BLAINJECTIONINJECTABLEPriority Review
Approved
Oct 2016
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZINPLAVA (bezlotoxumab) is a monoclonal antibody that neutralizes Clostridioides difficile toxin B, reducing recurrent CDI in patients at high risk. It is indicated for CDI prevention and is also being evaluated in ulcerative colitis, Crohn's disease, and inflammatory bowel disease. The drug works by binding and inactivating toxin B, a key virulence factor in CDI pathogenesis.
$632KPart D
PeakStable
Product is at peak lifecycle with modest Part D utilization; commercial team size likely stable but not expanding aggressively.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection
Started Feb 2020
180 enrolled
Clostridium Difficile InfectionClostridium Difficile Infection Recurrence
Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
Started Oct 2019
869 enrolled
Clostridium Difficile Infection
Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.
Started Aug 2019
1 enrolled
Clostridium Difficile
Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.
Started Aug 2019
5 enrolled
Clostridia Difficile ColitisClostridium; Sepsis
Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection
Started Jun 2019
4 enrolled
Clostridium Difficile Infection Recurrence
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.