ZINPLAVA is a human monoclonal antibody indicated to reduce the recurrence of Clostridioides difficile infection (CDI) in adult and pediatric patients aged one year and older. It is specifically for patients who are currently receiving antibacterial drug treatment for CDI and are at a high risk for the infection to return. The drug is not an antibacterial agent and is not indicated for the treatment of an active CDI. Consequently, it must be used only in conjunction with antibacterial therapy.
How ZINPLAVA Works
ZINPLAVA is a human monoclonal antibody that targets and binds to Clostridioides difficile toxin B. By binding to this specific toxin, the drug neutralizes its harmful biological effects. This action helps to prevent the recurrence of the infection in patients already undergoing antibacterial treatment. It does not directly target the bacteria itself, but rather the toxins produced by the pathogen.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-10-21
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ZINPLAVA Approval History
What ZINPLAVA Treats
1 indicationsZINPLAVA is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clostridioides Difficile Infection
ZINPLAVA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05304715 BEYOND results posted | BEYOND 2021-005473-10 | Ph 2 | completed | Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection |
| NCT03829475 ICON-2 results posted | 2018 | Ph 2 | completed | ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI |
| NCT04626947 results posted | STUDY19100301 | Ph 4 | terminated | Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). |
| NCT03182907 MODIFY III results posted | 6072-001 MK-6072-001, 2017-000070-11 | Ph 3 | completed | Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001) |
| NCT03756454 results posted | 2018H0348 | Ph 4 | terminated | Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery. |
| NCT05077085 BSTEP | BSTEP | Ph 4 | withdrawn | Bezlotoxumab Versus FMT for Multiple Recurrent CDI |
| NCT03937999 results posted | 2019-10212 | Ph 4 | terminated | Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics. |
| NCT03880539 BEZLO | Study00143405 | Ph 4 | completed | Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZINPLAVA FDA Label Details
Indications & Usage
FDA Label (PDF)ZINPLAVA™ is indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence. ZINPLAVA is a human monoclonal antibody that binds to Clostridioides difficile toxin B, indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence. Limitation of Use: ZINPLAVA is not indi...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment