Overview
Synthetic cyclic hexapeptide that binds to platelet receptor glycoprotein and inhibits platelet aggregation. Derived from venom of the Southeastern pygmy rattlesnake (Sistrurus miliarus barbouri), eptifibatide is a cyclic heptapeptide that belongs to the class of arginin-glycin-aspartat-mimetics.
Background
Synthetic cyclic hexapeptide that binds to platelet receptor glycoprotein and inhibits platelet aggregation. Derived from venom of the Southeastern pygmy rattlesnake (Sistrurus miliarus barbouri), eptifibatide is a cyclic heptapeptide that belongs to the class of arginin-glycin-aspartat-mimetics.
Indication
For treatment of myocardial infarction and acute coronary syndrome.
Associated Conditions
- Acute Coronary Syndrome (ACS)
- Percutaneous Coronary Intervention (PCI)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/02/18 | Phase 3 | UNKNOWN | Ministry of Science and Technology of the People´s Republic of China | ||
2018/11/08 | Phase 3 | Completed | |||
2016/10/06 | Phase 2 | Completed | |||
2013/11/06 | Phase 2 | Completed | Arthur Pancioli | ||
2013/08/09 | Phase 2 | Completed | |||
2013/05/27 | Phase 4 | Completed | |||
2012/02/14 | Phase 2 | Terminated | |||
2012/01/31 | Phase 2 | Completed | |||
2011/10/19 | Phase 4 | Terminated | University of Turin, Italy | ||
2010/02/26 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Athenex Pharmaceutical Division, LLC. | 70860-305 | INTRAVENOUS | 0.75 mg in 1 mL | 3/3/2024 | |
| Athenex Pharmaceutical Division, LLC. | 70860-303 | INTRAVENOUS | 2 mg in 1 mL | 3/3/2024 | |
| Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 52958-040 | INTRAVENOUS | 0.75 mg in 1 mL | 4/21/2022 | |
| Avenacy, Inc. | 83634-300 | INTRAVENOUS | 2 mg in 1 mL | 1/31/2024 | |
| Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 52958-402 | INTRAVENOUS | 2 mg in 1 mL | 4/21/2022 | |
| Hainan Poly Pharm. Co., Ltd. | 14335-070 | INTRAVENOUS | 2 mg in 1 mL | 4/27/2021 | |
| USV Private Limited | 62147-0600 | INTRAVENOUS | 2 mg in 1 mL | 3/18/2019 | |
| Amneal Pharmaceuticals LLC | 70121-1002 | INTRAVENOUS | 2 mg in 1 mL | 7/25/2021 | |
| Mylan Institutional LLC | 67457-630 | INTRAVENOUS | 2 mg in 1 mL | 12/17/2018 | |
| Sagent Pharmaceuticals | 25021-409 | INTRAVENOUS | 2 mg in 1 mL | 3/22/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/1/1999 | ||
Authorised | 1/11/2016 | ||
Authorised | 1/11/2016 | ||
Authorised | 7/1/1999 |
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 |
|---|---|---|---|---|---|
| Eptifibatide Injection | 国药准字H20249015 | 化学药品 | 注射剂 | 10/9/2024 | |
| Eptifibatide Injection | 国药准字H20140142 | 化学药品 | 注射剂 | 12/5/2019 | |
| Eptifibatide Injection | 国药准字H20213288 | 化学药品 | 注射剂 | 4/20/2021 | |
| Eptifibatide Injection | 国药准字H20213587 | 化学药品 | 注射剂 | 7/20/2021 | |
| Eptifibatide Injection | 国药准字H20223206 | 化学药品 | 注射剂 | 4/8/2022 | |
| Eptifibatide Injection | 国药准字H20213582 | 化学药品 | 注射剂 | 7/20/2021 | |
| Eptifibatide Injection | 国药准字H20203646 | 化学药品 | 注射剂 | 12/8/2020 | |
| Eptifibatide Injection | 国药准字H20120093 | 化学药品 | 注射剂 | 5/16/2022 | |
| Eptifibatide Injection | 国药准字H20184117 | 化学药品 | 注射剂 | 12/5/2019 | |
| Eptifibatide Injection | 国药准字H20243134 | 化学药品 | 注射剂 | 2/6/2024 |
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. | |||||