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Data updated: Jun 28, 2026

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE (bivalirudin) · Baxter

Cardiovascular Approved 2017-12-21

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE is FDA-approved to treat 2 conditions (same as BIVALIRUDIN).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Discontinued
First Approved
2017-12-21
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Baxter
Active Ingredient: BIVALIRUDIN

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2017 to 2021
Jan 2021 SUPPL
Label · Labeling
FDA Letter Label
Dec 2017 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What BIVALIRUDIN IN 0.9% SODIUM CHLORIDE Treats

2 indications

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Heparin-Induced Thrombocytopenia
  • Heparin-Induced Thrombocytopenia and Thrombosis Syndrome

Same approved indications as BIVALIRUDIN (same active ingredient).

Source: FDA Label
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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NCT00759083 TMC-BIV-07-02 Ph 4 withdrawn Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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 IN 0.9% SODIUM CHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE is FDA-approved to treat 2 conditions — same approved indications as BIVALIRUDIN.

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Data Sources

FDA Approval: NDA208374 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.