Overview
Clopidogrel is a prodrug of a platelet inhibitor used to reduce the risk of myocardial infarction and stroke. Clopidogrel is indicated to reduce the risk of myocardial infarction for patients with non-ST elevated acute coronary syndrome (ACS), patients with ST-elevated myocardial infarction, and in recent MI, stroke, or established peripheral arterial disease, It has been shown to be superior to aspirin in reducing cardiovascular outcomes in patients with cardiovascular disease and provides additional benefit to patients with acute coronary syndromes already taking aspirin. Clopidogrel was granted FDA approval on 17 November 1997.
Background
Clopidogrel is a prodrug of a platelet inhibitor used to reduce the risk of myocardial infarction and stroke. Clopidogrel is indicated to reduce the risk of myocardial infarction for patients with non-ST elevated acute coronary syndrome (ACS), patients with ST-elevated myocardial infarction, and in recent MI, stroke, or established peripheral arterial disease, It has been shown to be superior to aspirin in reducing cardiovascular outcomes in patients with cardiovascular disease and provides additional benefit to patients with acute coronary syndromes already taking aspirin. Clopidogrel was granted FDA approval on 17 November 1997.
Indication
1.用于新近心肌梗死、新近脑卒中或确诊的周围动脉病变患者，可减少新的缺血性脑卒中、心肌梗死和死亡等心脑血管事件的符合终点； 2.用于急性冠状动脉综合征（不稳定心绞痛和非ST段抬高心肌梗死）患者； 3.用于冠状动脉支架置入术后预防支架内血栓形成（与阿司匹林联用）。
Associated Conditions
- Acute Coronary Syndrome (ACS)
- Acute Myocardial Infarction (AMI)
- Cardiovascular Events
- Atherothrombotic events
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/27 | Not Applicable | Not yet recruiting | |||
2025/06/17 | Phase 4 | Not yet recruiting | |||
2025/06/10 | Phase 3 | Not yet recruiting | Aarhus University Hospital | ||
2025/03/12 | Phase 2 | Active, not recruiting | |||
2025/02/11 | Phase 4 | Recruiting | |||
2025/02/04 | N/A | Active, not recruiting | Jose Carlos Nicolau | ||
2025/01/08 | Phase 4 | Not yet recruiting | |||
2025/01/03 | Phase 4 | Not yet recruiting | |||
2024/12/04 | N/A | Recruiting | |||
2024/12/03 | Not Applicable | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Viona Pharmaceuticals Inc | 72578-012 | ORAL | 75 mg in 1 1 | 11/20/2022 | |
| Dr.Reddy's Laboratories Limited | 55111-196 | ORAL | 75 mg in 1 1 | 9/30/2022 | |
| Major Pharmaceuticals | 0904-6467 | ORAL | 300 mg in 1 1 | 8/28/2023 | |
| A-S Medication Solutions | 50090-6567 | ORAL | 75 mg in 1 1 | 4/26/2023 | |
| RADHA PHARMACEUTICALS, INC. | 77771-124 | ORAL | 75 mg in 1 1 | 11/8/2023 | |
| State of Florida DOH Central Pharmacy | 53808-0616 | ORAL | 75 mg in 1 1 | 9/9/2013 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-269 | ORAL | 75 mg in 1 1 | 1/18/2017 | |
| American Health Packaging | 68084-536 | ORAL | 75 mg in 1 1 | 8/10/2023 | |
| Amneal Pharmaceuticals LLC | 65162-414 | ORAL | 75 mg in 1 1 | 11/19/2022 | |
| Westminster Pharmaceuticals, LLC | 69367-200 | ORAL | 75 mg in 1 1 | 7/31/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/14/1998 | ||
Authorised | 7/15/2008 | ||
Authorised | 3/14/2010 | ||
Authorised | 3/14/2010 | ||
Authorised | 7/15/2008 | ||
Authorised | 7/14/1998 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CLOPISWIFT FILM-COATED TABLET 75MG | SIN17130P | TABLET, FILM COATED | 75 mg | 10/30/2024 | |
| PLACTA TABLET 75 mg | SIN13844P | TABLET, FILM COATED | 75.00mg | 8/6/2010 | |
| ACORDOGREL CLOPIDOGREL TABLETS USP 75 MG | SIN16643P | TABLET, FILM COATED | 75 MG | 11/21/2022 | |
| Apo-Clopidogrel 75mg Tablet | SIN13571P | TABLET, FILM COATED | 75.0 mg | 11/13/2008 | |
| PLAVIX TABLET 75 mg | SIN09828P | TABLET, FILM COATED | 75 mg | 6/16/1998 | |
| CLOPIVID TABLET 75MG | SIN15153P | TABLET | 75mg | 1/9/2017 | |
| DEPLATT TABLET 75MG | SIN13820P | TABLET | 75 mg | 6/24/2010 | |
| Clopidogrel Sandoz Film Coated Tablet 75mg | SIN13746P | TABLET, FILM COATED | 75mg | 12/14/2009 | |
| CERUVIN TABLETS 75MG | SIN14037P | TABLET, FILM COATED | 75 mg | 10/21/2011 | |
| PLATEL FILM COATED TABLETS 75MG | SIN15871P | TABLET, FILM COATED | 75.00mg | 12/26/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Clopidogrel Bisulfate Tablets | 国药准字HJ20150256 | 化学药品 | 片剂 | 12/13/2024 | |
| Clopidogrel Bisulfate Tablets | 国药准字H20213330 | 化学药品 | 片剂 | 5/8/2021 | |
| Clopidogrel Bisulfate Tablets | 国药准字H20203637 | 化学药品 | 片剂 | 12/2/2020 | |
| Clopidogrel Bisulfate Tablets | 国药准字H20193160 | 化学药品 | 片剂 | 5/29/2019 | |
| Clopidogrel Bisulfate Tablets | 国药准字HJ20200049 | 化学药品 | 片剂 | 11/24/2020 | |
| Clopidogrel Bisulfate Tablets | 国药准字H20253784 | 化学药品 | 片剂 | 4/1/2025 | |
| Clopidogrel Bisulfate Tablets | 国药准字H20234612 | 化学药品 | 片剂 | 12/5/2023 | |
| Clopidogrel Bisulfate Tablets | 中国台湾培力药品工业股份有限公司 | 国药准字HC20220002 | 化学药品 | 片剂 | 7/7/2022 |
| Clopidogrel Bisulfate Tablets | 国药准字H20234617 | 化学药品 | 片剂 | 12/5/2023 | |
| Clopidogrel Bisulfate Tablets | H20150257 | 化学药品 | 片剂 | 5/20/2020 |
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. | |||||