qing Bile Therapeutics, Engitix, BiomX, COUR Pharmaceutical, Avolynt, Inc., Selecta Biosciences, Gannex Pharma, LISCure Bioscience, Genfit, HighTide Therapeutics, Calliditas Therapeutics, Invea Therapeutics, and others are evaluating their lead assets to improve the Primary Sclerosing Cholangitis treatment landscape.
- Key Primary Sclerosing Cholangitis pipeline therapies in various stages of development include Cilofexor, Volixibat, CM 101, CS0159, QBT-002, PLN-74809, Research programme: anti-fibrotic therapeutics, STP707, CNP-104, AVO-1681, ASC42, Seladelpar, HTD-1801, Setanaxib, SCO-240, and others.
- In April 2022, Gannex Pharma dosed the first patient in Phase II clinical trial of ASC42 to treat patients with primary biliary cholangitis (PBC). Gannex is expected to complete the Phase II trial in 100 patients by the end of 2022. It intends to soon start a Phase III trial in China, the U.S., and the European Union after the completion of the Phase II study in China.
- In February 2022, Siranomics received the “safe to proceed” letter from the US Food and Drug Administration (FDA) for the Company’s investigational new drug (IND) application for STP707, its lead siRNA (small interfering RNA) drug candidate in Primary Sclerosing Cholangiti . The Company anticipates initiating Phase I study in the second quarter of 2022 to evaluate the safety, tolerability, and pharmacokinetics of STP707, administered intravenously in healthy volunteers.
- In January 2022, US FDA granted Fast Track Designation to CNP-104 for the treatment of Primary Biliary Cholangitis. In November 2021, Ironwood Pharmaceuticals signed an Option Agreement to Acquire an Exclusive License with COUR Pharmaceuticals to Develop and Commercialize CNP-104 for the Treatment of Primary Biliary Cholangitis in the US.
- In January 2022, Engitix Builded a Liver Disease Pipeline with €48M Series A round and drug discovery partnership with the Milan-based Dompé Farmaceutici. The proceeds from Engitix’s Series A round will bankroll the development of the company’s tissue models for use in drug discovery. Additionally, the investment will fuel the preclinical development of Engitix’s drug pipeline, with a focus on treating liver diseases including primary sclerosing cholangitis and liver cancer. The first candidate is expected to reach phase I testing by 2025.
Request a sample and discover the recent breakthroughs happening in the Primary Sclerosing Cholangitis pipeline landscape @ Primary Sclerosing Cholangitis Pipeline Outlook
Primary Sclerosing Cholangitis Overview
Primary Sclerosing Cholangitis (PSC) is a chronic, progressive cholestatic liver disorder with an unknown cause. Inflammation, fibrosis, and stricture of intrahepatic and extrahepatic biliary ducts characterize Primary Sclerosing Cholangitis. Primary Sclerosing Cholangitis is frequently a progressive disease that results in cholestasis and liver failure. Primary Sclerosing Cholangitis has three types: classic, small duct, and autoimmune hepatitis. Primary Sclerosing Cholangitis causes are unknown. In people who are genetically predisposed to the disease, the immune system’s response to an infection or toxin may cause the disease. Primary Sclerosing Cholangitis has a life expectancy of about 10 years without a liver transplant.
The most common symptoms of Primary Sclerosing Cholangitis are fatigue and itchy skin. Other symptoms of Primary Sclerosing Cholangitis include weight loss without effort, loss of appetite, fever, and abdominal pain. Cirrhosis and liver failure symptoms may include bloating, bruising, easily bleeding, disorientation, difficulty thinking, memory loss, redness in the palms, and swelling in the legs, ankles, or feet as the disease progresses. The presence of numerous and focused regions of stricturing and dilatation of intrahepatic and extrahepatic bile ducts on cholangiography is commonly used to make the diagnosis of Primary Sclerosing Cholangitis.
The treatment for Primary Sclerosing Cholangitis is difficult and complicated. There is currently no known treatment for Primary Sclerosing Cholangitis. Ursodeoxycholic acid (UDCA) has been extensively studied as a treatment for patients with Primary Sclerosing Cholangitis. The treatment guidelines for Primary Sclerosing Cholangitis are contradictory.
Find out more about Primary Sclerosing Cholangitis medication @ New Drug for Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis Pipeline Analysis: Drug Profile
GS-9674: Gilead Sciences
Ciofexor (GS-9674) is an orally active, nonsteroidal FXR agonist based on small molecules. The drug is currently being studied in Phase III clinical trials for the treatment of primary sclerosing cholangitis.
IMU-838: Immunic
IMU-838 is an investigational small molecule drug (vidofludimus calcium) being developed as an oral tablet formulation for the treatment of PSC. The drug is being tested in clinical trials to treat Relapsing-Remitting Multiple Sclerosis, Progressive Multiple Sclerosis, Ulcerative Colitis, Crohn’s Disease, and Primary Sclerosing Cholangitis. The drug is currently being studied in Phase II clinical trials for the treatment of primary sclerosing cholangitis.
Primary Sclerosing Cholangitis Pipeline Therapies and Key Companies
- Cilofexor: Gilead Sciences
- PLN-74809: Pliant Therapeutics
- Volixibat: Mirum Pharmaceuticals
- CM 101: Chemomab Therapeutics
- CS0159: Cascade Pharmaceuticals
- A-3907: Albireo Pharma
- QBT-002: Qing Bile Therapeutics
- Research programme: anti-fibrotic therapeutics: Engitix
Learn more about the novel and emerging Primary Sclerosing Cholangitis pipeline therapies @ Primary Sclerosing Cholangitis Clinical Trials
Primary Sclerosing Cholangitis Therapeutics Assessment
- By Product Type
- Monotherapy
- Combination Therapy
- By Stage
- Discovery
- Pre-Clinical
- Phase I
- Phase II
- Phase III
- Pre-registration
- By Route of Administration
-
- Oral
- Parenteral
- Topical
- Intravitreal
- Subretinal
- By Molecule Type
- Gene therapy
- Small molecule
- Polymers
- Peptides
- Monoclonal antibodies
Scope of the Primary Sclerosing Cholangitis Pipeline Report
- Coverage: Global
- Key Primary Sclerosing Cholangitis Companies: Gilead Sciences, Immunic, Dr Falk Pharma, Pliant Therapeutics, CymaBay Therapeutics, SCOHIA PHARMA, Albireo Pharma, Sirnaomics, Morphic Therapeutic, Mirum Pharmaceuticals, Chemomab Therapeutics, Cascade Pharmaceuticals, Qing Bile Therapeutics, Engitix, BiomX, COUR Pharmaceutical, Avolynt, Inc., Selecta Biosciences, Gannex Pharma, LISCure Bioscience, Genfit, HighTide Therapeutics, Calliditas Therapeutics, Invea Therapeutics, and others.
- Key Primary Sclerosing Cholangitis Pipeline Therapies: Cilofexor, Volixibat, CM 101, CS0159, QBT-002, PLN-74809, Research programme: anti-fibrotic therapeutics, STP707, CNP-104, AVO-1681, ASC42, Seladelpar, HTD-1801, Setanaxib, SCO-240, and others.
Dive deep into rich insights for drugs used for Primary Sclerosing Cholangitis treatment; visit @ Primary Sclerosing Cholangitis Drugs
Table of Contents
| 1. | Introduction |
| 2. | Executive Summary |
| 3. | Primary Sclerosing Cholangitis Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | Primary Sclerosing Cholangitis Pipeline Therapeutics |
| 6. | Primary Sclerosing Cholangitis Pipeline: Late Stage Products (Phase III) |
| 7. | Primary Sclerosing Cholangitis Pipeline: Late Stage Products (Phase III) |
| 8. | Primary Sclerosing Cholangitis Pipeline: Mid Stage Products (Phase II) |
| 9. | Primary Sclerosing Cholangitis Pipeline: Early Stage Products (Phase I) |
| 10. | Therapeutic Assessment |
| 11. | Inactive Products |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products |
| 15. | Unmet Needs |
| 16. | Market Drivers and Barriers |
| 17. | Future Perspectives and Conclusion |
| 18. | Analyst Views |
| 19. | Appendix |
For further information on the Primary Sclerosing Cholangitis therapy in the pipeline, reach out @ Primary Sclerosing Cholangitis Medication
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