Overview
Bivalirudin is a synthetic 20 residue peptide (thrombin inhibitor) which reversibly inhibits thrombin. Once bound to the active site, thrombin cannot activate fibrinogen into fibrin, the crucial step in the formation of thrombus. It is administered intravenously. Because it can cause blood stagnation, it is important to monitor changes in hematocrit, activated partial thromboplastin time, international normalized ratio and blood pressure.
Indication
For treatment of heparin-induced thrombocytopenia and for the prevention of thrombosis. Bivalirudin is indicated for use in patients undergoing percutaneous coronary intervention (PCI), in patients at moderate to high risk acute coronary syndromes due to unstable angina or non-ST segment elevation in whom a PCI is planned.
Associated Conditions
- Thrombosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/06 | Not Applicable | Not yet recruiting | |||
2024/02/23 | Not Applicable | Not yet recruiting | Xiaotong Hou | ||
2023/08/09 | Phase 4 | Recruiting | |||
2023/07/25 | Phase 2 | Recruiting | |||
2022/04/19 | Not Applicable | Completed | University Magna Graecia | ||
2020/08/31 | Phase 3 | UNKNOWN | |||
2020/07/17 | Not Applicable | UNKNOWN | |||
2020/06/24 | Phase 4 | UNKNOWN | |||
2019/12/12 | Phase 4 | UNKNOWN | Shanghai Zhongshan Hospital | ||
2019/12/04 | Phase 4 | UNKNOWN | Second Xiangya Hospital of Central South University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Civica, Inc. | 72572-035 | INTRAVENOUS | 250 mg in 1 1 | 7/20/2020 | |
| Sandoz Inc | 0781-9158 | INTRAVENOUS | 250 mg in 1 1 | 9/30/2019 | |
| Eugia US LLC | 55150-210 | INTRAVENOUS | 250 mg in 1 1 | 8/23/2023 | |
| Slate Run Pharmaceuticals, LLC | 70436-025 | INTRAVENOUS | 250 mg in 1 1 | 6/9/2021 | |
| Avenacy, Inc. | 83634-400 | INTRAVENOUS | 250 mg in 1 1 | 12/18/2023 | |
| Pharma Packaging Solutions, LLC dba Tjoapack LLC | 75929-217 | INTRAVENOUS | 250 mg in 1 1 | 3/7/2024 | |
| Fresenius Kabi USA, LLC | 63323-562 | INTRAVENOUS | 250 mg in 1 1 | 10/28/2016 | |
| Sandoz Inc | 0781-3447 | INTRAVENOUS | 250 mg in 1 1 | 6/30/2019 | |
| Mylan Institutional LLC | 67457-256 | INTRAVENOUS | 250 mg in 5 mL | 3/7/2017 | |
| Hospira, Inc. | 0409-8300 | INTRAVENOUS | 250 mg in 1 1 | 8/1/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bivalirudin for Injection | 国药准字H20213183 | 化学药品 | 注射剂 | 3/16/2021 | |
| Bivalirudin for Injection | 国药准字H20233081 | 化学药品 | 注射剂 | 1/19/2023 | |
| Bivalirudin for Injection | 国药准字H20244244 | 化学药品 | 注射剂 | 6/28/2024 | |
| Bivalirudin for Injection | 国药准字H20233652 | 化学药品 | 注射剂 | 9/28/2023 | |
| Bivalirudin for Injection | 国药准字H20233584 | 化学药品 | 注射剂 | 5/19/2023 | |
| Bivalirudin for Injection | 国药准字H20203510 | 化学药品 | 注射剂 | 9/30/2020 | |
| Bivalirudin for Injection | 国药准字H20223462 | 化学药品 | 注射剂 | 6/30/2022 | |
| Bivalirudin for Injection | 国药准字H20110095 | 化学药品 | 注射剂 | 10/19/2020 | |
| Bivalirudin for Injection | 国药准字H20203009 | 化学药品 | 注射剂 | 1/14/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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