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CroFab
CroFab is a polyclonal antivenom that binds and neutralizes venom toxins from North American crotalid snakes (rattlesnakes, cottonmouths, and copperheads).
CroFab is a polyclonal antivenom that binds and neutralizes venom toxins from North American crotalid snakes (rattlesnakes, cottonmouths, and copperheads). Used for Envenomation by North American crotalid snakes (rattlesnakes, cottonmouths, copperheads).
At a glance
| Generic name | CroFab |
|---|---|
| Sponsor | Instituto Bioclon S.A. de C.V. |
| Drug class | Antivenom (polyclonal antibody fragments) |
| Target | Crotalid venom toxins (phospholipase A2, serine proteases, metalloproteinases) |
| Modality | Biologic |
| Therapeutic area | Toxicology / Emergency Medicine |
| Phase | FDA-approved |
Mechanism of action
CroFab contains immunoglobulin fragments (Fab) derived from sheep immunized with crotalid snake venoms. These Fab fragments bind to and neutralize multiple venom components including phospholipase A2, serine proteases, and metalloproteinases, preventing their pathological effects on coagulation, hemolysis, and tissue damage. The drug is administered intravenously to treat envenomation by North American pit vipers.
Approved indications
- Envenomation by North American crotalid snakes (rattlesnakes, cottonmouths, copperheads)
Common side effects
- Hypersensitivity reactions
- Serum sickness
- Coagulopathy recurrence
Key clinical trials
- Optimal Dose of Antivenom for Daboia Siamensis Envenomings (PHASE2)
- The Efficacy of Crotaline Fab Antivenom for Copperhead Snake Envenomations (PHASE4)
- Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation
- Randomized, Double-Blind, Placebo-Controlled Study: CroFab® vs Placebo for Copperhead Snake Envenomation (PHASE4)
- A Comparison of Crotalinae Equine Immune F(ab)2 Antivenom (Anavip) and Crotalidae Polyvalent Immune Fab, (PHASE2)
- Phase 3 Multicenter Comparative Study to Confirm Safety and Effectiveness of the F(ab)2 Antivenom Anavip. (PHASE3)
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:
- CroFab CI brief — competitive landscape report
- CroFab updates RSS · CI watch RSS
- Instituto Bioclon S.A. de C.V. portfolio CI