LOVENOX (PRESERVATIVE FREE) (enoxaparin sodium)
Lovenox (enoxaparin sodium) is a low molecular weight heparin (LMWH) indicated for the prophylaxis of deep vein thrombosis (DVT) in patients undergoing abdominal, hip replacement, or knee replacement surgery, and in medical patients with severely restricted mobility during acute illness. It is also indicated for the inpatient treatment of acute DVT (with or without pulmonary embolism) and outpatient treatment of acute DVT (without pulmonary embolism) when administered in conjunction with warfarin sodium. Additionally, Lovenox is used to prevent ischemic complications of unstable angina and non-Q-wave myocardial infarction (when administered with aspirin) and for the treatment of acute ST-segment elevation myocardial infarction (STEMI), including patients managed medically or with subsequent percutaneous coronary intervention (PCI).
How LOVENOX (PRESERVATIVE FREE) Works
Enoxaparin is a low molecular weight heparin with potent antithrombotic properties. It acts by binding to and accelerating the activity of antithrombin III, which in turn inactivates clotting factors, primarily Factor Xa and, to a lesser extent, Factor IIa (thrombin). Enoxaparin is characterized by a higher ratio of anti-Factor Xa to anti-Factor IIa activity (approximately 3:1 to 5:1) compared to unfractionated heparin, providing a predictable antithrombotic response.
Details
- Status
- Prescription
- First Approved
- 1993-03-29
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
LOVENOX (PRESERVATIVE FREE) Approval History
What LOVENOX (PRESERVATIVE FREE) Treats
4 indicationsLOVENOX (PRESERVATIVE FREE) is approved for 4 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Deep Vein Thrombosis
- Pulmonary Embolism
- Unstable Angina
- Myocardial Infarction
LOVENOX (PRESERVATIVE FREE) Boxed Warning
SPINAL/EPIDURAL HEMATOMAS Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: Use of indwelling epidural catheter...
WARNING: SPINAL/EPIDURAL HEMATOMAS Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: Use of indwelling epidural catheters Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants A history of traumatic or repeated epidural or spinal punctures A history of spinal deformity or spinal surgery Optimal timing between the administration of enoxaparin sodium injection and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.1) and Drug Interactions (7) ] . WARNING: SPINAL/EPIDURAL HEMATOMAS See full prescribing information for complete boxed warning. Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: Use of indwelling epidural catheters Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, and other anticoagulants A history of traumatic or repeated
LOVENOX (PRESERVATIVE FREE) Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LOVENOX (PRESERVATIVE FREE)'s indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LOVENOX (PRESERVATIVE FREE) treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05735639 THRIVE | 22CX7510 ISRCTN18501431 | Ph 4 | recruiting | THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) |
| NCT04861103 | 20195544 | Ph 4 | recruiting | Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH) |
| NCT04406389 IMPACT results posted | 20-04021936 | Ph 4 | terminated | Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial) |
| NCT03083704 | 16-512 | Ph 1 | completed | A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa |
| NCT02081950 results posted | ENOXA/13/1 | Ph 1 | completed | A Single-Dose Trial to Examine the Within Subject Variability of Clexane® in Healthy Adults Under Fasting Conditions |
| NCT02232802 results posted | ENOXA/14/2 | Ph 1 | completed | Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c. |
| NCT04552067 Enoxaparine | Enoxaparine | Ph 1 | completed | Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients |
| NCT02152423 ENOXAMED | ENOXAMED | Ph 1 | completed | Enoxamed Study in the Treatment of Acute Coronary Syndromes |
| NCT01181102 results posted | DU176b-B-J302 | Ph 3 | completed | A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty |
| NCT01181167 results posted | DU176b-B-J304 | Ph 3 | completed | A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty |
| NCT01880216 | Bemiparin | Ph 3 | completed | Efficacy of Bemiparin Versus Enoxaparin in the Treatment of DVT |
| NCT00679588 SAVE-ABDO | EFC6520 2007-007942-36 | Ph 3 | completed | Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery |
| NCT00916669 | 08-097 | Ph 2 | withdrawn | A Randomized Study to Evaluate the Effect of Two Different Doses of Enoxaparin Sodium in Combination With Standard Chemotherapy in Patients With Stage Small Cell Lung Cancer (SCLC) |
| NCT00721760 SAVE-HIP2 | EFC10343 2007-007945-11 | Ph 3 | completed | Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery |
| NCT00714597 SAVE-VEMED | EFC10572 2008-000228-13 | Ph 3 | terminated | Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility |
| NCT00697099 SAVE-HIP1 | EFC10342 2007-007944-80 | Ph 3 | completed | Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LOVENOX (PRESERVATIVE FREE) FDA Label Details
Indications & Usage
FDA Label (PDF)LOVENOX (PRESERVATIVE FREE) is indicated for the treatment of Deep Vein Thrombosis; Pulmonary Embolism; Unstable Angina; Myocardial Infarction.
WARNING: SPINAL/EPIDURAL HEMATOMAS Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.