Overview

Bezlotoxumab is a fully humanized ImmunoglobulinG1 (IgG1) kappa monoclonal antibody that binds to Clostridium difficile toxin B and neutralizes its effects. First approved by the FDA on October 21, 2016, bezlotoxumab is used to reduce the recurrence of C. difficile infection. On November 22, 2016, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the granting of a marketing authorization. The drug was granted full approval by the EMA on January 18, 2017.

Indication

Bezlotoxumab is indicated to reduce the recurrence of Clostridioides difficile infection (CDI) in patients who are receiving antibacterial drug treatment for CDI and are at high risk for CDI recurrence. In the US, the drug is approved for use in patients one year of age and older. In Europe, it is approved in adults only.

Associated Conditions

Clostridium difficile infection recurrence

Research Report

Published: Sep 1, 2025

Bezlotoxumab (Zinplava): A Comprehensive Monograph on a Novel Therapeutic for Recurrent Clostridioides difficile Infection

Executive Summary

Bezlotoxumab, marketed under the brand name Zinplava, represents a landmark achievement in infectious disease therapy as the first-in-class, fully human monoclonal antibody specifically engineered to prevent the recurrence of Clostridioides difficile infection (CDI).[1] By selectively targeting and neutralizing

C. difficile Toxin B, the primary cytotoxin responsible for the cyclical nature of the disease, bezlotoxumab offered a novel, non-antibiotic approach to a significant unmet medical need.[3] Its clinical development program, culminating in the pivotal MODIFY I and II trials, demonstrated statistically significant and clinically meaningful efficacy in reducing CDI recurrence, particularly within well-defined high-risk patient populations, including the elderly and immunocompromised.[4] This robust efficacy profile led to widespread regulatory approvals, including from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).[6]

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection	2022/03/31	NCT05304715	Phase 2	Completed	Hellenic Institute for the Study of Sepsis
Bezlotoxumab Versus FMT for Multiple Recurrent CDI	2021/10/13	NCT05077085	Phase 4	Withdrawn	Leiden University Medical Center
Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).	2020/11/13	NCT04626947	Phase 4	Terminated	David Binion, MD
Bezlotoxumab Efficacy and Tolerability in Cancer Patient	2020/06/04	NCT04415918	Phase 4	UNKNOWN	The Cooper Health System
Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.	2019/08/30	NCT04075422	N/A	Completed	Fundacion SEIMC-GESIDA
Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.	2019/05/06	NCT03937999	Phase 4	Terminated	Montefiore Medical Center
Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection	2019/03/19	NCT03880539	Phase 4	Completed	University of Kansas Medical Center
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI	2019/02/04	NCT03829475	Phase 2	Active, not recruiting	Brigham and Women's Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ZINPLAVA	Merck Sharp & Dohme LLC	0006-3025	INTRAVENOUS	25 mg in 1 mL	5/26/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Zinplava	Merck Sharp & Dohme B.V.,Waarderweg 39,2031 BN Haarlem,The Netherlands	Authorised	1/18/2017

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ZINPLAVA 25 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Merck Sharp & Dohme B.V.	1161156001	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Lumen Bioscience's Oral Biologic LMN-201 Achieves 100% Clinical Cure Rate for C. difficile Infection in Preliminary Trial

5 months ago

Lumen Bioscience's investigational oral biologic LMN-201 achieved a 100% clinical cure rate in all 21 patients of the sentinel cohort in the RePreve trial for C. difficile infection, significantly outperforming standard treatments.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access

Bezlotoxumab