Cholestatic Pruritus - Pipeline Insight, 2024

This “Cholestatic Pruritus- Pipeline Insight, 2024,” report provides comprehensive insights about 6+ companies and 6+ pipeline drugs in Cholestatic Pruritus 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

Cholestatic Pruritus Understanding

Cholestatic Pruritus: Overview

Cholestasis is defined as impaired secretion of bile. Pruritus is a complication of cholestasis including that associated with mutations in genes that code for transporters in the hepatocyte and from inflammatory liver diseases. Pruritus is a debilitating symptom reported among 80% to 100% of patients with cholestatic liver disease, including primary biliary cholangitis, primary sclerosing cholangitis, and intrahepatic cholestasis of pregnancy. Cholestatic pruritus is severe. Although there is no primary rash associated with cholestatic pruritus, patients who have cholestatic itch often present with secondary lesions from scratching in an attempt to alleviate pruritus. Patients consider pruritus one of the most distressing symptoms of their cholestatic disease and report a significant decrease in quality of life as a result of pruritus. The pathogenesis of cholestatic pruritus is diverse, complex, and not clearly delineated. Cholestatic pruritus can occur at any stage of liver disease. Its intensity is often exacerbated by psychological stress, heat, and contact with wool. Cold temperatures often produce symptom relief. Moreover, pruritus is more common in women. A presumptive diagnosis of cholestatic pruritus can be made in patients with cholestasis who complain of itching. However, when there is no known cause of cholestasis, it should be considered that approximately one in five patients with generalized pruritus has a systemic disease. Assuming that the unknown pathogenesis of cholestatic pruritus is one of the factors preventing the development of effective therapy, it is understood why treatment options are limited and still do not provide relief for all patients.

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

Cholestatic Pruritus Emerging Drugs Chapters

This segment of the Cholestatic Pruritus report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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.

Cholestatic Pruritus Emerging Drugs

Volixibat: Mirum Pharmaceuticals Volixibat is an oral, minimally absorbed agent designed to selectively inhibit the apical sodium dependent bile acid transporter (ASBT). Volixibat may offer a novel approach in the treatment of adult cholestatic diseases by blocking the recycling of bile acids, through inhibition of ASBT, thereby reducing bile acids systemically and in the liver. Phase 1 and Phase 2 studies of volixibat demonstrated on-target fecal bile acid excretion, a pharmacodynamic marker of ASBT inhibition, in addition to decreases in LDL cholesterol and increases in 7aC4 which are markers of bile acid synthesis. Volixibat has been evaluated in more than 400 individuals across multiple clinical trials. The most common adverse events reported were mild to moderate gastrointestinal events observed in the volixibat groups. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Cholestatic Pruritus.

Linerixibat: Glaxo SmithKlineLinerixibat is an investigational product for the treatment of cholestatic pruritus in patients with PBC and it is not currently approved for use anywhere in the world. In 2019, FDA granted orphan drug designation for linerixibat in the treatment of PBC and associated cholestatic pruritus. Linerixibat is a minimally absorbed small molecule inhibitor of IBAT administered as an oral tablet. By blocking resorption of bile acids in the small intestine, linerixibat reduces pruritic bile acids in circulation. Currently, the drug is in Phase III stage of Clinical trial evaluation for the treatment of CholestaticPruritus.

Cholestatic Pruritus: Therapeutic Assessment

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

Major Players in Cholestatic Pruritus

There are approx. 6+ key companies which are developing the therapies for Cholestatic Pruritus. The companies which have their Cholestatic Pruritus drug candidates in the most advanced stage, i.e. phase III include, GlaxoSmithKline.

Phases

This report covers around 6+ 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

Cholestatic Pruritus pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

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

Cholestatic Pruritus: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Cholestatic Pruritus 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 Cholestatic Pruritus drugs.

Cholestatic Pruritus Report Insights

• Cholestatic Pruritus Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Escient Pharmaceuticals
• Cara Therapeutics
• GlaxoSmithKline
• CymaBay Therapeutics
• Mirum Pharmaceuticals

Key Products

• Volixibat
• Linerixibat
• EP547

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