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Bezlotoxumab Overview

Introduction of Bezlotoxumab

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.

Mechanism of Action of Bezlotoxumab

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.

Mechanism of action of bezlotoxumab Fig.1 Mechanism of action of bezlotoxumab

Clinical Projects of Bezlotoxumab*

NCT ID Status Conditions Lead Sponsor Update Time
NCT03182907 Recruiting Clostridium Difficile Infection Merck Sharp & Dohme Corp. June 9, 2017

Approved Drugs of Bezlotoxumab**

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

What We Provide

Therapeutic Antibody
Bezlotoxumab
Bezlotoxumab

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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