PUBLISHER: DelveInsight | PRODUCT CODE: 1381082
PUBLISHER: DelveInsight | PRODUCT CODE: 1381082
“"ZINPLAVA Drug Insight and Market Forecast - 2032" report provides comprehensive insights about ZINPLAVA for Clostridium Difficile Infection (CDI) in the seven major markets. A detailed picture of the ZINPLAVA 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 ZINPLAVA 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 ZINPLAVA 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.
ZINPLAVA (bezlotoxumab), developed by Merck Sharp & Dohme LLC (MSD) is a human monoclonal antibody that binds to C. difficile Toxin B, indicated to reduce the recurrence of CDI in patients 18 years or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence. In vitro studies in cell-based assays using Vero cells or Caco-2 cells suggest that the drug neutralizes the toxic effects of toxin B. ZINPLAVA is used in conjunction with antibacterial drug treatment of CDI.
The FDA approval of ZINPLAVA was based on two Phase III trials, MODIFY I and II. ZINPLAVA is not an antibacterial drug and is not indicated for the treatment of CDI (Merck, 2016a). In May 2022, Merck completed the Phase III trial (MODIFY III) for rCDI in children aged 1 to <18 years of age with a confirmed diagnosis of CDI.
The recommended dose of ZINPLAVA for CDI patients is a single dose of 10 mg/kg administered as an intravenous infusion over 60 min. The drug should be administered during antibacterial drug treatment for CDI.
ZINPLAVA is a human monoclonal IgG1/kappa antibody, which binds to the Toxin B of C. difficile, inhibits the binding of the toxin B to the colonocytes, and neutralizes the toxin. The drug binds to the two epitopes within the N-terminal half of the CROP domain of the toxin through its two Fab regions to block the carbohydrate-binding pockets of the toxin and prevents the toxin from binding to the host cells. However, it does not bind to C. difficile toxin A.
The report provides insights into:
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.
This report provides a detailed market assessment of ZINPLAVA 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 2023 to 2032.
The report provides the clinical trials information of ZINPLAVA for clostridium difficile infection covering trial interventions, trial conditions, trial status, start and completion dates.