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Zinplava (BEZLOTOXUMAB)
Zinplava (generic name: BEZLOTOXUMAB) is a Monoclonal antibody drug developed by Merck & Co.. It is currently FDA-approved (first approved 2016) for Clostridium difficile infection.
Zinplava works by binding to and neutralizing toxins produced by Clostridium difficile bacteria.
Zinplava, also known as bezlotoxumab, is an antibody that inhibits Toxin B, a toxin produced by Clostridium difficile. It is used to prevent recurrence of Clostridium difficile infection and has also been studied for its potential use in treating inflammatory bowel diseases.
At a glance
| Generic name | BEZLOTOXUMAB |
|---|---|
| Sponsor | Merck & Co. |
| Modality | Monoclonal antibody |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2016 |
Mechanism of action
ZINPLAVA (bezlotoxumab) is human monoclonal antibody that binds to C. difficile toxin and neutralizes its effects [see Microbiology (12.4)].
Approved indications
- Clostridium difficile infection
Common side effects
- Mortality
- Heart failure
- Ventricular tachyarrhythmia
- Nausea
- Pyrexia
- Headache
- Gastrointestinal disorders
- General disorders and administration site conditions
- Nervous system disorders
- Infusion Related Reactions
- Fatigue
- Dizziness
Key clinical trials
- Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection (PHASE2)
- ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI (PHASE2)
- Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). (PHASE4)
- Rescue FMT with Bezlotoxumab for Recurrent C. Difficile Infection
- Addressing Personalized Needs in Clostridioides Difficile Infection (NA)
- Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001) (PHASE3)
- Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
- Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery. (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Zinplava CI brief — competitive landscape report
- Zinplava updates RSS · CI watch RSS
- Merck & Co. portfolio CI
Frequently asked questions about Zinplava
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Related
- Manufacturer: Merck & Co. — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Clostridium difficile infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing