Overview
Argatroban is a direct, selective thrombin inhibitor. The American College of Cardiologists (ACC) recommend using bivalirudin or argatroban in patients who have had, or at risk for, heparin induced thrombocytopenia (HIT) and are undergoing percutaneous coronary intervention. Argatroban is a non-heparin anticoagulant shown to both normalize platelet count in patients with HIT and prevent the formation of thrombi. Parental anticoagulants must be stopped and a baseline activated partial thromboplastin time must be obtained prior to administering argatroban.
Background
Argatroban is a direct, selective thrombin inhibitor. The American College of Cardiologists (ACC) recommend using bivalirudin or argatroban in patients who have had, or at risk for, heparin induced thrombocytopenia (HIT) and are undergoing percutaneous coronary intervention. Argatroban is a non-heparin anticoagulant shown to both normalize platelet count in patients with HIT and prevent the formation of thrombi. Parental anticoagulants must be stopped and a baseline activated partial thromboplastin time must be obtained prior to administering argatroban.
Indication
Argatroban is indicated for prevention and treatment of thrombosis caused by heparin-induced thrombocytopenia (HIT). It is also indicated for use in patients with, or at risk for, HIT who are undergoing percutaneous coronary intervention.
Associated Conditions
- Thrombosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/09/15 | N/A | Completed | University Hospital Ostrava | ||
2023/02/23 | Phase 4 | Completed | Mitsubishi Tanabe Pharma GmbH | ||
2022/04/13 | Phase 1 | Completed | Veralox Therapeutics | ||
2022/02/07 | Phase 2 | Recruiting | |||
2021/06/14 | Not Applicable | Completed | Beijing Chao Yang Hospital | ||
2020/05/28 | Phase 4 | Terminated | |||
2020/02/19 | Phase 4 | Completed | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2019/01/18 | Phase 3 | Terminated | |||
2018/11/14 | Phase 4 | Completed | General Hospital of Shenyang Military Region | ||
2018/11/08 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 65219-429 | INTRAVENOUS | 50 mg in 50 mL | 3/1/2021 | |
| Mylan Institutional LLC | 67457-212 | INTRAVENOUS | 250 mg in 2.5 mL | 8/29/2017 | |
| Hospira, Inc. | 0409-1140 | INTRAVENOUS | 100 mg in 1 mL | 9/15/2019 | |
| Par Pharmaceutical, Inc. | 42023-182 | INTRAVENOUS | 250 mg in 2.5 mL | 2/9/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9288 | INTRAVENOUS | 250 mg in 2.5 mL | 10/20/2020 | |
| Sagent Pharmaceuticals | 25021-414 | INTRAVENOUS | 1 mg in 1 mL | 3/3/2021 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9674 | INTRAVENOUS | 250 mg in 2.5 mL | 11/18/2020 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9559 | INTRAVENOUS | 50 mg in 50 mL | 11/18/2020 | |
| Caplin Steriles Limited | 65145-126 | INTRAVENOUS | 50 mg in 50 mL | 2/1/2021 | |
| Accord Healthcare Inc. | 16729-430 | INTRAVENOUS | 1 mg in 1 mL | 11/7/2022 |
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 |
|---|---|---|---|---|---|
| Argatroban Injection | 国药准字H20249222 | 化学药品 | 注射剂 | 10/29/2024 | |
| Argatroban Injection | 国药准字HJ20150681 | 化学药品 | 注射剂 | 9/27/2024 | |
| Argatroban Injection | 国药准字H20244393 | 化学药品 | 注射剂 | 7/9/2024 | |
| Argatroban Injection | 国药准字H20253523 | 化学药品 | 注射剂 | 3/4/2025 | |
| Argatroban Injection | 国药准字H20237006 | 化学药品 | 注射剂 | 1/17/2023 | |
| Argatroban Injection | 国药准字H20193263 | 化学药品 | 注射剂 | 5/11/2024 | |
| Argatroban Injection | 国药准字H20234015 | 化学药品 | 注射剂 | 8/1/2023 | |
| Argatroban Injection | 国药准字H20233252 | 化学药品 | 注射剂 | 3/7/2023 | |
| Argatroban Injection | 国药准字H20223785 | 化学药品 | 注射剂 | 11/1/2022 | |
| Argatroban Injection | 国药准字H20233471 | 化学药品 | 注射剂 | 4/17/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||