Overview
Icosapent ethyl or ethyl eicosapentaenoic acid is a synthetic derivative of the omega-3 fatty acid eicosapentaenoic acid (EPA). It is used as an adjunct therapy for severe hypertriglyceridemia (TG levels > 500 mg/dL) and to reduce the risk of cardiovascular events in certain patients with elevated triglycerides. FDA approved on July 26, 2012.
Indication
作为最大耐受他汀类药物治疗的辅助手段，以降低甘油三酯（TG）水平升高（≥150mg/dL）、已确定的心血管疾病或糖尿病以及2个或更多心血管疾病风险因素的成年患者需要住院治疗的心肌梗死、中风、冠状动脉血运重建和不稳定心绞痛的风险。
Associated Conditions
- Hospitalizations
- Severe Hypertriglyceridemias
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/26 | Phase 2 | Not yet recruiting | |||
2024/02/28 | Phase 4 | Withdrawn | |||
2020/08/10 | Phase 4 | Terminated | |||
2020/06/02 | Phase 2 | Completed | |||
2020/01/27 | Phase 3 | Completed | Mochida Pharmaceutical Company, Ltd. | ||
2020/01/02 | Phase 1 | Completed | |||
2019/11/26 | Phase 2 | Completed | |||
2018/02/09 | Phase 3 | Active, not recruiting | Mark A Hull, PhD FRCP | ||
2016/10/20 | Phase 2 | Terminated | |||
2016/10/06 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Pharmaceuticals USA Inc. | 70710-1592 | ORAL | 1 g in 1 1 | 5/1/2023 | |
| Dr. Reddy's Laboratories, Inc. | 43598-746 | ORAL | 500 mg in 1 1 | 6/14/2022 | |
| Northstar Rx LLC | 72603-129 | ORAL | 1 g in 1 1 | 10/31/2022 | |
| Golden State Medical Supply, Inc. | 60429-005 | ORAL | 1 g in 1 1 | 5/28/2025 | |
| Bryant Ranch Prepack | 63629-9311 | ORAL | 1 g in 1 1 | 11/4/2020 | |
| Amarin Pharma Inc. | 52937-003 | ORAL | 500 mg in 1 1 | 2/27/2017 | |
| Apotex Corp | 60505-4033 | ORAL | 1 g in 1 1 | 12/14/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0621 | ORAL | 0.5 g in 1 1 | 3/9/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-299 | ORAL | 1 g in 1 1 | 7/9/2023 | |
| Bryant Ranch Prepack | 63629-9312 | ORAL | 1000 mg in 1 1 | 7/7/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/26/2021 |
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 |
|---|---|---|---|---|---|
| Icosapent Ethyl Soft Capsules | 国药准字HJ20230058 | 化学药品 | 胶囊剂 | 5/29/2023 | |
| Icosapent Ethyl Soft Capsules | 国药准字H20233110 | 化学药品 | 胶囊剂 | 1/31/2023 | |
| Icosapent Ethyl Soft Capsules | 国药准字H20254286 | 化学药品 | 胶囊剂 | 5/27/2025 | |
| Icosapent Ethyl Soft Capsules | 国药准字H20254287 | 化学药品 | 胶囊剂 | 5/27/2025 |
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 |
|---|---|---|---|---|---|
| VAZKEPA icosapent ethyl 998 mg soft capsule bottle | 380980 | Medicine | A | 11/8/2022 | |
| VAZKEPA icosapent ethyl 998 mg soft capsule blister | 380979 | Medicine | A | 11/8/2022 |
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