This “DIFICID Drug Insight and Market Forecast - 2032” report provides comprehensive insights about DIFICID for clostridium difficile infection (CDI) in the seven major markets. A detailed picture of the DIFICID for clostridium difficile infection 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 DIFICID for clostridium difficile infection. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the DIFICID market forecast analysis for clostridium difficile infection in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in clostridium difficile infection.
Fidaxomicin (also known as OPT-80 and PAR-101) is a novel antibiotic agent, and the first representative of a new class of antibacterials called macrocycles. It has a narrow-spectrum antibacterial profile mainly directed against C. difficile and exerts moderate activity against some other gram-positive species. The drug product is poorly absorbed and exerts its activity in the gastrointestinal (GI) tract, which is an advantage when used in the applied indication and treatment of CDI (also known as CDAD).
Dosage and administration
DIFICID is administered orally with or without food. The recommended dosage for adults is one 200 mg DIFICID tablet orally twice daily for 10 days. For pediatric patients weighing at least 12.5 kg and can swallow tablets, the recommended dosage is one 200 mg DIFICID tablet orally twice daily for 10 days. If unable to swallow tablets, pediatric patients may be dosed with DIFICID oral suspension.
The structure of fidaxomicin includes an unsaturated 18-membered macrocyclic core. It is isolated from a strain of the bacterium dactylosporangium aurantiacum and is a member of the tiacumicin family. Fidaxomicin inhibits bacterial protein synthesis by binding to RNA polymerase. The bactericidal activity against C. difficile is followed by a post-antibiotic effect of 6-10 h for fidaxomicin and 3 h with OP-1118, its active metabolite.
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Drug Summary
DIFICID (fidaxomicin), manufactured by Merck & Co and Astellas Pharma, is a macrolide antibiotic used to treat CDAD in adults and children 6 months of age or older. C. difficile is a bacterium that can cause an infection that can damage the colon and cause stomach pain and severe diarrhea.Fidaxomicin (also known as OPT-80 and PAR-101) is a novel antibiotic agent, and the first representative of a new class of antibacterials called macrocycles. It has a narrow-spectrum antibacterial profile mainly directed against C. difficile and exerts moderate activity against some other gram-positive species. The drug product is poorly absorbed and exerts its activity in the gastrointestinal (GI) tract, which is an advantage when used in the applied indication and treatment of CDI (also known as CDAD).
Dosage and administration
DIFICID is administered orally with or without food. The recommended dosage for adults is one 200 mg DIFICID tablet orally twice daily for 10 days. For pediatric patients weighing at least 12.5 kg and can swallow tablets, the recommended dosage is one 200 mg DIFICID tablet orally twice daily for 10 days. If unable to swallow tablets, pediatric patients may be dosed with DIFICID oral suspension.
The structure of fidaxomicin includes an unsaturated 18-membered macrocyclic core. It is isolated from a strain of the bacterium dactylosporangium aurantiacum and is a member of the tiacumicin family. Fidaxomicin inhibits bacterial protein synthesis by binding to RNA polymerase. The bactericidal activity against C. difficile is followed by a post-antibiotic effect of 6-10 h for fidaxomicin and 3 h with OP-1118, its active metabolite.
Scope of the Report
The report provides insights into:
- A comprehensive product overview including the DIFICID description, mechanism of action, dosage and administration, research and development activities in clostridium difficile infection.
- Elaborated details on DIFICID regulatory milestones and other development activities have been provided in this report.
- The report also highlights the DIFICID research and development activities in clostridium difficile infection across the United States, Europe and Japan.
- The report also covers the patents information with expiry timeline around DIFICID.
- The report contains forecasted sales of DIFICID for clostridium difficile infection till 2032.
- Comprehensive coverage of the late-stage emerging therapies for clostridium difficile infection.
- The report also features the SWOT analysis with analyst views for DIFICID in clostridium difficile infection.
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.DIFICID Analytical Perspective
In-depth DIFICID Market Assessment
This report provides a detailed market assessment of DIFICID for clostridium difficile infection in the seven major markets, 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 2025 to 2032.DIFICID Clinical Assessment
The report provides the clinical trials information of DIFICID for clostridium difficile infection covering trial interventions, trial conditions, trial status, start and completion dates.Report Highlights
- In the coming years, the market scenario for clostridium difficile infection 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 DIFICID dominance.
- Other emerging products for clostridium difficile infection are expected to give tough market competition to DIFICID 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 DIFICID in clostridium difficile infection.
- This in-depth analysis of the forecasted sales data of DIFICID from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the DIFICID in clostridium difficile infection.
Key Questions
- What is the product type, route of administration and mechanism of action of DIFICID?
- What is the clinical trial status of the study related to DIFICID in clostridium difficile infection and study completion date?
- What are the key collaborations, mergers and acquisitions, licensing and other activities related to the DIFICID development?
- What are the key designations that have been granted to DIFICID for clostridium difficile infection?
- What is the forecasted market scenario of DIFICID for clostridium difficile infection?
- What are the forecasted sales of DIFICID 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 are these giving competition to DIFICID for clostridium difficile infection?
- Which are the late-stage emerging therapies under development for the treatment of clostridium difficile infection?
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Table of Contents
1. Report Introduction3. Competitive Landscape (Marketed Therapies)4. Competitive Landscape (Late-stage Emerging Therapies)6. SWOT Analysis7. Analysts’ Views9. Publisher Capabilities10. Disclaimer11. About the Publisher12. Report Purchase Options
2. DIFICID Overview in Clostridium difficile infection
5. DIFICID Market Assessment
8. Appendix
List of Tables
List of Figures