Drug Summary
Setanaxib (GKT831) is a potent, dual NADPH oxidase NOX1/NOX4 inhibitor; treatment with setanaxib suppresses reactive oxygen species (ROS) production. NOX enzymes are the only known enzymes that are solely dedicated to producing ROS. At appropriate concentrations, ROS help regulate cell proliferation, differentiation, and migration, as well as modulate the innate immune response, inflammation, and fibrosis. Setanaxib has shown evidence of antifibrotic activity in Phase II clinical trials in PBC. Based on its Phase II results, Calliditas is conducting a Phase II/III trial with setanaxib in PBC.The first patient has been randomized in Calliditas's pivotal Phase IIb/III TRANSFORM study in patients with PBC.
Scope of the Report
The report provides insights into:
- A comprehensive product overview including the setanaxib description, mechanism of action, dosage and administration, research and development activities in primary biliary cholangitis (PBC).
- Elaborated details on setanaxib regulatory milestones and other development activities have been provided in this report.
- The report also highlights the setanaxib research and development activities in PBC across the United States, Europe, Japan and China.
- The report also covers the patents information with expiry timeline around setanaxib.
- The report contains forecasted sales of setanaxib for PBC till 2032.
- Comprehensive coverage of the late-stage emerging therapies for PBC.
- The report also features the SWOT analysis with analyst views for setanaxib PBC.
Methodology
The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the publisher'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.Setanaxib Analytical Perspective
In-depth Setanaxib Market Assessment
This report provides a detailed market assessment of setanaxib for primary biliary cholangitis (PBC) in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan and China. This segment of the report provides forecasted sales data from 2026 to 2032.Setanaxib Clinical Assessment
The report provides the clinical trials information of setanaxib for PBC covering trial interventions, trial conditions, trial status, start and completion dates.Report Highlights
- In the coming years, the market scenario for primary biliary cholangitis (PBC) 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 setanaxib dominance.
- Other emerging products for PBC are expected to give tough market competition to setanaxib 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 setanaxib in PBC.
- Our in-depth analysis of the forecasted sales data of setanaxib from 2026 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the setanaxib in PBC.
Key Questions Answered
- What is the product type, route of administration and mechanism of action of setanaxib?
- What is the clinical trial status of the study related to setanaxib in primary biliary cholangitis (PBC) and study completion date?
- What are the key collaborations, mergers and acquisitions, licensing and other activities related to the setanaxib development?
- What are the key designations that have been granted to setanaxib for PBC?
- What is the forecasted market scenario of setanaxib for PBC?
- What are the forecasted sales of setanaxib in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), Japan and China?
- What are the other emerging products available and how are these giving competition to setanaxib for PBC?
- Which are the late-stage emerging therapies under development for the treatment of PBC?
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