BIVALIRUDIN
Bivalirudin is an anticoagulant used for patients undergoing percutaneous coronary intervention (PCI). It helps patients manage the risk of blood clots during these procedures, including those who have heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS). This medication works by preventing the thrombotic process through direct inhibition of thrombin.
How BIVALIRUDIN Works
The drug works by binding to both the catalytic site and the anion-binding exosite of thrombin, which prevents the enzyme from activating platelets and converting fibrinogen into fibrin. This inhibits the formation of a cross-linked framework that stabilizes blood clots. Because thrombin slowly cleaves the drug, the binding is reversible and allows for the eventual recovery of thrombin's active site functions.
Details
- Status
- Prescription
- First Approved
- 2015-07-14
- Routes
- INTRAVENOUS, INJECTION
- Dosage Forms
- INJECTABLE
Companies
BIVALIRUDIN Approval History
What BIVALIRUDIN Treats
2 indicationsBIVALIRUDIN is approved for 2 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Heparin-Induced Thrombocytopenia
- Heparin-Induced Thrombocytopenia and Thrombosis Syndrome
BIVALIRUDIN 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.
BIVALIRUDIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
21 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05959252 BLUSH | 2023/ETH00443 | Ph 2 | recruiting | BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation |
| NCT06080074 TROLLEY | 72467 | Ph 2 | recruiting | Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System |
| NCT05984537 PCI | ZHENG Bo. | Ph 4 | recruiting | A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation. |
| NCT03664180 RIGHT | 2018024X BJUHFRIGHT201802 | Ph 4 | completed | Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI |
| NCT03318393 results posted | 072017-045 | Ph 4 | completed | Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO |
| NCT03588611 | RE-20180628 | Ph 4 | completed | Reduce Bolus Injection of Bivalirudin |
| NCT00759083 | TMC-BIV-07-02 | Ph 4 | withdrawn | Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients |
| NCT02565147 BIVAL results posted | MDCO-BIV-12-02 2012-002314-39 | Ph 3 | terminated | Bivalirudin Infusion for Ventricular Infarction Limitation |
| NCT02448550 CALIFORNIA | KP-RRC-CE1 | Ph 3 | terminated | Comparison of Anticoagulation for All-comers Undergoing Percutaneous Coronary Revascularization Trial |
| NCT01913483 ENDOMAX results posted | MDCO-BIV-12-03 | Ph 3 | terminated | ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial |
| NCT02311231 VALIDATE | EudraCT nr: 2012-005260-10 | Ph 4 | completed | Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART |
| NCT01651780 BRAVO 2/3 results posted | TMC-BIV-11-02 2012-000632-26 | Ph 3 | completed | Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH |
| NCT00812370 UNBLOCK | 3070850 | Ph 1 | completed | The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids |
| NCT01848899 results posted | 12-02409 | Ph 4 | completed | Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography |
| NCT01087723 EUROMAX results posted | TMC-BIV-08-03 | Ph 3 | completed | European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial |
| NCT00616460 ACRIPAB | 0124-07-EMC | Ph 3 | completed | ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding |
| NCT01519518 HEAT-PPCI results posted | 923 | Ph 4 | completed | How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention |
| NCT01464671 STATUS PCI | 119778 (IRB ID) | Ph 4 | terminated | Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention |
| NCT01848106 Regulate | REG1-CLIN310 2013-001384-23 | Ph 3 | terminated | A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI |
| NCT01696110 BRIGHT | SYNH20120001 2011BAI11B07 | Ph 4 | completed | BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial. |
| NCT01465503 NAPLESIII | NCTCM02 | Ph 3 | completed | Novel Approaches in Preventing and Limiting Events III Trial (NAPLES III): Bivalirudin in High-risk Bleeding Patients |
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.
BIVALIRUDIN FDA Label Details
Indications & Usage
FDA Label (PDF)BIVALIRUDIN is indicated for the treatment of Heparin-Induced Thrombocytopenia; Heparin-Induced Thrombocytopenia and Thrombosis Syndrome.
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ANGIOMAX
Full clinical data, patents, trials, and competitive landscape for bivalirudin.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.