Primary Sclerosing Cholangitis - Pipeline Insight, 2024

This “Primary Sclerosing Cholangitis - Pipeline Insight, 2024,” report provides comprehensive insights about 14+ companies and 14+ pipeline drugs in Primary Sclerosing Cholangitis 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

Primary Sclerosing Cholangitis Understanding

Primary Sclerosing Cholangitis: Overview

Primary sclerosing cholangitis (PSC) is a chronic liver disease characterized by a progressive course of cholestasis with inflammation and fibrosis of the intrahepatic and extrahepatic bile ducts. The condition may lead to cirrhosis of the liver with portal hypertension and end-stage liver disease (ESLD). The main symptoms of primary sclerosing cholangitis (PSC) are feeling tired or weak and having itchy skin. Other symptoms may include losing weight without trying, poor appetite, fever, and pain in the abdomen. The cause of PSC is not known. A diagnosis of primary sclerosing cholangitis is made based upon a thorough clinical evaluation, a detailed patient history, identification of characteristic findings, and a variety of specialized tests. Diagnosis is done by cholangiography (magnetic resonance cholangiopancreatography [MRCP] or endoscopic retrograde cholangiopathy [ERCP]). Treatments for primary sclerosing cholangitis focus on managing complications and monitoring liver damage. Endoscopic surgery to remove blockages and enlarge narrowed bile ducts may be of benefit to help prevent liver deterioration in certain cases. Lost vitamins should be replaced when required to prevent complications related to these deficiencies.

Primary Sclerosing Cholangitis - Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Primary Sclerosing Cholangitis pipeline landscape is provided which includes the disease overview and Primary Sclerosing Cholangitis treatment guidelines. The assessment part of the report embraces, in depth Primary Sclerosing Cholangitis 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, Primary Sclerosing Cholangitis 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 Primary Sclerosing Cholangitis R&D. The therapies under development are focused on novel approaches to treat/improve Primary Sclerosing Cholangitis.

Primary Sclerosing Cholangitis Emerging Drugs Chapters

This segment of the Primary Sclerosing Cholangitis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, 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.

Primary Sclerosing Cholangitis Emerging Drugs

GS-9674: Gilead Sciences GS-9674 (Cilofexor) is an orally active, small molecule based nonsteroidal FXR agonist. The drug is in Phase III clinical studies for the treatment of Primary sclerosingcholangitis.

IMU-838: Immunic IMU-838 is a small molecule investigational drug (vidofludimus calcium) under development as an oral tablet formulation for the treatment PSC. The drug is in clinical studies for the treatment of Relapsing-Remitting Multiple Sclerosis, Progressive Multiple Sclerosis, Ulcerative Colitis, Crohn’s Disease, and Primary Sclerosing Cholangitis. The drug is in Phase II clinical studies for the treatment of Primary sclerosingcholangitis.

Primary Sclerosing Cholangitis: Therapeutic Assessment

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

Major Players in Primary Sclerosing Cholangitis

There are approx. 14+ key companies which are developing the therapies for Primary Sclerosing Cholangitis. The companies which have their Primary Sclerosing Cholangitis drug candidates in the most advanced stage, i.e. Phase III include, Gilead Sciences.

Phases

This 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) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

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

Products have been categorized under various Molecule types such as

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

Product Type

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

Primary Sclerosing Cholangitis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase III, II, I, preclinical and discovery stage. It also analyses Primary Sclerosing Cholangitis 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 Primary Sclerosing Cholangitis drugs.

Primary Sclerosing Cholangitis Report Insights

• Primary Sclerosing Cholangitis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Primary Sclerosing Cholangitis 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 Primary Sclerosing Cholangitis drugs?
• How many Primary Sclerosing Cholangitis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Primary Sclerosing Cholangitis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Primary Sclerosing Cholangitis 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 Primary Sclerosing Cholangitis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Gilead Sciences
• Immunic
• Dr Falk Pharma
• Pliant Therapeutics
• CymaBay Therapeutics
• SCOHIA PHARMA
• Albireo Pharma
• Sirnaomics
• Morphic Therapeutic

Key Products

• GS-9674
• IMU-838
• Norucholic acid
• PLN-74809
• PLN-75068
• Seladelpar
• SCO-240
• A-3907
• STP-707
• MORF 627

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