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Bivalirudin

Written by The Peptide Record editorialClinical review not yet completedLast reviewed 15 September 2026

Bivalirudin (Angiomax) is a real, FDA-approved synthetic peptide anticoagulant, derived from hirudin — the natural clot-blocking peptide in leech saliva — used during coronary angioplasty procedures.

On this page
  1. A leech-derived anticoagulant, re-engineered
  2. The approval and two pivotal trials
  3. Safety
  4. Current status

In brief

Should you care? Only relevant in the context of coronary angioplasty/stenting — a hospital-only anticoagulant with no wellness angle.

The short version

  • A 20-amino-acid synthetic peptide, engineered from hirudin, the natural anticoagulant in medicinal-leech saliva.
  • Approved December 2000; two major trials (REPLACE-2, then ACUITY) established its role, first in elective angioplasty, then in higher-risk acute coronary syndrome.
  • No boxed warning — its main risk is bleeding, lower than the heparin-based regimens it's often compared against.

A leech-derived anticoagulant, re-engineered

Bivalirudin is a synthetic 20-amino-acid peptide, a direct thrombin inhibitor engineered as an analog of hirudin, the natural anticoagulant peptide in the saliva of the medicinal leech (Hirudo medicinalis). It binds thrombin at two separate sites simultaneously, but unlike hirudin itself, thrombin slowly cleaves bivalirudin over time, restoring its own activity — giving bivalirudin a shorter, more controllable anticoagulant effect than the natural molecule it's based on.

The approval and two pivotal trials

The FDA approved bivalirudin (as Angiomax) in December 2000 for use during coronary angioplasty, alongside aspirin. Two major trials shaped how it's used: REPLACE-2 (Lincoff et al., JAMA 2003, PMID 12588269), 6,010 patients undergoing elective/urgent angioplasty, found bivalirudin with only provisional (as-needed) GPIIb/IIIa blockade was non-inferior to heparin with planned GPIIb/IIIa blockade, with significantly less bleeding. Later, ACUITY (Stone et al., N Engl J Med 2006, PMID 17124018), 13,819 patients with moderate-to-high-risk acute coronary syndromes, found bivalirudin alone suppressed ischemic events about as well as heparin plus a GPIIb/IIIa inhibitor, while significantly lowering major bleeding — the trial that established bivalirudin-alone as a genuine treatment strategy in higher-risk, more urgent cases, not just elective procedures.

Safety

Bivalirudin carries no boxed warning. Its main risk, as with any anticoagulant, is bleeding — consistently lower across its pivotal trials than the heparin-plus-GPIIb/IIIa-inhibitor regimens it was tested against. It also carries a labeled risk of thrombus formation, including fatal cases, specifically in patients undergoing coronary brachytherapy (a radiation-based procedure).

Current status

Generic bivalirudin has been available since 2015 (Hospira received the first ANDA approval), alongside multiple other generic manufacturers now supplying the US market. Hospital cath-lab-only use, no wellness or grey-market presence.

References

  1. Lincoff AM, Bittl JA, Harrington RA, et al., "Bivalirudin and Provisional Glycoprotein IIb/IIIa Blockade Compared With Heparin and Planned Glycoprotein IIb/IIIa Blockade During Percutaneous Coronary Intervention: REPLACE-2 Randomized Trial," JAMA 2003;289(7):853-863, PMID 12588269.
  2. Stone GW, McLaurin BT, Cox DA, et al. (ACUITY Investigators), "Bivalirudin for Patients with Acute Coronary Syndromes," N Engl J Med 2006;355(21):2203-2216, PMID 17124018, DOI: 10.1056/NEJMoa062437.
  3. FDA approval history for Angiomax (bivalirudin), December 2000. Hospira generic ANDA approval, July 2015.