At a glance
- Bivalirudin is an FDA-approved drug, marketed as Angiomax, Bivalirudin (first approval: December 15, 2000).
- PubMed lists 2,097 publications mentioning it, including 279 randomized controlled trials and 60 animal-only studies.
- ClinicalTrials.gov lists 92 registered studies testing it (9 active).
- FDA's adverse event system (FAERS) holds 2,885 reports mentioning it; 2,688 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA020873 | ANGIOMAX | Approved, marketed | December 15, 2000 | SANDOZ |
| ANDA090811 | BIVALIRUDIN | Approved, discontinued | July 14, 2015 | HOSPIRA |
| ANDA090816 | BIVALIRUDIN | Approved, discontinued | July 14, 2015 | HOSPIRA |
| ANDA090189 | BIVALIRUDIN | Approved, marketed | October 28, 2016 | FRESENIUS KABI USA |
| ANDA201577 | BIVALIRUDIN | Approved, marketed | May 26, 2017 | DR REDDYS |
| ANDA204876 | BIVALIRUDIN | Approved, discontinued | July 6, 2017 | APOTEX |
| ANDA206551 | BIVALIRUDIN | Approved, marketed | November 22, 2017 | ACCORD HLTHCARE |
| NDA208374 | BIVALIRUDIN IN 0.9% SODIUM CHLORIDE | Approved, discontinued | December 21, 2017 | BAXTER HLTHCARE CORP |
| ANDA202471 | BIVALIRUDIN | Approved, marketed | June 1, 2018 | MYLAN INSTITUTIONAL |
| ANDA091602 | BIVALIRUDIN | Approved, marketed | July 16, 2018 | MEITHEAL |
| ANDA205962 | BIVALIRUDIN | Approved, discontinued | July 27, 2018 | EUGIA PHARMA |
| NDA211215 | ANGIOMAX RTU | Approved, marketed | July 25, 2019 | MAIA PHARMS INC |
| ANDA210031 | BIVALIRUDIN | Approved, marketed | October 23, 2019 | SHUANGCHENG |
| ANDA213078 | BIVALIRUDIN | Approved, marketed | May 28, 2021 | HAINAN POLY |
| ANDA091206 | BIVALIRUDIN | Tentative approval | — | PLIVA HRVATSKA DOO |
| ANDA091468 | BIVALIRUDIN | Tentative approval | — | MYLAN LABS LTD |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Comprehensive analysis of peptide pharmaceutical: Development of three orthogonal chromatographic methods and characterization of bivalirudin degradation products by high-resolution mass spectrometry.
- Bivalirudin Versus Heparin and Protamine in Adult Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-Analysis.
- Known Unknowns: Unpacking Controversies and Uncertainties in the 2025 Guidelines for Management of Acute Coronary Syndromes.
- Engineering Immunomodulatory Stents Using a Biomimetic Nanozyme System for Vascular Healing.
- Comparison of bivalirudin versus heparin in percutaneous coronary intervention for patients with acute coronary syndrome: A meta-analysis.
- Clinical outcomes of bivalirudin and heparin in pediatric extracorporeal membrane oxygenation: A systematic review and meta-analysis.
- Real-world outcomes of unfractionated heparin plus antithrombin concentrate versus bivalirudin in adult patients undergoing extracorporeal membrane oxygenation.
- Management of Heparin-Induced Thrombocytopenia With Plasmapheresis and IVIG Prior to Heart Transplantation: A Case Report.
- Bivalirudin in Primary PCI: Time to Implement the Overwhelming Evidence?
- Bivalirudin Versus Heparin in Low and Non-Low Bleeding Risk Patients Undergoing Primary PCI for STEMI: The BRIGHT-4 Trial.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 92
- Active
- 9
- With posted results
- 14
Conditions studied
Show 40 more studies
All 92 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 2,885
- Serious
- 2,688
- With death outcome
- 656
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- Bivalirudin
- BIVALIRUDIN
- bivalirudin
- Bivalirudin
- Bivalirudin
- Bivalirudin
- Bivalirudin
- Bivalirudin
- Bivalirudin
- BIVALIRUDIN
- Bivalirudin
- bivalirudin
- BIVALIRUDIN
- bivalirudin
- Bivalirudin
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.