PeptideTrace
ApprovedDirect Thrombin Inhibitor

Bivalirudin

Angiomax

A

Evidence Grade A — Regulatory approved. 1886 published studies. 92 registered clinical trials.

92 trials1,886 studiesUSEUCA

Licensed Indications

  • Acute Coronary Syndrome
  • Anticoagulation During Percutaneous Coronary Intervention
  • Heparin-Induced Thrombocytopenia

User Experience Reports

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Overview

Bivalirudin (sold as Angiomax) is a hospital blood thinner given through an IV drip during heart procedures such as coronary stenting. Originally inspired by the natural anticoagulant found in medicinal leeches, it is especially valuable for patients who cannot safely receive heparin. Its effects wear off predictably within about 25 minutes of stopping the infusion, giving doctors precise control.

Research Activity

1,886studies
Human 1607
Animal 25
In-vitro 60
Reviews 501

1,886 published studies: 1607 human, 25 animal, 60 in-vitro, 501 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
EMA-authorised(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUPrescription medicine (EU centralised authorisation)
CAPrescription drug

Summary

Bivalirudin is marketed as Angiomax (approved December 2000), with generic versions available. It is indicated for coronary interventions, particularly in patients with or at risk of heparin-induced thrombocytopenia (HIT) — a dangerous allergic reaction to heparin where the immune system attacks platelets.

The HORIZONS-AMI trial in heart attack patients showed bivalirudin reduced major bleeding by 40% compared to heparin plus a GPIIb/IIIa inhibitor. However, it was associated with a higher rate of early stent clotting (acute stent thrombosis), which has tempered enthusiasm. Bivalirudin's role has narrowed as radial artery access (which reduces bleeding) has become standard, but it remains the go-to anticoagulant when heparin cannot be used.

Mechanism of Action

Bivalirudin grabs thrombin — the key enzyme that converts fibrinogen into fibrin clots — at two separate points simultaneously, blocking both its active site and its fibrinogen-binding site. This dual grip provides powerful and specific anticoagulation. Crucially, thrombin slowly chews through the bivalirudin molecule itself, breaking free over about 25 minutes. This self-limiting mechanism means anticoagulation wears off predictably and quickly once the infusion stops — a significant safety advantage over heparin, which can be unpredictable and requires monitoring.

Research Summary

Bivalirudin's evidence comes from large cardiology trials involving thousands of patients. The HORIZONS-AMI trial showed a 40% reduction in major bleeding compared to heparin-based regimens in heart attack patients. However, it was also linked to a higher rate of early stent clotting, which tempered initial enthusiasm. The drug's clinical niche has narrowed over time. It was originally positioned as a safer alternative when used alongside powerful anti-platelet infusions, but as those infusions fell out of routine use, the bleeding advantage over heparin alone became less compelling. Today, bivalirudin is used primarily in patients with heparin-induced thrombocytopenia — a dangerous immune reaction to heparin — where a non-heparin anticoagulant is essential. No major new research programmes are active.

Clinical Trials

NCT01245725Phase IIIWithdrawn

Aggrastat Truncated Length Against Standard Therapies in Percutaneous Coronary Intervention

MedicureEndpoint: A composite incidence of death, myocardial infarction and urgent target vessel revascularization.
NCT07383155Phase IVNot Yet Recruiting

Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes

Shenyang Northern HospitalEndpoint: Net adverse clinical events (NACE) at 30 daysCompletion: 2028-12-31
NCT06861374N/ANot Yet Recruiting

Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy

First Affiliated Hospital Xi'an Jiaotong UniversityEndpoint: Composite of all-cause death or BARC type 3、5 bleedingCompletion: 2029-03-01
NCT06080074Phase IIRecruiting

Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System

Stanford UniversityEndpoint: Survival to 30 days, recovery, ventricular assist device implant or transplant in the absence of severe symptomatic stroke (primary device effectiveness)Completion: 2029-09-01
NCT06275555N/ARecruiting

Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

Xiaotong HouEndpoint: thrombotic complicationsCompletion: 2027-03-01
View all 92 trials on ClinicalTrials.gov →

Regulatory Timeline

2000
Regulatory

FDA ORIG 1

2001
Regulatory

FDA SUPPL 1

2001
Regulatory

FDA SUPPL 2

2001
Regulatory

FDA SUPPL 3

2002
Regulatory

FDA SUPPL 4

2004
Regulatory

FDA SUPPL 9

2004
Regulatory

EMA Marketing Authorisation

2005
Regulatory

FDA SUPPL 6

2005
Regulatory

FDA SUPPL 14

2005
Regulatory

FDA SUPPL 11

2010
Regulatory

FDA SUPPL 23

2012
Regulatory

FDA SUPPL 25

2012
Regulatory

FDA SUPPL 27

2013
Regulatory

FDA SUPPL 28

2013
Regulatory

FDA SUPPL 29

2013
Regulatory

FDA SUPPL 30

2014
Regulatory

FDA SUPPL 31

2015
Regulatory

FDA SUPPL 32

2015
Regulatory

FDA SUPPL 35

2016
Regulatory

FDA SUPPL 34

2016
Regulatory

FDA SUPPL 36

2016
Regulatory

FDA SUPPL 33

2016
Regulatory

FDA ORIG 1

2017
Regulatory

FDA ORIG 1

2017
Regulatory

FDA ORIG 1

2018
Regulatory

FDA ORIG 1

2018
Regulatory

FDA ORIG 1

2018
Regulatory

FDA ORIG 1

2018
Regulatory

FDA SUPPL 37

2019
Regulatory

FDA SUPPL 39

2019
Regulatory

FDA ORIG 1

2019
Regulatory

FDA SUPPL 3

2019
Regulatory

FDA SUPPL 1

2019
Regulatory

FDA SUPPL 5

2019
Regulatory

FDA SUPPL 1

2019
Regulatory

FDA SUPPL 2

2019
Regulatory

FDA ORIG 1

2021
Regulatory

Health Canada Market Authorisation

2021
Regulatory

FDA SUPPL 2

2021
Regulatory

FDA ORIG 1

2023
Regulatory

FDA SUPPL 2

2023
Regulatory

FDA SUPPL 3

2025
Regulatory

FDA SUPPL 2

2025
Regulatory

FDA SUPPL 7

2025
Regulatory

FDA SUPPL 5

Related Compounds

Exenatide

Approved
GLP-1 Receptor Agonist

Exenatide was the first GLP-1 receptor agonist approved anywhere, reaching the market as Byetta in April 2005. The once-weekly formulation Bydureon followed in 2012. Clinical trials showed blood sugar reductions (HbA1c) of 1.6–1.9% and modest weight loss of 2–4 kg. The EXSCEL cardiovascular outcomes trial, involving over 14,700 patients, showed a trend toward cardiovascular benefit but narrowly missed statistical significance. While exenatide was groundbreaking as the first in its class, it has been largely overtaken by newer GLP-1 treatments that offer greater efficacy, less frequent dosing, and proven cardiovascular benefits. It remains available and in clinical use, particularly in combination products.

Lixisenatide

Approved
GLP-1 Receptor Agonist

Lixisenatide was marketed as Adlyxin in the US (approved July 2016), though it has since been discontinued in the US market. The ELIXA cardiovascular trial, involving over 6,000 patients, was the first cardiovascular outcomes trial for any GLP-1 medication to report results. It showed a neutral cardiovascular profile — neither harmful nor beneficial — meeting safety requirements but not demonstrating the heart benefits later shown by semaglutide and liraglutide. Lixisenatide found its primary clinical role in combination with basal insulin, marketed as Soliqua (lixisenatide plus insulin glargine). This combination addresses both fasting blood sugar (via insulin) and post-meal spikes (via lixisenatide) in a single daily injection. As a standalone treatment, it has been largely superseded by more potent GLP-1 medications.

Pramlintide

Approved
Amylin Analogue

Pramlintide is marketed as Symlin (approved March 2005) and remains the only approved amylin-based treatment. It is used alongside mealtime insulin in both type 1 and type 2 diabetes. Clinical trials showed modest blood sugar improvements (HbA1c reductions of 0.2–0.6%) and approximately 2.3 kg of weight loss — less dramatic than GLP-1 treatments but meaningful as an add-on therapy. Symlin carries a boxed warning for severe hypoglycaemia, particularly when combined with insulin, and requires careful dose adjustment. Practical uptake has been limited by the need for separate injections at each meal alongside existing insulin injections. Despite its modest clinical impact, pramlintide remains the only medication that addresses the amylin deficiency in diabetes, filling a distinct biological role that GLP-1 treatments do not cover.