ENOXAPARIN SODIUM (PRESERVATIVE FREE) (enoxaparin sodium)
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, as well as medical patients with severely restricted mobility during acute illness. It is also indicated for the inpatient and outpatient treatment of acute DVT (with or without pulmonary embolism) and the management of acute coronary syndromes, including prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction (NQMI), and the treatment of acute ST-segment elevation myocardial infarction (STEMI).
How ENOXAPARIN SODIUM (PRESERVATIVE FREE) Works
Enoxaparin is a low molecular weight heparin with antithrombotic properties. It acts by increasing the inhibition rate of clotting factors Xa and IIa (thrombin) by activating antithrombin III. Characteristically, enoxaparin exhibits a higher ratio of anti-Factor Xa to anti-Factor IIa activity (approximately 3:1 to 5:1) compared to unfractionated heparin.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-07-23
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
Companies
ENOXAPARIN SODIUM (PRESERVATIVE FREE) Approval History
What ENOXAPARIN SODIUM (PRESERVATIVE FREE) Treats
4 indicationsENOXAPARIN SODIUM (PRESERVATIVE FREE) is approved for 4 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Deep Vein Thrombosis
- Pulmonary Embolism
- Unstable Angina
- Myocardial Infarction
ENOXAPARIN SODIUM (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
ENOXAPARIN SODIUM (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 ENOXAPARIN SODIUM (PRESERVATIVE FREE)'s indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ENOXAPARIN SODIUM (PRESERVATIVE FREE) treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ENOXAPARIN SODIUM (PRESERVATIVE FREE)
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
109 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06517563 | VMX-C001-02 2022-003675-41 | Ph 1 | completed | Effects of VMX-C001 on the Anticoagulant Effect of Different Forms of Heparin |
| NCT07015905 ROXI-APEX | R7508-DVT-24116 2025-520478-20-00 | Ph 3 | recruiting | REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults |
| NCT06628778 | IRB00507234-CRITICAL-Teens-TP | Ph 3 | not yet recruiting | Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP). |
| NCT05735639 THRIVE | 22CX7510 ISRCTN18501431 | Ph 4 | recruiting | THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) |
| NCT07312851 | D9609C00001 2025-522513-30-00 | Ph 1 | recruiting | A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants |
| NCT06454630 ROXI-VTE II results posted | R7508-DVT-2360 2023-508602-14-00 | Ph 2 | completed | A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants |
| NCT07140523 | SRSD107-201 | Ph 2 | recruiting | A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA |
| NCT05255003 | START Pilot | Ph 4 | recruiting | STrategies for Anticoagulation in Patients With thRombocytopenia and Cancer-associated Thrombosis |
| NCT05203705 | SHR2285-201 | Ph 2 | terminated | Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty |
| NCT07189897 | 2225826-3 | Ph 4 | recruiting | Apixaban or Enoxaparin After Head and Neck Cancer Surgery |
| NCT06180889 | KN060-A-201 | Ph 2 | active not recruiting | Factor XI inhibiTion for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty |
| NCT06118957 results posted | IRB_00167480 | Ph 2 | completed | Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery |
| NCT05618808 results posted | R9933-DVT-2230 2022-501470-18-00 | Ph 2 | completed | A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants |
| NCT04924322 CRETE | 2000030683 1R01HD106326-01 | Ph 2, Ph 3 | recruiting | Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies |
| NCT05895136 COMBAT | COMBAT | Ph 2 | recruiting | A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial). |
| NCT06818279 | ILBS-Cirrhosis-72 | Ph 2, Ph 3 | not yet recruiting | Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis |
| NCT06795698 FAA | 257/18 | Ph 2 | completed | The Effect of Prophylactic Anticoagulation on Major Bleeding Events in Hospitalized Chronic Kidney Disease and Lower Limb Fracture Patients. |
| NCT03532139 | 18-067 1R34HL135226-01 | Ph 2 | completed | Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O-STAT Study) |
| NCT04427098 INHIXACOV19 | 2020-001308-40 | Ph 2 | completed | Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients |
| NCT06635317 | 151.2022 151.2022 | Ph 4 | completed | Efficacy of Aspirin in Preventing Venous Thromboembolism |
| NCT06531525 | PKU-PS-01 | Ph 2 | not yet recruiting | Effect of Low Molecular Heparin on Pregnancy Outcome With Protein S Deficiency |
| NCT03339349 results posted | 102526 | Ph 2 | completed | Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma |
| NCT03083184 ETERNITY | CHU-0307 2016-A00180-51 | Ph 3 | recruiting | Evaluation of the Efficacy of an inTerdialytic "Ethanol 40% v/v - enoxapaRin 1000 U/mL" Lock solutioN to Prevent Tunnelled Catheter Infections in Chronic Hemodialysis Patients |
| NCT03296033 results posted | IRB00044503 | Ph 4 | terminated | Residual Anti-Xa Activity After Last Treatment Dose of Enoxaparin |
| 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 |
| NCT04373707 COVI-DOSE | 2020-001709-21 | Ph 4 | completed | Weight-Adjusted vs Fixed Low Doses of Low Molecular Weight Heparin For Venous Thromboembolism Prevention in COVID-19 |
| NCT01583218 APEX results posted | 11-019 | Ph 3 | completed | Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study) |
| NCT04646655 EMOS-COVID | HLS-02COVID19/2020 | Ph 3 | completed | Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19 |
| NCT05878899 PP-HEP | UGeneva 2021-02350 | Ph 3 | completed | Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial |
| NCT02474212 | 290115-1 | Ph 4 | completed | : Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery |
| NCT03664180 RIGHT | 2018024X BJUHFRIGHT201802 | Ph 4 | completed | Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI |
| NCT02923115 results posted | DS1040-B-U107 2015-005211-32 | Ph 1, Ph 2 | completed | Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism |
| NCT04512079 FREEDOM COVID | GCO 20-2115 | Ph 4 | completed | FREEDOM COVID-19 Anticoagulation Strategy |
| NCT04558892 ENOX-inNS | 5/8952 (443) | Ph 2, Ph 3 | terminated | Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome. |
| NCT03568838 PENNYWISE | STH19902 | Ph 4 | completed | Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention |
| NCT02379806 SYMPTOMS | 29BRC14.0012 SYMPTOMS 2014-000311-13 | Ph 3 | completed | The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study |
| NCT05417997 | APRON 2020-OK-01 | Ph 3 | completed | Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients |
| NCT04492254 ETHIC | TRI-08892 2020-003125-39 | Ph 3 | terminated | Early Prophylactic Low-molecular-weight Heparin (LMWH) in Symptomatic COVID-19 Positive Patients |
| NCT03363035 H-REPLACE | H-REPLACE-201711 | Ph 4 | completed | Safety and Efficacy of LMWH Versus Rivaroxaban in Chinese Patients Hospitalized With Acute Coronary Syndrome |
| NCT05172115 CANARY | 97056 | Ph 3 | terminated | Catheter-Directed Thrombolysis Versus Anticoagulation Monotherapy in Intermediate-High Risk PE |
| NCT04401293 results posted | 20-0340 | Ph 3 | completed | Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients |
| NCT04558125 results posted | ML42522 | Ph 4 | terminated | Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism |
| NCT04345848 COVID-HEP | 2020-00794 | Ph 3 | terminated | Preventing COVID-19 Complications With Low- and High-dose Anticoagulation |
| NCT01573169 PREVENTIHS results posted | PREVENTIHS | Ph 3 | terminated | PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients |
| NCT02706249 results posted | 15-547 | Ph 2 | completed | Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients |
| NCT04640181 XACT | 2020-001708-41 | Ph 2 | completed | Factor Xa Inhibitor Versus Standard of Care Heparin in Hospitalized Patients With COVID-19 (XACT) |
| NCT04366960 X-Covid 19 | 2020-001708-41 | Ph 3 | completed | Comparison of Two Doses of Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients |
| NCT01014403 DEEP results posted | 082009-026 | Ph 1 | completed | Delayed Versus Early Enoxaparin Prophylaxis After Traumatic Brain Injury (TBI) |
| NCT03812328 COURSE results posted | SELK2-00005 2018-003122-88 | Ph 2 | completed | Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement |
Showing 50 of 109 trials
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.
ENOXAPARIN SODIUM (PRESERVATIVE FREE) FDA Label Details
Indications & Usage
ENOXAPARIN SODIUM (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. ...
Track ENOXAPARIN SODIUM (PRESERVATIVE FREE) with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment