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Angiomax

(Bivalirudin)

ApprovedSmall molecule

BBaxter Healthcare Corporation

Bivalirudin is used to prevent blood clots during heart procedures, particularly in patients undergoing angioplasty or other interventions to treat coronary artery disease. It works by thinning the blood to reduce the risk of dangerous clot formation during these medical procedures.[2] Angiomax is currently approved and in use across 18 indications[4].[1]

Angiomax is one of 359 small molecule programs targeting Thrombotic Disease. It is currently in Approved.

18

Indications

53

Total Trials

7

Active Trials

358

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

8

Patents

Pipeline

Status by Indication[4][1]

Indication

Thrombotic DiseaseActive, not recruiting

Aortic StenosisApproved

Abnormality of Blood and Blood-Forming TissuesApproved

Coronary Artery DiseaseApproved

Subarachnoid HemorrhageApproved

Deep Vein ThrombosisApproved

Recurrent ThrombophlebitisActive, not recruiting

Intermediate Coronary SyndromeActive, not recruiting

COVID-19Active, not recruiting

Heart FailureRecruiting

Thrombotic DiseaseApproved

Active, not recruiting

Aortic StenosisApproved

Approved

Abnormality of Blood and Blood-Forming TissuesApproved

Approved

Coronary Artery DiseaseApproved

Approved

Subarachnoid HemorrhageApproved

Approved

Deep Vein ThrombosisApproved

Approved

Recurrent ThrombophlebitisApproved

Active, not recruiting

Intermediate Coronary SyndromeApproved

Active, not recruiting

COVID-19Preclinical

Active, not recruiting

Heart FailurePhase 2

Recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Angiomax

BBaxter Healthcare Corporation

Stivarga

Aimovig

Aldactone

Nexavar

Calciferol

Jazz Pharmaceuticals

Activella

Tricor

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Benadryl

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Extracorporeal Membrane Oxygenation

NCT06275555

Q1 2029

N/ANot yet recruiting

Prolonged

NCT06861374

Q3 2029

Phase 2Recruiting

Heart Failure

NCT06080074

Clinical

Trials by Indication[1]

Percutaneous Coronary Intervention4 trials

How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention

Completed·LLiverpool Heart and Chest Hospital NHS Foundation Trust·Phase 4·NCT01519518·1,829 enrolled

Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

Unknown status·TThe First Affiliated Hospital of Dalian Medical University·Phase 4·NCT04046029·240 enrolled

Un-fractionated Heparin Versus Bivalirudin During Percutaneous Coronary Interventions (PCI) (ISAR-REACT-3)

Completed·DDeutsches Herzzentrum Muenchen·Phase 4·NCT00262054·4,570 enrolled

Show 1 more trial

Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention

Terminated·SStony Brook University·Phase 4·NCT01464671·260 enrolled

Anticoagulation3 trials

Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI

Completed·—·Phase 4·NCT03664180·2,989 enrolled

Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

Recruiting·—··NCT03532399·30 enrolled

RIAPRE - Non-interventional Registry of Anticoagulation Treatment (BI-006-IT)

Withdrawn·NNycomed··NCT00317343

Extracorporeal Membrane Oxygenation3 trials

Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

Recruiting·XXiaotong Hou·N/A·NCT06275555·154 enrolled

Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation

Unknown status·LLegacy Health System·Phase 4·NCT03965208·34 enrolled

BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

Recruiting·SSydney Local Health District·Phase 2·NCT05959252·80 enrolled

Acute Myocardial Infarction3 trials

Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction

Completed·CCardiovascular Research Foundation, New York·Phase 3·NCT00433966·3,602 enrolled

BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.

Completed·SShenyang Northern Hospital·Phase 4·NCT01696110·2,194 enrolled

Bivalirudin in Acute Myocardial Infarction

Unknown status·SShenzhen Salubris Pharmaceuticals Co., Ltd.·Phase 3·NCT02897037·380 enrolled

Thrombocytopenia2 trials

Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients

Withdrawn· Novartis logo

Novartis·Phase 4·NCT00759083

Anticoagulant Therapy With Bivalirudin in the Performance of Percutaneous Coronary Intervention in Patients With Heparin-Induced Thrombocytopenia (AT BAT, First Inning)

Completed· Novartis logo

Novartis·Phase 3·NCT00043940·50 enrolled

31 more indications

Prolonged2 trials

Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy

Not yet recruiting·FFirst Affiliated Hospital Xi'an Jiaotong University·N/A·NCT06861374·2,400 enrolled

Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI

Completed·SShenyang Northern Hospital·N/A·NCT03822975·6,016 enrolled

Bleeding2 trials

EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding

Unknown status·LLaval University·Phase 4·NCT01084993·2,000 enrolled

Novel Approaches in Preventing and Limiting Events III Trial (NAPLES III): Bivalirudin in High-risk Bleeding Patients

Completed·CClinica Mediterranea·Phase 3·NCT01465503·837 enrolled

Myocardial Infarction2 trials

Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction

Unknown status·DDeutsches Herzzentrum Muenchen·Phase 4·NCT00976092·548 enrolled

Bivalirudin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction

Unknown status·TThe First Affiliated Hospital of Dalian Medical University·Phase 4·NCT03882775·240 enrolled

COVID-192 trials

Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

Completed·UUniversity Magna Graecia·N/A·NCT05334654·58 enrolled

Anticoagulation in Patients Suffering From COVID-19 Disease The ANTI-CO Trial

Unknown status·HHamad Medical Corporation·Phase 4·NCT04445935·100 enrolled

Acute Coronary Syndrome2 trials

Randomized Comparison of Abciximab Plus Heparin With Bivalirudin in Acute Coronary Syndrome

Completed·DDeutsches Herzzentrum Muenchen·Phase 4·NCT00373451·1,721 enrolled

European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial

Completed· Novartis logo

Novartis·Phase 3·NCT01087723·2,198 enrolled

Atrial Appendage1 trial

Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT04195997·100 enrolled

Infusion1 trial

Bivalirudin Infusion for Ventricular Infarction Limitation

Terminated· Novartis logo

Novartis·Phase 3·NCT02565147·78 enrolled

Microcirculation1 trial

A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.

Recruiting·PPeking University First Hospital·Phase 4·NCT05984537·70 enrolled

High Risk Patients1 trial

ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding

Completed·HHaEmek Medical Center, Israel·Phase 3·NCT00616460·100 enrolled

Coronary Revascularization1 trial

Comparison of Anticoagulation for All-comers Undergoing Percutaneous Coronary Revascularization Trial

Terminated·KKaiser Permanente·Phase 3·NCT02448550·250 enrolled

PCAB1 trial

Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB

Completed· Novartis logo

Novartis·Phase 3·NCT00073593·150 enrolled

Anticoagulant1 trial

Bivalirudin as a Procedural Anticoagulant in Pediatrics

Completed· Novartis logo

Novartis·Phase 2·NCT00503126·110 enrolled

Heart Disease1 trial

Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Unknown status·—·Phase 4·NCT02787317·1,770 enrolled

Cardiopulmonary Bypass1 trial

Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)

Completed· Novartis logo

Novartis·Phase 3·NCT00079586·150 enrolled

Percutaneous Coronary Intervention (PCI)1 trial

Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)

Unknown status·QQian Gong·Phase 2·NCT03567408·200 enrolled

Coronary Microvascular Dysfunction1 trial

A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction

Active, not recruiting·NNYU Langone Health·N/A·NCT03537586·206 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery After PPCI of STEMI

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University·N/A·NCT04475835·100 enrolled

Fibrinolysis1 trial

Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography

Completed·NNYU Langone Health·Phase 4·NCT01848899·100 enrolled

Antiplatelet Therapy1 trial

Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART

Completed·UUppsala University·Phase 4·NCT02311231·6,012 enrolled

Pediatric1 trial

Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT03318393·30 enrolled

Antithrombotic1 trial

Antithrombotic Regimens and Outcome

Completed·—·Phase 4·NCT00448461·850 enrolled

STEMI1 trial

Bivalirudin in Late PCI for Oatients With STEMI

Unknown status·SSecond Xiangya Hospital of Central South University·Phase 4·NCT04185077·1,200 enrolled

MPR1 trial

ImproveR International (BI-001-IM)

Completed·NNycomed··NCT00290849·4,000 enrolled

Aneurysm1 trial

Efficacy and Safety of Bivalirudin Versus Heparin During Coil Embolization in Patients With Ruptured Intracranial Aneurysms

Unknown status·—·Phase 3·NCT04532333·236 enrolled

ECMO1 trial

Bivalirudin vs Heparin in ECMO Patients

Withdrawn·JJohns Hopkins University·Phase 1·NCT03707418

Trial1 trial

ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

Terminated· Novartis logo

Novartis·Phase 3·NCT01913483·732 enrolled

Necrosis1 trial

Bivalirudin Plus Stenting in Long Lesion to Avoid Periprocedural Myocardial Necrosis Trial

Unknown status·UUniversity of Roma La Sapienza·Phase 3·NCT01555658·204 enrolled

Efficacy and Safety1 trial

A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI

Terminated·RRegado Biosciences, Inc.·Phase 3·NCT01848106·3,232 enrolled

Randomized1 trial

Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH

Completed· Novartis logo

Novartis·Phase 3·NCT01651780·803 enrolled

Heart Failure1 trial

Multicenter Trial to Evaluate the Safety and Effectiveness of the Cardiohelp System for up to 30 Days of Support in Children With Severe Cardiac Failure

Recruiting·SStanford University·Phase 2·NCT06080074·50 enrolled

Unspecified3 trials

The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids

Completed·—·Phase 1·NCT00812370·18 enrolled

Reduce Bolus Injection of Bivalirudin

Completed·—·Phase 4·NCT03588611·204 enrolled

Simplified Anti-Thrombotic Therapy for FFR

Completed·OOdessa Heart Institute·N/A·NCT02384070·300 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 15, 2000

ANGIOMAX

NDA NDA020873

Dec 21, 2017

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

NDA NDA208374

Jul 25, 2019

ANGIOMAX RTU

NDA NDA211215

Sources

References

[1]
ClinicalTrials.gov — 53 trial records for Bivalirudin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Angiomax drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bivalirudin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bivalirudin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA211215). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Angiomax. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Baxter Healthcare Corporation company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Thrombin Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBaxter Healthcare Corporation

Patent Landscape[6]

Patent Cliff

Jul 27, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7582727Jul 27, 2028

7598343Jul 27, 2028

7582727*PEDJan 27, 2029

7598343*PEDJan 27, 2029

11992514May 20, 2039

3 more patents

12472224May 20, 2039

11918622May 20, 2039

11903993May 20, 2039

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