PRAXBIND
Praxbind (idarucizumab) is a humanized monoclonal antibody fragment indicated for patients treated with the anticoagulant Pradaxa (dabigatran). It is used when the reversal of dabigatran's effects is required for emergency surgery or urgent procedures. Additionally, it is indicated for patients experiencing life-threatening or uncontrolled bleeding. The drug serves as a specific reversal agent to counteract the anticoagulant properties of dabigatran in these critical situations.
How PRAXBIND Works
Idarucizumab acts as a specific reversal agent by binding to dabigatran and its acylglucuronide metabolites. This humanized monoclonal antibody fragment has a higher affinity for dabigatran than dabigatran has for thrombin. By binding to the drug and its metabolites, idarucizumab neutralizes their anticoagulant effect. This mechanism allows for the restoration of normal coagulation by preventing dabigatran from interacting with thrombin.
Details
- Status
- Prescription
- First Approved
- 2015-10-16
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PRAXBIND Approval History
What PRAXBIND Treats
2 indicationsPRAXBIND is approved for 2 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Life-Threatening Bleeding
- Uncontrolled Bleeding
PRAXBIND Target & Pathway
ProTarget
The central enzyme in blood coagulation that converts fibrinogen to fibrin, forming blood clots. Direct thrombin inhibitors prevent clot formation and are used to prevent stroke and treat blood clots.
PRAXBIND Competitors
Pro6 other drugs also target THROMBIN. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (THROMBIN). Earlier expiry dates signal biosimilar/generic opportunities.
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.
PRAXBIND FDA Label Details
ProIndications & Usage
FDA Label (PDF)PRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding PRAXBIND is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa ® when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.