enoxaparin
Trade name: lovenox
Approved
Mar 29, 1993
Enoxaparin is a low molecular weight heparin used as anticoagulant medication to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) including during pregnancy and following certain types of surgery. Enoxaparin is a depolymerized derivative of Unfractionated heparin produced by controlled depolymerization using alkaline hydrolysis of the heparin benzylic ester. Like Unfractionated heparin, its major anticoagulant effect is mediated by interaction with antithrombin III, which in turn inactivates serine proteases like factors IIa (thrombin), IXa and Xa. Therefore, enoxaparin indirectly inhibits the conversion of prothrombin to thrombin and reduces the thrombin-mediated conversion of fibrinogen to fibrin, thus preventing clot formation. Among parenteral anticoagulants, enoxaparin stands out for certain major advantages: rapid onset of action, higher bioavailability, once- or twice-daily dosing that can be administered by patients at home without any need for monitoring, and no reported association with catheter thrombosis. Enoxaparin has been shown to be a safe and effective drug in a wide variety of thromboembolic conditions, and two decades of available data have undoubtedly inspired significant confidence. Although these properties make it a preferred option in a wide range of clinical disorders, lack of reliable antidote and accumulation in renal dysfunction are major concerns associated with its use, which are shared, apart from Unfractionated heparin, by most other available anticoagulants. — NCATS
Clinical trial activity
420 trials · 446 clinical orgs · 12 marketing orgs
Earliest trial started Sep 1, 1998 (NCT00182403)
Timeline
1990s
- Mar 29, 1993
Sanofi-Aventis — Earliest FDA Approval
- Mar 29, 1993
Sanofi-Aventis — NDA Organization
- Mar 29, 1993
Sanofi-Aventis — NDA Secondary Org
- Jan 1, 1998
Earliest Phase 3 Sponsor(trial)
2010s
- Jul 23, 2010
Sandoz — Marketing Organization
- Jul 23, 2010
Novartis — Marketing Organization
- Sep 19, 2011
Amphastar Pharmaceuticals — Marketing Organization
- Jun 23, 2014
Teva — Marketing Organization
- Jun 23, 2014
Zydus Discovery DMCC — Marketing Organization
- Sep 28, 2018
Apotex — Marketing Organization
- Sep 28, 2018
Gland Pharma Ltd — Marketing Organization
- Sep 28, 2018
Fosun — Marketing Organization
- Nov 29, 2019
Nanjing King-Friend — Marketing Organization
2020s
- Mar 15, 2023
Shenzhen Techdow — Marketing Organization
- Jun 6, 2023
BE Pharmaceuticals — Marketing Organization
Indications
Approved for
Studied for
- Abdominal Neoplasms · Phase 3
- Abortion, Habitual · Phase 4
- Acute Coronary Syndrome · Phase 4
- Acute-On-Chronic Liver Failure · Phase 2
- Anesthesia · Phase 4
- Angina, Unstable · Phase 4
- Anticoagulants · Phase 4
- Antiphospholipid Syndrome · Phase 4
- Antithrombins · Phase 1/Phase 2
- Arrhythmias, Cardiac · Phase 3
- Arthroplasty · Phase 4
- Arthroplasty, Replacement, Hip · Phase 4
- Arthroplasty, Replacement, Knee · Phase 3
- Aspirin · Phase 3
- Atrial Fibrillation · Phase 4
- Bleeding Time · Phase 3
- Blood Coagulation · Phase 3
- Blood Loss, Surgical · Phase 4
- Blood Transfusion · Phase 4
- Brain Injuries · Phase 4
- Brain Injuries, Traumatic · Phase 4
- Carcinoma, Hepatocellular · Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carcinoma, Small Cell · Phase 2
- Cardiovascular Diseases · Phase 3
- Carotid Artery Diseases · Phase 3
- Catheter-Related Infections · Phase 3
- Catheters · Phase 2
- Central Venous Catheters · Phase 2
- Cerebral Hemorrhage · Phase 4
- Cervix Uteri · Phase 3
- Cesarean Section · Phase 1
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 2
- Colorectal Neoplasms · Phase 3
- Contusions · Phase 4
- Coronary Artery Disease · Phase 4
- Coronary Disease · Phase 4
- Coronavirus · Phase 2
- Coronavirus Infections · Phase 4
- COVID-19 · Phase 4
- Critical Illness · Phase 4
- Diabetes Mellitus, Type 1 · Phase 2
- Diabetic Angiopathies · Phase 2/Phase 3
- Diabetic Foot · Phase 3
- Drug Evaluation · Phase 3
- Drug Interactions · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 3
- Embolic Stroke · Phase 2
- Embolism · Phase 3
- Embolism and Thrombosis · Phase 2
- Enoxaparin · Phase 4
- Esophageal Neoplasms · Phase 3
- Extracorporeal Membrane Oxygenation · Phase 3
- Factor X · Phase 4
- Femoral Neck Fractures · Phase 4
- Femur Head Necrosis · Phase 4
- Fertilization in Vitro · Phase 3
- Fetal Growth Retardation · Phase 3
- Fibrosis · Phase 4
- Fractures, Bone · Phase 2
- Gastrointestinal Neoplasms · Phase 4
- General Surgery · Phase 4
- Genital Neoplasms, Female · Phase 3
- Growth and Development · Phase 3
- Head and Neck Neoplasms · Phase 4
- Healthy Volunteers · Phase 2
- Heart Failure · Phase 4
- Heart Valve Diseases · Phase 4
- Hematoma · Phase 4
- Hemodialysis, Home · Phase 4
- Hemorrhage · Phase 4
- Hemorrhagic Stroke · Phase 3
- Heparin, Low-Molecular-Weight · Phase 3
- Hip Fractures · Phase 3
- Hip Injuries · Phase 3
- Hypertension · Phase 4
- Hypertension, Portal · Phase 4
- Immobilization · Phase 3
- Infant, Premature, Diseases · Phase 3
- Infections · Phase 4
- Infertility · Phase 4
- Infertility, Female · Phase 4
- Inflammation · Phase 4
- Influenza A virus · Phase 3
- Influenza, Human · Phase 3
- Intestinal Neoplasms · Phase 4
- Ischemic Stroke · Phase 4
- Kidney Diseases · Phase 3
- Kidney Failure, Chronic · Phase 4
- Kidney Transplantation · Phase 4
- Knee · Phase 2
- Knee Injuries · Phase 3
- Laparoscopy · Phase 4
- Leg Injuries · Phase 3
- Live Birth · Phase 3
- Liver Cirrhosis · Phase 4
- Liver Diseases · Phase 3
- Liver Neoplasms · Phase 4
- Liver Transplantation · Phase 3
- Lung Diseases · Phase 2
- Lung Neoplasms · Phase 1/Phase 2
- Lymphoma · Phase 1/Phase 2
- Mitral Valve · Phase 4
- Mouth Neoplasms · Phase 2/Phase 3
- Myocardial Ischemia · Phase 4
- Neoplasm Metastasis · Phase 4
- Neoplasms · Phase 4
- Nephrotic Syndrome · Phase 2/Phase 3
- Obesity · Phase 4
- Obesity, Morbid · Phase 1/Phase 2
- Osteoarthritis, Hip · Phase 4
- Osteoarthritis, Knee · Phase 4
- Osteosarcoma · Phase 4
- Ovarian Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 4
- Pediatrics · Phase 3
- Percutaneous Coronary Intervention · Phase 4
- Peripheral Arterial Disease · Phase 4
- Peritoneal Diseases · Phase 2
- Pharmacokinetics · Phase 4
- Pharmacological and Toxicological Phenomena · Phase 4
- Placental Insufficiency · Phase 4
- Plastic Surgery Procedures · Phase 2
- Pneumonia · Phase 4
- Pneumonia, Bacterial · Phase 3
- Pneumonia, Viral · Phase 3
- Postpartum Period · Phase 4
- Pre-Eclampsia · Phase 3
- Pregnancy · Phase 3
- Pregnancy Complications · Phase 2
- Pregnancy, High-Risk · Phase 4
- Protein S Deficiency · Phase 2
- Pseudotumor Cerebri · Early Phase 1
- Pulmonary Embolism · Phase 4
- Purpura · Phase 1/Phase 2
- Radial Artery · Phase 2
- Radiation Oncology · Phase 2
- Renal Dialysis · Phase 4
- Renal Insufficiency · Phase 4
- Respiratory Insufficiency · Phase 4
- Retinal Diseases · Phase 3
- Rivaroxaban · Phase 3
- Sarcoma · Phase 4
- SARS-CoV-2 · Phase 4
- Sepsis · Phase 4
- Severe Acute Respiratory Syndrome · Phase 3
- Severe Fever with Thrombocytopenia Syndrome · Phase 4
- Shock · Phase 4
- Small Cell Lung Carcinoma · Phase 3
- Spinal Cord Injuries · Phase 2
- Splenectomy · Phase 4
- Staphylococcal Infections · Phase 2
- Stomach Neoplasms · Phase 3
- Stroke · Phase 4
- Thoracic Surgery · Phase 4
- Thrombocytopenia · Phase 4
- Thromboembolism · Phase 4
- Thrombophilia · Phase 3
- Thrombophlebitis · Phase 3
- Thrombosis · Phase 4
- Traumatology · Phase 4
- Upper Extremity Deep Vein Thrombosis · Phase 4
- Venous Cutdown · Phase 4
- Venous Thromboembolism · Phase 4
- Ventricular Dysfunction, Right · Phase 3
- Vertebral Artery Dissection · Phase 3
- Virus Diseases · Phase 2
- Vitreoretinopathy, Proliferative · Phase 3
- Vulvodynia · Phase 2
- Warfarin · Phase 4
- Wounds and Injuries · Phase 4
Mechanism of action
- Antithrombin-IIIACTIVATOR
SERPINC1 activator
Inhibits coagulation by activating antithrombin III; ATIII then binds to F10; It's a low-molecular-weight heparin
Approval history
- approvedPriority reviewMar 29, 1993
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- NCATSE47C0NF7LV ↗
- WikipediaLow-molecular-weight heparin ↗
- ChEMBLCHEMBL1201685 ↗
- ChEMBLCHEMBL1201476 ↗
- ChEMBLCHEMBL2109204 ↗
- WikipediaLow molecular weight heparin ↗
- WikipediaEnoxaparin sodium ↗
- ChEMBLCHEMBL2107886 ↗
Also known as
- cb-01-05-mmx
- clexane
- clexane
- clexane
- clivarin
- clivarine
- clivarine
- cy-216
- enoxaparin
- enoxaparin
- enoxaparin
- enoxaparin
- enoxaparin
- enoxaparin
- enoxaparin
- enoxaparine
- enoxaparine
- enoxaparine
- enoxaparin sodium
- enoxaparin sodium
- enoxaparin sodium
- enoxaparin sodium
- enoxaparin sodium
- enoxaparin sodium
- enoxaparin sodium
- eparina
- exoxaparin
- lmwh
- lmwh
- lmw heparin
- lmw heparin
- lovenox
- lovenox
- lovenox
- lovenox
- lovenox
- low molecular weight heparin
- low molecular weight heparin
- low-molecular weight heparin
- low-molecular weight heparin
- low-molecular-weight heparin
- low-molecular-weight heparin
- lu 47311
- lu-47311
- pk-10169
- pk-10169
- reviparin
- reviparin
- reviparin
- reviparin
- reviparine
- reviparin sodium
- reviparin sodium
- reviparin sodium
- reviparin sodium
- reviparin-sodium
- rp-54563
- rp-54563
- sodium enoxaparin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07312851 | Phase 1 | Jan 12, 2026 | AstraZeneca, Parexel |
| NCT07228663 | Phase 3 | Dec 1, 2025 | Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, McMaster University |
| NCT07189897 | Phase 4 | Oct 31, 2025 | State University of New York, Syracuse |
| NCT07243080 | Phase 4 | Oct 10, 2025 | King Edward Medical University, Mayo Clinic |
| NCT07116239 | N/A | Sep 30, 2025 | Chinese Academy of Medical Sciences, Peking University |
| NCT07140523 | Phase 2 | Aug 15, 2025 | Sirius Medicine |
| NCT07015905 | Phase 3 | Jun 25, 2025 | Regeneron |
| NCT06845423 | Phase 4 | Apr 30, 2025 | University of Western Brittany |
| NCT06825416 | Phase 3 | Mar 14, 2025 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| NCT06818279 | Phase 2/Phase 3 (Phase 3) | Jan 31, 2025 | Institute of Liver and Biliary Sciences, India |
| NCT06963320 | Phase 2 | Jan 20, 2025 | Livzon Pharmaceutical Group Inc. |
| NCT07270263 | N/A | Nov 22, 2024 | Medical University of Gdansk |
| NCT06370273 | Phase 3 | Nov 12, 2024 | University of London |
| NCT06583330 | N/A | Oct 31, 2024 | Capital Medical University |
| NCT06689241 | N/A | Oct 1, 2024 | Alexandria University |
| NCT06494878 | Phase 3 | Sep 30, 2024 | Canadian Institutes of Health Research (CIHR), McGill University, University of Calgary |
| NCT06517563 | Phase 1 | Aug 14, 2024 | VarmX B.V. |
| NCT06531525 | Phase 2 | Aug 1, 2024 | Capital Medical University, Central South University, Chinese Academy of Medical Sciences, Peking University, People's Liberation Army of China, Sichuan University |
| NCT06442267 | Phase 4 | Jul 30, 2024 | Medical University of Vienna |
| NCT07124819 | Phase 3 | Jul 22, 2024 | Government of Russia |
Organizations
Research & Development (446)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 38 | 22 | 5 | 1999 |
| Bayer | For profit | 19 | 16 | 2 | 2002 |
| McMaster University | Academic/Hospital | 15 | 8 | 5 | 1998 |
| Boehringer Ingelheim | For profit | 10 | 9 | 3 | 2000 |
| Bristol-Myers Squibb | For profit | 10 | 8 | 2 | 2004 |
| University of Barcelona | Academic/Hospital | 10 | 3 | 4 | 2005 |
| University of Utah | Academic/Hospital | 10 | 10 | 4 | 2007 |
| Harvard University | Academic/Hospital | 9 | 7 | 4 | 2006 |
| Canadian Institutes of Health Research (CIHR) | Academic/Hospital | 7 | 0 | 3 | 2000 |
| Daiichi Sankyo | For profit | 7 | 7 | 2 | 2008 |
| Ain Shams University | Academic/Hospital | 6 | 5 | 2 | 2015 |
| Capital Medical University | Academic/Hospital | 6 | 5 | 3 | 2009 |
| Johnson and Johnson | For profit | 6 | 1 | 2 | 2004 |
| University of Paris | Academic/Hospital | 6 | 4 | 1 | 2007 |
| Eli Lilly | For profit | 5 | 3 | 3 | 2002 |
| Pfizer | For profit | 5 | 1 | 4 | 2000 |
| Rovi Pharmaceuticals Laboratories | For profit | 5 | 4 | 2 | 2001 |
| University of Helsinki | Academic/Hospital | 5 | 3 | 2 | 2002 |
| University of Toronto | Academic/Hospital | 5 | 3 | 4 | 2000 |
| Astellas | For profit | 4 | 4 | 2 | 2006 |
Marketing (15)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Amphastar Pharmaceuticals | For profit | MKTG | Sep 19, 2011 |
| Amphastar Pharmaceuticals | For profit | SYN | Mar 14, 2019 |
| Apotex | For profit | MKTG | Sep 28, 2018 |
| BE Pharmaceuticals | For profit | MKTG | Jun 6, 2023 |
| Fosun | For profit | MKTG | Sep 28, 2018 |
| Gland Pharma Ltd | For profit | MKTG | Sep 28, 2018 |
| Nanjing King-Friend | For profit | MKTG | Nov 29, 2019 |
| Novartis | For profit | MKTG | Jul 23, 2010 |
| Sandoz | For profit | MKTG | Jul 23, 2010 |
| Sandoz | For profit | SYN | Nov 28, 2011 |
| Sanofi-Aventis | For profit | NDA | Mar 29, 1993 |
| Sanofi-Aventis | For profit | NDA2 | Mar 29, 1993 |
| Shenzhen Techdow | For profit | MKTG | Mar 15, 2023 |
| Teva | For profit | MKTG | Jun 23, 2014 |
| Zydus Discovery DMCC | For profit | MKTG | Jun 23, 2014 |