Bivalirudin Legal Status: Approval, Research Use, and Regulatory Notes
FDA-approved for use as an anticoagulant in patients undergoing PCI and for patients with or at risk of HIT undergoing PCI. Available by prescription for hospital use. Marketed as Angiomax by The Medicines Company. Generic versions available.
Direct Answer
Bivalirudin (Angiomax) is FDA-approved as an anticoagulant for PCI with Phase 3 data from the HORIZONS-AMI and ACUITY trials showing comparable efficacy to heparin plus GP IIb/IIIa inhibitors with significantly reduced bleeding risk. Its direct thrombin inhibition with predictable pharmacokinetics makes it a preferred anticoagulant in specific interventional cardiology settings.
- Evidence grade
- Level A
- Research status
- FDA Approved
- Category
- Healing & Recovery
- Best for
- PCI anticoagulation, direct thrombin inhibitor pharmacology, reduced-bleeding anticoagulation research
Legal and Regulatory Status
FDA-approved for use as an anticoagulant in patients undergoing PCI and for patients with or at risk of HIT undergoing PCI. Available by prescription for hospital use. Marketed as Angiomax by The Medicines Company. Generic versions available.
Approval Stage
Bivalirudin is listed as FDA Approved. Approved uses, if any, are indication-specific and do not automatically apply to other claims.
Compliance Notes
- Renal dose adjustment required - predominantly cleared renally
- Increased stent thrombosis risk if infusion stopped abruptly
- No specific reversal agent available
- Use caution with concomitant antiplatelet agents
Evidence Page
For the complete evidence review, see the main Bivalirudin guide linked below.
Evidence Snapshot
| Evidence grade | Level A |
|---|---|
| Research status | FDA Approved |
| Best supported outcomes | PCI Anticoagulation (Level A), Reduced Major Bleeding (Level A), and Acute Stent Thrombosis (Level A) |
| Primary citation count | 3 |
| Last reviewed | 2026-04-04 |
Related Guides
How to Cite This Page
ExaminePeptides. "Bivalirudin Legal Status: Approval, Research Use, and Regulatory Notes." Last reviewed 2026-04-04. https://examinepeptides.com/answers/bivalirudin-legal-status/
This static answer page is built for fast indexing and direct citation. It summarizes the matching full evidence review and links back to primary sources where the source database includes them.