Overview
Enoxaparin is a common low-molecular-weight heparin (LMWH) used in the prevention and management of various thromboembolic disorders. Initially approved by the FDA in 1993, it is administered by a subcutaneous or intravenous injection and marketed by several pharmaceutical companies. Enoxaparin markedly reduces the incidence of venous thromboembolism in hospitalized patients when compared to unfractionated heparin, without increasing the risk of serious bleeding.
Indication
Enoxaparin is indicated for the prevention of ischemic complications in unstable angina and in non Q-wave myocardial infarction; it is indicated in conjunction with percutaneous intervention and/or other treatment for the management of acute ST elevation myocardial infarction. Enoxaparin is also indicated in the prophylaxis of DVT in abdominal surgery, hip replacement, knee replacement, or medical patients with severely restricted mobility during acute illness. Additionally, enoxaparin is indicated for the inpatient treatment of DVT with or without pulmonary embolism and the treatment of outpatient DVT without pulmonary embolism.
Associated Conditions
- Acute Coronary Syndrome (ACS)
- Acute Myocardial Infarction With ST Segment Elevation
- Deep Vein Thrombosis
- Ischemic complications caused by non-q wave myocardial infarction
- Ischemic complications caused by unstable angina
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/11 | Phase 3 | Not yet recruiting | |||
2025/05/09 | Phase 2 | Recruiting | |||
2025/03/25 | Phase 3 | Recruiting | Beijing Suncadia Pharmaceuticals Co., Ltd | ||
2025/02/10 | Phase 2 | Not yet recruiting | |||
2025/01/28 | Phase 2 | Completed | |||
2024/11/14 | Not Applicable | Recruiting | |||
2024/10/10 | Phase 4 | Completed | |||
2024/08/01 | Phase 2 | Not yet recruiting | |||
2024/07/24 | Phase 1 | Recruiting | VarmX B.V. | ||
2024/06/12 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sandoz Inc | 0781-3256 | SUBCUTANEOUS | 100 mg in 1 mL | 1/23/2019 | |
| Fresenius Kabi USA, LLC | 63323-607 | SUBCUTANEOUS | 60 mg in 0.6 mL | 12/29/2021 | |
| Meitheal Pharmaceuticals Inc. | 71288-438 | SUBCUTANEOUS | 150 mg in 1 mL | 7/19/2022 | |
| Sanofi-Aventis U.S. LLC | 0075-0626 | SUBCUTANEOUS, INTRAVENOUS | 300 mg in 3 mL | 12/29/2021 | |
| Apotex Corp. | 60505-0796 | SUBCUTANEOUS | 120 mg in 0.8 mL | 7/21/2023 | |
| Cardinal Health 107, LLC | 55154-3544 | SUBCUTANEOUS | 100 mg in 1 mL | 1/31/2023 | |
| NorthStar Rx LLC | 16714-066 | SUBCUTANEOUS | 150 mg in 1 mL | 12/31/2020 | |
| NorthStar RxLLC | 72603-175 | SUBCUTANEOUS | 40 mg in 0.4 mL | 8/30/2023 | |
| Italfarmaco SpA | 11797-763 | INTRAVENOUS, SUBCUTANEOUS | 150 mg in 1 mL | 11/5/2022 | |
| Fresenius Kabi USA, LLC | 63323-586 | SUBCUTANEOUS | 100 mg in 1 mL | 1/3/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/15/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| INHIXA Solution for Injection 6000 Anti-Xa IU (60MG)/0.6ML | SIN16997P | INJECTION, SOLUTION | 6000 IU (60 MG)/0.6 ML | 5/7/2024 | |
| INHIXA Solution for Injection 2000 Anti-Xa IU (20MG)/0.2ML | SIN16999P | INJECTION, SOLUTION | 2000 IU (20 MG)/0.2 ML | 5/7/2024 | |
| CLEXANE INJECTION 8000 IU (80mg)/0.8 ml | SIN14094P | INJECTION | 8000 IU (80mg)/0.8ml | 2/6/2012 | |
| INHIXA Solution for Injection 4000 Anti-Xa IU (40MG)/0.4ML | SIN16998P | INJECTION, SOLUTION | 4000 IU (40 MG)/0.4 ML | 5/7/2024 | |
| CLEXANE INJECTION 4000 IU (40mg)/0.4 ml | SIN14095P | INJECTION | 4000 IU (40mg)/0.4 ml | 2/6/2012 | |
| CLEXANE INJECTION 2000 IU (20mg)/0.2 ml | SIN07668P | INJECTION | 2000 iu (20 mg)/0.2 ml | 9/13/1993 | |
| CLEXANE INJECTION 6000 IU (60mg)/0.6 ml | SIN14096P | INJECTION | 6000 iu (60mg)/0.6 ml | 2/6/2012 | |
| INHIXA SOLUTION FOR INJECTION 8000 ANTI-Xa IU (80MG)/0.8ML | SIN16331P | INJECTION, SOLUTION | 8000 anti-Xa IU (80mg)/0.8ml | 9/22/2021 | |
| ENOXAPARIN SANDOZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 8,000 IU (80 MG)/ 0.8 ML | SIN17084P | INJECTION, SOLUTION | 8,000 IU (80 MG) /0.8 ML | 9/11/2024 | |
| ENOXAPARIN SANDOZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6,000 IU (60 MG)/ 0.6 ML | SIN17086P | INJECTION, SOLUTION | 6,000 IU (60 MG) /0.6 ML | 9/11/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Enoxaparin Sodium Injection | 国药准字H20056848 | 化学药品 | 注射剂 | 12/5/2019 | |
| Enoxaparin Sodium Injection | 国药准字H20223252 | 化学药品 | 注射剂 | 4/27/2022 | |
| Enoxaparin Sodium Injection | 国药准字H20233927 | 化学药品 | 注射剂 | 7/11/2023 | |
| Enoxaparin Sodium Injection | 国药准字H20056850 | 化学药品 | 注射剂 | 12/5/2019 | |
| Enoxaparin Sodium Injection | 国药准字H20223859 | 化学药品 | 注射剂 | 11/15/2022 | |
| Enoxaparin Sodium Injection | 国药准字H20153025 | 化学药品 | 注射剂 | 12/2/2019 | |
| Enoxaparin Sodium Injection | 国药准字H20143003 | 化学药品 | 注射剂 | 9/22/2023 | |
| Enoxaparin Sodium Injection | 国药准字H20173386 | 化学药品 | 注射剂 | 9/29/2022 | |
| Enoxaparin Sodium Injection | 国药准字H20173385 | 化学药品 | 注射剂 | 9/29/2022 | |
| Enoxaparin Sodium Injection | 国药准字H20056849 | 化学药品 | 注射剂 | 12/5/2019 |
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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