ZINPLAVA
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.
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
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
ProIndications & 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...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.