PRAXBIND (idarucizumab)
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-10-16
- Patent Cliff
- 2022
- 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.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03343704 results posted | 1321-0019 | Ph 3 | completed | This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding |
| NCT02815670 results posted | 1321.7 2015-002177-37 | Ph 3 | completed | Reversal Dabigatran Anticoagulant Effect With Idarucizumab |
| NCT03086356 results posted | 1321.6 | Ph 1 | completed | Study to Investigate the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Idarucizumab in Chinese Healthy Male and Female Volunteers Who Had Taken Dabigatran Etexilate and Whose Plasma Concentrations of Dabigatran Were at or Close to Steady State |
| NCT02831660 results posted | 1321.14 | Ph 3 | completed | CU Programme of Idarucizumab for Japanese Patients |
| NCT02104947 results posted | 1321.3 2013-004813-41 | Ph 3 | completed | Reversal of Dabigatran Anticoagulant Effect With Idarucizumab |
| NCT02028780 results posted | 1321.5 | Ph 1 | completed | Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects |
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
Indications & Usage
FDA Label (PDF)PRAXBIND is indicated for the treatment of Life-Threatening Bleeding; Uncontrolled Bleeding.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment