Drug

Bezlotoxumab

Approved · EMA

Emerging researchLate-stage development

Also known as Zinplava.

RxNorm1855048UNII4H5YMK1H2E

Research papers

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection: The BEYOND Double-Blind Randomized Clinical Trial

Clinical trial2026-03-04Results posted · ClinicalTrials.gov

A Randomized Controlled Trial to Compare the Effectiveness of Fecal Microbiota Transplantation (FMT) in Combination With Bezlotoxumab Compared to FMT and Placebo for the Prevention of CDI Recurrence in Patients With Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection

Clinical trial2025-12-09Results posted · ClinicalTrials.gov

New Treatment Strategy for Patients With Multiple Recurrent Clostridioides Difficile Infection With Bezlotoxumab as First Option

Clinical trial2024-12-01Withdrawn · ClinicalTrials.gov

Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).

Clinical trial2024-05-31Terminated · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Infusion of Bezlotoxumab (MK-6072, Human Monoclonal Antibody to C. Difficile Toxin B) in Children Aged 1 to <18 Years Receiving Antibacterial Drug Treatment for C. Difficile Infection (MODIFY III)

Clinical trial2023-07-27Results posted · ClinicalTrials.gov

Double-Blind, Placebo-Controlled Study of Bezlotoxumab in Children Receiving Antibacterial Treatment for Clostridioides difficile Infection (MODIFY III).

Research2023-06-01Journal of the Pediatric Infectious Diseases Society

A Prospective, Double-blind, Randomized, and Controlled Clinical Trial to Compare the Effectiveness of Intravenous Bezlotoxumab (10 mg/kg) Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant Clostridioides Difficile Requiring Surgical Intervention.

Clinical trial2022-05-23Terminated · ClinicalTrials.gov

A Pragmatic Trial of Secondary Prophylaxis With Bezlotoxumab to Prevent C. Difficile Relapse Among Hospitalized Adults Receiving Antibiotics.

Clinical trial2022-05-15Terminated · ClinicalTrials.gov

Historically-controlled Clinical Trial of the Efficacy and Safety of Bezlotoxumab (BEZLO) in Addition to Standard of Care (SOC) Vancomycin for the Treatment of Multi-recurrent Clostridium Difficile Infection (CDI)

Clinical trial2021-11-18Completed · ClinicalTrials.gov

Is Bezlotoxumab Effective, Tolerable and Cost Saving in Preventing Recurrent Clostridium Difficile Infections in Patients With Malignancies? An Exploratory Study

Clinical trial2021-07-01Primary completion · ClinicalTrials.gov

Approval: Zinplava (EMA)

Regulatory2017-01-18EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Bezlotoxumab

Aliases & brands

Zinplava

RxNorm CUI

1855048

UNII

4H5YMK1H2E

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2017-01-18

Latest approval

2017-01-18

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2017-01-18Approval

Approval: Zinplava (EMA)

Indication: Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.