Bezlotoxumab is a fully humanized IgG1κ monoclonal antibody targets the intact full-length of Clostridium difficile toxin B and its peptides. It was developed for reducing the recurrence of C Clostridium difficile infection (CDI) in adults receiving antibiotic therapy to treat C. difficile infection and high risk of recurrence. With the trade name Zinplava, bezlotoxumab has been approved for marketing in USA, European Union, Japan, and Australia.
Two homologous exotoxins, toxin A and toxin B, are predominantly responsible for the pathogenic effects of CDI. These exotoxins lead to an increase in gut wall permeability and an acute proinflammatory response leading to diarrhea and potentially more severe symptoms of CDI. Bezlotoxumab works against toxin B by providing passive immunity against toxins produced by persistent C. difficile spores that remain after treatment of an initial CDI episode. Bezlotoxumab selectively binds to toxin B, neutralizing the effect of toxin B, and prevents toxin B from binding to mammalian cells. It binds to two distinct epitopes within the N-terminal half of the toxin B combined repetitive oligopeptide domain to prevent C. difficile toxin binding to host cells. Through this mechanism, bezlotoxumab is able to reduce the risk of recurrent CDI in adult patients receiving concomitant antibiotic treatment for CDI.
Fig.1 Mechanism of action of bezlotoxumab
NCT ID | Status | Conditions | Lead Sponsor | Update Time |
NCT03182907 | Recruiting | Clostridium Difficile Infection | Merck Sharp & Dohme Corp. | June 9, 2017 |
INN (trade name) | Therapeutic area | Dose | Strength | Route | Company | Marketing start | Market |
Zinplava | Clostridium difficile infection | Injection, Solution | 25 mg/mL | Intravenous | Merck Sharp Dohme | October 21, 2016 | |
Zinplava | Enterocolitis, Pseudomembranous | Injection, Solution | 25 mg/mL | Intravenous | Merck Sharp & Dohme Limited | January 18, 2017 | |
Zinplava | Clostridium difficile infection | Injection, Solution | 25 mg/mL | Intravenous | MSD K.K. | September 27, 2017 | |
Zinplava | Clostridium difficile infection | Injection, Solution | 25 mg/mL | Intravenous | Merck Sharp & Dohme (Australia) Pty Ltd | December 13, 2017 |
We provide high-quality Bezlotoxumab for use in WB, FC, IP, ELISA, Neut, FuncS, IF and most other immunological methods. For lab research use only, not for diagnostic, therapeutic or any in vivo human use.
Resources
* The table was excerpted from the following website
https://clinicaltrials.gov/ct2/results?cond=&term=Bezlotoxumab
** Information presented in the table were collected from the following websites:
http://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/6399426A1
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo= 761046
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004136/human_med_002062.jsp
http://search.tga.gov.au/s/search.html?collection=tga-artg&profile=record&meta_i=281878
For research use only. Not intended for any clinical use.
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