“CSL312 - Emerging Insight and Market Forecast- 2030” the report provides comprehensive insights about an investigational product for Hereditary Angioedema (HAE) in 7 Major Markets. A detailed picture of the CSL312 in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2020–2030 is provided in this report along with a detailed description of the product. The product details cover mechanism of action, dosage and administration, route of synthesis, and Research and development activity including regulatory milestones, and other development activities. Further, it also consists of future market assessments inclusive of the market forecast, SWOT analysis, market competitors, and other emerging therapies.
Overview Garadacimab (previously known as CSL312) is a novel Factor XIIa-inhibitory monoclonal antibody (FXIIa mAb) currently in Phase 3 clinical development as a new type of once-monthly subcutaneous prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema. Garadacimab inhibits the plasma protein, FXIIa. When FXIIa is activated, it initiates the cascade of events leading to edema formation. By targeting FXIIa, garadacimab can prevent the initiation of this cascade. The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to garadacimab as an investigational therapy for the prevention of bradykinin-mediated angioedema. CSL Behring is also investigating garadacimab for other indications, beyond HAE, where FXIIa inhibition may be a factor in improving clinical outcomes.
Scope of the report The report provides insights into:
• A comprehensive product overview including the product description, mechanism of action, dosage and administration, Research and Development activity.
• Elaborated details on regulatory milestones and other development activities have been provided in this report.
• The report also highlights the drug research and development activity details across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around CSL312.
• The report contains forecasted sales for CSL312 till 2030.
• Comprehensive coverage of the late-stage emerging therapies (Phase III) for Hereditary Angioedema.
• The report also features the SWOT analysis with analyst insights and key findings of CSL312.
Methodology The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the 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.
CSL312 Analytical Perspective • In-depth CSL312 Market Assessment
This report provides a detailed market assessment of CSL312 in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2020 to 2030.
• CSL312 Clinical Assessment
The report provides the clinical trials information of CSL312 covering trial interventions, trial conditions, trial status, start and completion dates.
Report highlights • In the coming years, the market scenario for Hereditary Angioedema 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 and academics are working to assess challenges and seek opportunities that could influence CSL312 dominance. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Other emerging products for Hereditary Angioedema are giving market competition to CSL312 and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, development activities, and some key findings provide the current development scenario of CSL312.
• Our in-depth analysis of the forecasted sales data of CSL312 from 2020 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the CSL312.
Key Questions • Which company is developing CSL312 along with the phase of the clinical study?
• What is the technology utilized in the development of CSL312?
• What is the product type, route of administration and mechanism of action of CSL312?
• What is the clinical trial status of the study and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the CSL312 development?
• What are the key designations that have been granted to CSL312?
• What is the forecasted market scenario of CSL312?
• What is the history of CSL312 and what is its future?
• What is the forecasted sales of CSL312 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 and how these are giving competition to CSL312?
• Which are the late-stage emerging therapies under development for the treatment of the PPD?
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