Primary Sclerosing Cholangitis Pipeline Assessment 2024: FDA, EMA, PDMA Approvals, Clinical Trials, Therapies, MOA, ROA and Companies by DelveInsight | GRI-0124, QBT-002, STP707, CS0159, CM 101, more

Primary Sclerosing Cholangitis Pipeline

(Albany, USA) “Primary Sclerosing Cholangitis Pipeline Insight, 2024” report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Primary Sclerosing Cholangitis Market.

The Primary Sclerosing Cholangitis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, FDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

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Some of the key takeaways from the Primary Sclerosing Cholangitis Pipeline Report:

• Primary Sclerosing Cholangitis Companies across the globe are diligently working toward developing novel Primary Sclerosing Cholangitis treatment therapies with a considerable amount of success over the years. 
• Primary Sclerosing Cholangitis companies working in the treatment market are Engitix, GRI Bio, Qing Bile Therapeutics, Sirnaomics, Cascade Pharmaceuticals, Chemomab Therapeutics, Mirum Pharmaceuticals, Pliant Therapeutics, Inc., HighTide Biopharma, Dr. Falk Pharma, Mirum Pharmaceuticals, CymaBay Therapeutics, Ipsen, Genfit, Albireo, and others, are developing therapies for the Primary Sclerosing Cholangitis treatment 

• Emerging Primary Sclerosing Cholangitis therapies in the different phases of clinical trials are- Research programme-antifibrotic therapeutics, GRI-0124, QBT-002, STP707, CS0159, CM 101, Volixibat, PLN-74809 (bexotegrast), HTD1801, Norursodeoxycholic acid, Volixibat, Seladelpar, Elafibranor, A3907, and others are expected to have a significant impact on the Primary Sclerosing Cholangitis market in the coming years.   
• In November 2023, Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical-stage biotech firm dedicated to pioneering treatments for fibro-inflammatory diseases with significant unmet needs, has revealed that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to CM-101 for treating primary sclerosing cholangitis (PSC) in adult patients. PSC is a fibrotic liver ailment associated with risks like liver transplant, cancer, and premature mortality.
• In September 2023, Pliant Therapeutics, Inc. (Nasdaq: PLRX), has announced encouraging findings from the INTEGRIS-PSC Phase 2a clinical trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis. The trial successfully achieved its primary and secondary objectives, indicating favorable tolerance of bexotegrast over a 12-week treatment period, with its plasma levels escalating proportionally to dosage. Furthermore, the trial explored efficacy through endpoints such as alterations in liver fibrosis markers (including Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels), liver biochemistry, and magnetic resonance imaging (MRI) of the liver.
• In March 2023, Pliant Therapeutics, Inc. revealed the initiation of enrollment in a Phase IIa trial of bexotegrast at a dosage of 320 mg administered once daily for a duration ranging from at least 24 weeks to up to 48 weeks. This trial focuses on patients diagnosed with primary sclerosing cholangitis (PSC) following a favorable safety review conducted by an independent Data Safety Monitoring Board (DSMB).

Primary Sclerosing Cholangitis Overview

Primary Sclerosing Cholangitis (PSC) is a chronic liver disease characterized by inflammation and scarring (fibrosis) of the bile ducts inside and outside the liver. This progressive condition obstructs the flow of bile, leading to liver damage and complications such as cirrhosis, liver failure, and an increased risk of bile duct cancer (cholangiocarcinoma). The exact cause of Primary Sclerosing Cholangitis is unknown, but it is believed to involve an abnormal immune system response, possibly triggered by genetic factors or environmental influences. Primary Sclerosing Cholangitis often occurs in association with other autoimmune conditions such as inflammatory bowel disease (IBD), particularly ulcerative colitis. Symptoms of Primary Sclerosing Cholangitis vary but can include fatigue, itching, jaundice (yellowing of the skin and eyes), abdominal pain, and weight loss. Diagnosis typically involves blood tests, imaging studies (such as MRI or ERCP), and liver biopsy to evaluate liver function and assess the extent of bile duct damage. While there is no cure for Primary Sclerosing Cholangitis, treatment aims to manage symptoms, slow disease progression, and prevent complications. This may involve medications to relieve symptoms and reduce inflammation, endoscopic procedures to widen narrowed bile ducts, liver transplantation in advanced cases, and ongoing monitoring to detect and manage complications early.

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Emerging Primary Sclerosing Cholangitis Drugs Under Different Phases of Clinical Development Include:

• Research programme: antifibrotic therapeutics Engitix
• GRI-0124: GRI Bio
• QBT-002: Qing Bile Therapeutics
• STP707: Sirnaomics
• CS0159: Cascade Pharmaceuticals
• CM 101: Chemomab Therapeutics
• Volixibat: Mirum Pharmaceuticals
• PLN-74809 (bexotegrast): Pliant Therapeutics, Inc.
• HTD1801: HighTide Biopharma
• Norursodeoxycholic acid: Dr. Falk Pharma
• Volixibat: Mirum Pharmaceuticals
• Seladelpar: CymaBay Therapeutics
• Elafibranor: Ipsen/Genfit
• A3907: Albireo/IPSEN

Primary Sclerosing Cholangitis Route of Administration

Primary Sclerosing Cholangitis 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
• Intravitreal
• Subretinal
• Topical
• Molecule Type

Primary Sclerosing Cholangitis Molecule Type

Primary Sclerosing Cholangitis Products have been categorized under various Molecule types, such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy
• Product Type

Primary Sclerosing Cholangitis Pipeline Therapeutics Assessment

• Primary Sclerosing Cholangitis Assessment by Product Type
• Primary Sclerosing Cholangitis By Stage and Product Type
• Primary Sclerosing Cholangitis Assessment by Route of Administration
• Primary Sclerosing Cholangitis By Stage and Route of Administration
• Primary Sclerosing Cholangitis Assessment by Molecule Type
• Primary Sclerosing Cholangitis by Stage and Molecule Type

DelveInsight’s Primary Sclerosing Cholangitis Report covers around 14+ products under different phases of clinical development like

• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Primary Sclerosing Cholangitis product details are provided in the report. Download the Primary Sclerosing Cholangitis pipeline report to learn more about the emerging Primary Sclerosing Cholangitis therapies – https://www.delveinsight.com/sample-request/primary-sclerosing-cholangitis-pipeline-insight

Some of the key companies in the Primary Sclerosing Cholangitis Therapeutics Market include:

Key companies developing therapies for Primary Sclerosing Cholangitis are – HighTide Biopharma, Dr. Falk Pharma, Mirum Pharmaceuticals, Pliant Therapeutics, Inc., Chemomab Therapeutics, CymaBay Therapeutics, Genfit, Albireo, IPSEN, and others.

Primary Sclerosing Cholangitis Pipeline Analysis:

The Primary Sclerosing Cholangitis pipeline report provides insights into 

• The report provides detailed insights about companies that are developing therapies for the treatment of Primary Sclerosing Cholangitis with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Primary Sclerosing Cholangitis Treatment.
• Primary Sclerosing Cholangitis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Primary Sclerosing Cholangitis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. 
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Primary Sclerosing Cholangitis market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

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Primary Sclerosing Cholangitis Pipeline Market Drivers

• Increasing prevalence of diseases associated with PSC such as liver cancer and inflammatory bowel disease, a rising number of research studies on PSC are some of the important factors that are fueling the Primary Sclerosing Cholangitis Market.

Primary Sclerosing Cholangitis Pipeline Market Barriers

• However, withdrawal of molecules from late clinical stages, lack of skilled professionals or trained expertise and other factors are creating obstacles in the Primary Sclerosing Cholangitis Market growth.

Scope of Primary Sclerosing Cholangitis Pipeline Drug Insight    

• Coverage: Global
• Key Primary Sclerosing Cholangitis Companies: Engitix, GRI Bio, Qing Bile Therapeutics, Sirnaomics, Cascade Pharmaceuticals, Chemomab Therapeutics, Mirum Pharmaceuticals, Pliant Therapeutics, Inc., HighTide Biopharma, Dr. Falk Pharma, Mirum Pharmaceuticals, CymaBay Therapeutics, Ipsen, Genfit, Albireo, and others
• Key Primary Sclerosing Cholangitis Therapies: Research programme-antifibrotic therapeutics, GRI-0124, QBT-002, STP707, CS0159, CM 101, Volixibat, PLN-74809 (bexotegrast), HTD1801, Norursodeoxycholic acid, Volixibat, Seladelpar, Elafibranor, A3907, and others
• Primary Sclerosing Cholangitis Therapeutic Assessment: Primary Sclerosing Cholangitis current marketed and Primary Sclerosing Cholangitis emerging therapies
• Primary Sclerosing Cholangitis Market Dynamics: Primary Sclerosing Cholangitis market drivers and Primary Sclerosing Cholangitis market barriers 

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Table of Contents

1. Primary Sclerosing Cholangitis Report Introduction

2. Primary Sclerosing Cholangitis Executive Summary

3. Primary Sclerosing Cholangitis Overview

4. Primary Sclerosing Cholangitis- Analytical Perspective In-depth Commercial Assessment

5. Primary Sclerosing Cholangitis Pipeline Therapeutics

6. Primary Sclerosing Cholangitis Late Stage Products (Phase II/III)

7. Primary Sclerosing Cholangitis Mid Stage Products (Phase II)

8. Primary Sclerosing Cholangitis Early Stage Products (Phase I)

9. Primary Sclerosing Cholangitis Preclinical Stage Products

10. Primary Sclerosing Cholangitis Therapeutics Assessment

11. Primary Sclerosing Cholangitis Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Primary Sclerosing Cholangitis Key Companies

14. Primary Sclerosing Cholangitis Key Products

15. Primary Sclerosing Cholangitis Unmet Needs

16 . Primary Sclerosing Cholangitis Market Drivers and Barriers

17. Primary Sclerosing Cholangitis Future Perspectives and Conclusion

18. Primary Sclerosing Cholangitis Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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