Cholestatic Pruritus clinical trials are ongoing with novel agents that demonstrate potential efficacious options in the future. The key players such as Escient Pharmaceuticals, Cara Therapeutics, GlaxoSmithKline, CymaBay Therapeutics, Mirum Pharmaceuticals, and others are developing Cholestatic Pruritus therapies to improve treatment outlook.
Los Angeles, USA, March 25, 2021 (GLOBE NEWSWIRE) -- Newer approaches for the management of Cholestatic Pruritus treatment outlook
Cholestatic Pruritus clinical trials are ongoing with novel agents that demonstrate potential efficacious options in the future. The key players such as Escient Pharmaceuticals, Cara Therapeutics, GlaxoSmithKline, CymaBay Therapeutics, Mirum Pharmaceuticals, and others are developing Cholestatic Pruritus therapies to improve treatment outlook.
DelveInsight’s “Cholestatic Pruritus Pipeline Insight” report provides comprehensive insights about 6+ companies and 6+ pipeline drugs in the Cholestatic Pruritus pipeline landscapes. It comprises Cholestatic Pruritus pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Cholestatic Pruritus therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Cholestatic Pruritus pipeline products.
In September 2019, the US FDA granted orphan drug designation to linerixibat for the Primary Biliary Cholangitis treatment.
In 2020, GlaxoSmithKline announced further progression in its R&D pipeline with the data presentation of linerixibat, an investigational product for the potential treatment of Cholestatic Pruritus in patients with Primary Biliary Cholangitis.
Many key players such as Escient Pharmaceuticals, Cara Therapeutics, GlaxoSmithKline, CymaBay Therapeutics, Mirum Pharmaceuticals, and others are involved in Cholestatic Pruritus therapeutics development.
In September 2020, Escient Pharmaceuticals announced the completion of a $77.5 million Series B financing and the initiation of a Phase 1/1b clinical trial of EP547, a MRGPRX4-targeted product candidate to treat cholestatic and uremic pruritus.
Cholestasis is a reduction in bile flow because of the impaired secretion by hepatocytes or due to the obstruction of bile flow through intra-or extra-hepatic bile ducts. Furthermore, Pruritus is a distressing manifestation of both intra-hepatic cholestasis and extra-hepatic biliary obstruction.
GSK2330672 is a selective inhibitor of human IBAT and is designed to be a non-absorbable agent restricted to the gastrointestinal (GI) tract. The drug is expected to block the uptake of bile acids (BAs) in the terminal ileum, increase their excretion in the faeces and reduce the amount of BAs returning to the liver via enterohepatic circulation. Therefore, the treatment of PBC patients with oral GSK2330672 is postulated to reduce the concentrations of BAs in the systemic circulation, and in turn, improve pruritus. The company has completed the Phase II stage of clinical development, and the drug is currently conducting phase III trials.
Research and Development
Phase III Clinical Studies
NCT04167358: In July 2020, GlaxoSmithKline initiated a trial titled “Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis”. The trial is currently recruiting participants with an estimated enrollment of 75 participants and is expected to be completed by December 2024.
Phase II Results: In 2020, GlaxoSmithKline announced further progression in its R&D pipeline with the data presentation of linerixibat, an investigational product for the potential treatment of Cholestatic Pruritus in patients with Primary Biliary Cholangitis (PBC). The dose of linerixibat showed significant improvements from baseline in measures of quality of life, including social and emotional domains of the disease-specific patient-reported instrument, PBC-40, in the overall population. Due to the mechanism of action of linerixibat, the most common adverse events were diarrhoea and abdominal pain.
What are the current options for Cholestatic Pruritus treatment?
How many companies are developing therapies for the treatment of Cholestatic Pruritus?
How many are Cholestatic Pruritus emerging therapies in the early-stage, mid-stage, and late stages of development to treat Cholestatic Pruritus?
What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and significant licensing activities that will impact the Cholestatic Pruritus market?
Which are the dormant and discontinued products and the reasons for the same?
What is the unmet need for current therapies for the treatment of Cholestatic Pruritus?
What are the current novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing Cholestatic Pruritus therapies?
What are the critical designations that have been granted for the emerging therapies for Cholestatic Pruritus?
How many patents are granted and pending for the emerging therapies to treat Cholestatic Pruritus?
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