Obeticholic acid Emerging Drug Insight

“Obeticholic acid Market Size, Forecast, and Emerging Insight – 2032” report provides comprehensive insights about Obeticholic acid for Liver fibrosis in the seven major markets. A detailed picture of the Obeticholic acid for Liver fibrosis in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019–2032 is provided in this report along with a detailed description of the Obeticholic acid for Liver fibrosis. The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the Obeticholic acid market forecast, analysis for Liver fibrosis in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Liver fibrosis.

Drug Summary

Obeticholic acid (OCA) is a synthetic derivative of the endogenous primary bile acid, chenodeoxycholic acid. Obeticholic acid was developed primarily to treat liver and bile duct pathologies. It has established potency as an anti-cholestatic and antihepatotoxic agent. Currently, OCA has approval from the FDA to treat primary biliary cholangitis (PBC). The use of OCA for primary sclerosing cholangitis and NASH is still under development.

Mechanism of action

Obeticholic acid is a modified, synthetic bile acid that acts as a farnesoid X-activated receptor (FXR) agonist. Farnesoid X-activated receptors are primarily expressed in human enterocytes and hepatocytes, and naturally occurring bile acids are most often the ligands for FXRs. In the enterocytes, FXRs regulate the synthesis of bile acids and release fibroblast growth factor, specifically FGF-19, into the hepatic portal circulation.

In January 2023, the US FDA accepted the company’s NDA for OCA in pre-cirrhotic liver fibrosis due to NASH. FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 22, 2023, for the application. Intercept anticipates an advisory committee meeting as part of the FDA review process.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the Obeticholic acid description, mechanism of action, dosage and administration, research and development activities in Liver fibrosis.
• Elaborated details on Obeticholic acid regulatory milestones and other development activities have been provided in this report.
• The report also highlights the Obeticholic acid research and development activity in Liver fibrosis in detail across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around Obeticholic acid.
• The report contains forecasted sales of Obeticholic acid for Liver fibrosis till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Liver fibrosis.
• The report also features the SWOT analysis with analyst views for Obeticholic acid in Liver fibrosis.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Obeticholic acid Analytical Perspective by DelveInsight

In-depth Obeticholic acid Market Assessment

This report provides a detailed market assessment of Obeticholic acid in Liver fibrosis in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2026 to 2032.

Obeticholic acid Clinical Assessment

The report provides the clinical trials information of Obeticholic acid in Liver fibrosis covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for Liver fibrosis is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Obeticholic acid dominance.
• Other emerging products for Liver fibrosis are expected to give tough market competition to Obeticholic acid and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Obeticholic acid in Liver fibrosis.
• Our in-depth analysis of the forecasted sales data from 2026 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Obeticholic acid in Liver fibrosis.

Key Questions

• What is the product type, route of administration and mechanism of action of Obeticholic acid?
• What is the clinical trial status of the study related to Obeticholic acid in Liver fibrosis and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Obeticholic acid development?
• What are the key designations that have been granted to Obeticholic acid for Liver fibrosis?
• What is the forecasted market scenario of Obeticholic acid for Liver fibrosis?
• What are the forecasted sales of Obeticholic acid in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available in Liver fibrosis and how are they giving competition to Obeticholic acid for Liver fibrosis?
• Which are the late-stage emerging therapies under development for the treatment of Liver fibrosis?