Peptide LibraryBivalirudin
Also known as: Angiomax, Hirulog
Bivalirudin (also called Angiomax or Hirulog) is an FDA-approved direct thrombin inhibitor. Bivalirudin is a synthetic twenty-amino-acid peptide modelled on hirudin, the anticoagulant of the medicinal leech. It is bivalent: one end occupies the catalytic site of thrombin while the other binds exosite 1, the fibrinogen recognition site, so it blocks both the enzymatic activity and the substrate docking that thrombin needs.
For research use only.
Key Facts
- CAS
- 128270-60-0
- Molecular Weight (MW)
- 2180.3 g/mol
- Half-life
- About 25 minutes with normal kidney function; longer with kidney impairment (3.5 hours in dialysis patients)
- FDA status
- Approved
- Evidence level
- FDA Approved
- Human dose established
- Yes
- Administration Route
- Intravenous
- Frequency
- Intravenous bolus followed by continuous infusion
- Last updated
- Nov 7, 2026
- Reviewed
- Nov 7, 2026
- Targets
- Thrombin (factor IIa)
Research summary
FDA-approved bivalent direct thrombin inhibitor used with PCI. IV bolus plus infusion per labeled weight-based regimen; hospital use only.
Research evidence
- Regulatory review (FDA label)2 reviewed sources
- Controlled human trialsNone in reviewed sources
- Early or uncontrolled human studiesNone in reviewed sources
- Lab & animal studiesNone in reviewed sources
How it works
Each step shows whether the sources Peptide Library has reviewed include that kind of research. Counts are reviewed sources, not every study ever published. Reviews and programme summaries that describe human use are shown as "reported", not as trials, and registered trials without published results are listed but not counted. A higher step means research has progressed further; it does not mean a compound works better or is safer. Compounds whose evidence has not been reviewed yet show "Not reviewed" instead of a guess.
Peptide Library's Bivalirudin profile summarises 5 cited studies listed in the Science section, the compound's regulatory status, and research-protocol parameters reported for it. It is a research reference, not medical advice.
Bivalirudin dosage evidence
Bivalirudin has an FDA-approved human dosage as an intravenous anticoagulant for adults undergoing percutaneous coronary intervention (PCI), including people with heparin-induced thrombocytopenia. The label's recommended dose is a 0.75 mg/kg intravenous bolus followed immediately by an infusion of 1.75 mg/kg per hour for the duration of the procedure, given with aspirin.
| Human dosing established | Yes |
|---|---|
| Route | Intravenous |
| Frequency | Intravenous bolus followed by continuous infusion |
| Duration studied | For the duration of the procedure; up to 4 hours afterwards may be considered in STEMI |
| Half-life | About 25 minutes with normal kidney function; longer with kidney impairment (3.5 hours in dialysis patients) |
| Evidence level | FDA Approved |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — anticoagulation during percutaneous coronary interventionFDA-approved label · FDA prescribing information | Adults undergoing PCI, including those with heparin-induced thrombocytopenia (HIT/HITTS), receiving aspirin | 0.75 mg/kg bolus, then 1.75 mg/kg/hour; an extra 0.3 mg/kg bolus if the activated clotting time 5 minutes later calls for it | Intravenous | Bolus, then continuous infusion | For the procedure; extending the infusion up to 4 hours after PCI should be considered in STEMI | Anticoagulation during PCI | Bivalirudin for injection (Sandoz, NDA 020873) — FDA prescribing information, DailyMed |
| FDA label — kidney impairmentFDA-approved label · FDA prescribing information | Adults undergoing PCI with creatinine clearance below 30 mL/min, or on hemodialysis | Same bolus; infusion reduced to 1 mg/kg/hour (creatinine clearance below 30 mL/min) or 0.25 mg/kg/hour (hemodialysis) | Intravenous | Bolus, then continuous infusion | For the procedure | Dose adjustment with anticoagulant monitoring | Bivalirudin for injection (Sandoz, NDA 020873) — FDA prescribing information, DailyMed |
Where sources disagree
- Bivalirudin is a direct thrombin inhibitor used during PCI. The label warns that it increases the risk of bleeding, that acute stent thrombosis was more frequent in STEMI patients undergoing primary PCI, and that thrombus formation, including fatal cases, was more likely during gamma brachytherapy. There is no known antidote.
- Overdoses reported in trials and after marketing were often due to not reducing the infusion in people with kidney impairment, according to the label. Safety and effectiveness in children have not been established.
- The label describes a 250 mg vial that is reconstituted and then diluted before intravenous use.
Handling & administration
- Reconstitution Guide
- Reconstitute with sterile water for injection per package insert
- Concentration Example
- 250 mg vial reconstituted to 5 mg/mL
- Timing Notes
- Administered intravenously during percutaneous coronary intervention
- Expected Onset
- Immediate anticoagulation effect
Sequence & molecular data
| Molecular formula | C98H138N24O33 |
|---|---|
| Molecular weight | 2180.3 g/mol |
| CAS number | 128270-60-0 |
| Half-life | ~25 minutes (normal renal function) |
| Appearance | Lyophilized powder for IV solution |
| Formulation | Lyophilized Powder |
| PubChem CID | 16129704 |
| FDA UNII | TN9BEX005G |
| DrugBank | DB00006 |
Identifiers link to the public PubChem, FDA Substance Registration (UNII), ChEMBL and DrugBank records for the same entity.
Science
Mechanism of Action
Bivalirudin is a synthetic twenty-amino-acid peptide modelled on hirudin, the anticoagulant of the medicinal leech. It is bivalent: one end occupies the catalytic site of thrombin while the other binds exosite 1, the fibrinogen recognition site, so it blocks both the enzymatic activity and the substrate docking that thrombin needs. Unlike heparin it does not require antithrombin as a cofactor and it inhibits clot-bound as well as circulating thrombin. Its action is self-limiting: thrombin slowly cleaves the bound peptide, restoring activity, which gives a short and predictable offset without a reversal agent and makes it useful where heparin-induced thrombocytopenia is a concern.
Origin
Synthetic 20-amino-acid hirudin analog.
Targets
Studies
- Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation
- Bivalirudin in Extracorporeal Membrane Oxygenation
- Is it time to switch to bivalirudin for ECMO anticoagulation?
- Bivalirudin in pediatric extracorporeal membrane oxygenation
- Role of Bivalirudin for Anticoagulation in Adult Perioperative Cardiothoracic Practice
Research statistics
1,713 PubMed publications · 51.7% human clinical research · 69 registered trials
Counts of published research through 2026-11-01, not evidence that it works. Publications by year, study types and trials · How publications are counted
Regulatory & research status
Bivalirudin is an FDA-approved product for specific labelled indications. Approval does not extend to the research contexts described on this page, and approved products are prescription medicines.
| FDA status | Approved |
|---|---|
| Availability | Prescription-Only |
| WADA (sport) | Permitted |
| Library classification | FDA-Approved |
How FDA approval, compounding and research-only status differ
Benefits
Bivalirudin side effects
The effects below are drawn from Bivalirudin's prescribing information, which lists the full adverse-reaction data.
Side Effects
- Bleeding
- Back pain
- Nausea
- Hypotension
Storage & stability
This compound is not supplied as a powder to be mixed, so the freeze-dried powder and reconstitution handling described for research peptides does not apply. Storage conditions are product-specific: follow the label or packaging of the product itself.
Bivalirudin: frequently asked questions
What is Bivalirudin?
FDA-approved bivalent direct thrombin inhibitor used with PCI. IV bolus plus infusion per labeled weight-based regimen; hospital use only.
How does Bivalirudin work?
Bivalirudin is a synthetic twenty-amino-acid peptide modelled on hirudin, the anticoagulant of the medicinal leech. It is bivalent: one end occupies the catalytic site of thrombin while the other binds exosite 1, the fibrinogen recognition site, so it blocks both the enzymatic activity and the substrate docking that thrombin needs.
Is Bivalirudin FDA approved?
Yes. Bivalirudin is approved by the FDA, and approved products are prescription medicines. Approval is always for specific indications studied in clinical trials, so an approved status does not mean the compound is approved for every use it is discussed for. Research-chemical material sold under the same name is not the approved product.
What is the half-life of Bivalirudin?
Reported half-life for Bivalirudin is ~25 minutes (normal renal function). Half-life describes how long the compound persists in circulation, not how long any effect lasts, and published figures vary with route of administration, formulation and the population studied.
Is Bivalirudin banned in sport?
Bivalirudin is recorded here as permitted in sport. Anti-doping status is revised annually, so athletes subject to testing should confirm against the current WADA Prohibited List before use.
What peptides are similar to Bivalirudin?
Compounds most often compared with Bivalirudin include Abaloparatide and Teriparatide. They are grouped by shared mechanism or research area rather than by equivalence, and their regulatory status and evidence base differ.
References
- FDA label — AngiomaxExternal reference
- Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation — Pediatr Crit Care Med, 2025External reference
- Bivalirudin in Extracorporeal Membrane Oxygenation — J Cardiovasc Pharmacol, 2024External reference
- Is it time to switch to bivalirudin for ECMO anticoagulation? — Front Med (Lausanne), 2023External reference
- Bivalirudin in pediatric extracorporeal membrane oxygenation — Curr Opin Pediatr, 2022External reference
- Role of Bivalirudin for Anticoagulation in Adult Perioperative Cardiothoracic Practice — J Cardiothorac Vasc Anesth, 2020External reference
Related research, comparisons & guides
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Compiled by Peptide Library Editorial · Reviewed Aug 30, 2026 · Updated Nov 7, 2026 · Version 2
This Bivalirudin profile is compiled from published literature (5 cited studies linked above), public regulatory records and chemical registries. It describes what research reports; it is not medical advice, and nothing here is a dosing recommendation for humans. Peptide Library does not sell peptides. Editorial policy · How profiles are compiled · Report an error
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