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Drug

Bivalirudin

Approved medicine
ClassThrombin inhibitorResearchOngoing clinical research

Also known as Angiomax, Bivalirudina, Bivalirudinum.

RxNorm60819ChEMBLCHEMBL5314348ATCB01AE06UNIITN9BEX005G
6
Active clinical trials
Prothrombin
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-08-10Results expected Q3 2027 · ClinicalTrials.gov

BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO)

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled Trial

Clinical trial2026-04-06Results expected Q4 2026 · ClinicalTrials.gov

A Study on the Impact of Bivalirudin Usage During Percutaneous Coronary Intervention for High-risk Plaques in the Coronary Artery on Post Percutaneous Coronary Intervention Coronary Microcirculation.

Clinical trial2025-12-01Primary completion · ClinicalTrials.gov

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

Clinical trial2025-06-30Primary completion · ClinicalTrials.gov

Bivalirudin Plus High-Dose Infusion Versus Heparin Monotherapy in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention After Fibrinolysis: a Randomized Trial

Clinical trial2025-03-06Results expected Q1 2028 · ClinicalTrials.gov

Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial

Clinical trial2023-05-06Completed · ClinicalTrials.gov

Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation

Clinical trial2023-01-31Results posted · ClinicalTrials.gov

Study on Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery for Acute ST-segment Elevation Myocardial Infarction After Emergency Percutaneous Coronary Intervention

Clinical trial2022-12-01Primary completion · ClinicalTrials.gov

Randomized Comparison of Anticoagulation After Primary Percutaneous Coronary Intervention Using Enoxaparin, ACT Guided Unfractionated Heparin or Bivalirudin Prolongation vs. no Anticoagulation To Improve Clinical Outcome

Clinical trial2022-11-23Completed · ClinicalTrials.gov

Bivalirudin Versus Enoxaparin for Anticoagulation in Critically Ill COVID-19 Patients: a Pilot Randomized Controlled Trial

Clinical trial2022-07-30Completed · ClinicalTrials.gov

Drug Safety Update: Bivalirudin: risks associated with incorrect dose

Regulatory2014-12-11MHRA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Bivalirudin
Aliases & brands
AngiomaxBivalirudinaBivalirudinum
RxNorm CUI
60819
ChEMBL ID
CHEMBL5314348
ATC codes
B01AE06
UNII
TN9BEX005G
Primary mechanism
Thrombin inhibitor
Regulatory jurisdictions
mhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Prothrombin
F2 · P00734
INHIBITORThrombin inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
MHRA
Total events
1
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Bivalirudin: risks associated with incorrect dose
Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

50 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
50
registered trials across all phases
LATEST COMPLETION 2023
6
Active studies
5
Recruiting
44
Late-stage (III+)
23
Completed
21
Discontinued
PHASE DISTRIBUTIONn = 50
Phase 12Phase 24Phase 315Phase 422Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Study on the Impact of Bivalirudin Usage During Percutaneous Coronary Intervention for High-risk Plaques in the Coronary Artery on Post Percutaneous Coronary Intervention Coronary Microcirculation.

RecruitingPH IVPeking University First Hospitaln=702026

Randomized Comparison of Anticoagulation After Primary Percutaneous Coronary Intervention Using Enoxaparin, ACT Guided Unfractionated Heparin or Bivalirudin Prolongation vs. no Anticoagulation To Improve Clinical Outcome

CompletedPH IVKey trialBeijing Anzhen Hospitaln=2,9892022

Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation

CompletedPH IVUniversity of Texas Southwestern Medical Centern=302021

Bivalirudin vs Heparin in Elderly Patients With Acute Coronary Syndrome Undergoing Elective Percutaneous Coronary Intervention

Unknown statusPH IVThe First Affiliated Hospital of Dalian Medical Universityn=2402021

Multi-center Application of Bivalirudin in High-risk Bleeding Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Left Atrial Appendage Occlusion

Unknown statusPH IVShanghai Zhongshan Hospitaln=1002021

Recent completions

Trials that read out recently, adding to the completed evidence base.

Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial

CompletedN/AKey trialShenyang Northern Hospitaln=6,0162023

Randomized Comparison of Anticoagulation After Primary Percutaneous Coronary Intervention Using Enoxaparin, ACT Guided Unfractionated Heparin or Bivalirudin Prolongation vs. no Anticoagulation To Improve Clinical Outcome

CompletedPH IVKey trialBeijing Anzhen Hospitaln=2,9892022

Bivalirudin Versus Enoxaparin for Anticoagulation in Critically Ill COVID-19 Patients: a Pilot Randomized Controlled Trial

CompletedN/AUniversity Magna Graecian=582022

Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation

CompletedPH IVUniversity of Texas Southwestern Medical Centern=302021

The Noninferiority and Safety of Bivalirudin Between REDUCEd and Standard BOLUSin Percutaneous Coronary Intervention Patients Stratified by Renal Function

CompletedPH IVHan Yaling, MDn=2042021

Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the SWEDEHEART Platform

CompletedPH IVKey trialUppsala Universityn=6,0122017
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.