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Bezlotoxumab Injection
Bezlotoxumab is a monoclonal antibody that binds to and neutralizes Clostridioides difficile toxin B, preventing its pathogenic effects on the intestinal epithelium.
Bezlotoxumab is a monoclonal antibody that binds to and neutralizes Clostridioides difficile toxin B, preventing its pathogenic effects on the intestinal epithelium. Used for Clostridioides difficile infection (CDI) — to reduce recurrence in patients at high risk.
At a glance
| Generic name | Bezlotoxumab Injection |
|---|---|
| Also known as | No intervention |
| Sponsor | The Cooper Health System |
| Drug class | Monoclonal antibody (toxin-neutralizing) |
| Target | Clostridioides difficile toxin B |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Bezlotoxumab specifically targets toxin B produced by C. difficile, one of the two major virulence factors responsible for disease pathogenesis. By neutralizing toxin B before it can damage intestinal cells, the drug reduces inflammation, prevents epithelial injury, and decreases the risk of recurrent C. difficile infection (CDI). This mechanism allows the host immune system and normal microbiota to recover without ongoing toxin-mediated damage.
Approved indications
- Clostridioides difficile infection (CDI) — to reduce recurrence in patients at high risk
Common side effects
- Infusion-related reactions
- Headache
- Nausea
- Fatigue
Key clinical trials
- Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
- Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics. (PHASE4)
- Bezlotoxumab Efficacy and Tolerability in Cancer Patient (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 |
|---|---|
| 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:
- Bezlotoxumab Injection CI brief — competitive landscape report
- Bezlotoxumab Injection updates RSS · CI watch RSS
- The Cooper Health System portfolio CI