Enoxaparin sodium

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
A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA	2025/08/24	NCT07140523	Not Applicable	Not yet recruiting	Sirius Therapeutics Co., Ltd.
Dimolegin® (60 mg) Given Once Daily in Patients Undergoing Total Hip or Knee Replacement Compared to Enoxaparin	2025/08/15	NCT07124819	Not Applicable	Completed	Avexima Diol LLC
Edoxaban Steady-State PK/PD in Adults With Nephrotic Syndrome	2025/08/11	NCT07116239	Not Applicable	Not yet recruiting	Peking University People's Hospital
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults	2025/06/11	NCT07015905	Phase 3	Recruiting	Regeneron Pharmaceuticals
Phase II Clinical Study of H001 Capsule in the Prevention of Venous Thromboembolism After Total Knee Arthroplasty	2025/05/09	NCT06963320	Phase 2	Recruiting	Livzon Pharmaceutical Group Inc.
Phase III Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty	2025/03/25	NCT06825416	Phase 3	Recruiting	Beijing Suncadia Pharmaceuticals Co., Ltd
Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis	2025/02/10	NCT06818279	Phase 2	Not yet recruiting	Institute of Liver and Biliary Sciences, India
The Effect of Prophylactic Anticoagulation on Major Bleeding Events in Hospitalized Chronic Kidney Disease and Lower Limb Fracture Patients.	2025/01/28	NCT06795698	Phase 2	Completed	Hospital Civil de Guadalajara
Rivaroxaban Versus Enoxaparin for Prophylaxis of Venous Thromboembolism in Bariatric Surgery	2024/11/14	NCT06689241	Not Applicable	Recruiting	Alexandria University
Efficacy of Aspirin in Preventing Venous Thromboembolism	2024/10/10	NCT06635317	Phase 4	Completed	Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Enoxaparin Sodium	Sandoz Inc	0781-3256	SUBCUTANEOUS	100 mg in 1 mL	1/23/2019
Enoxaparin Sodium	Fresenius Kabi USA, LLC	63323-607	SUBCUTANEOUS	60 mg in 0.6 mL	12/29/2021
Enoxaparin Sodium	Meitheal Pharmaceuticals Inc.	71288-438	SUBCUTANEOUS	150 mg in 1 mL	7/19/2022
Lovenox	Sanofi-Aventis U.S. LLC	0075-0626	SUBCUTANEOUS, INTRAVENOUS	300 mg in 3 mL	12/29/2021
Enoxaparin Sodium	Apotex Corp.	60505-0796	SUBCUTANEOUS	120 mg in 0.8 mL	7/21/2023
Enoxaparin Sodium	Cardinal Health 107, LLC	55154-3544	SUBCUTANEOUS	100 mg in 1 mL	1/31/2023
Enoxaparin Sodium	NorthStar Rx LLC	16714-066	SUBCUTANEOUS	150 mg in 1 mL	12/31/2020
Enoxaparin Sodium	NorthStar RxLLC	72603-175	SUBCUTANEOUS	40 mg in 0.4 mL	8/30/2023
Enoxaparin Sodium	Italfarmaco SpA	11797-763	INTRAVENOUS, SUBCUTANEOUS	150 mg in 1 mL	11/5/2022
Enoxaparin Sodium	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
Inhixa	Techdow Pharma Netherlands B.V.,Strawinskylaan 1143, Toren C-11,1077XX Amsterdam,Netherlands	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	Shenzhen Techdow Pharmaceutical Co., Ltd.	SIN16997P	INJECTION, SOLUTION	6000 IU (60 MG)/0.6 ML	5/7/2024
INHIXA Solution for Injection 2000 Anti-Xa IU (20MG)/0.2ML	Shenzhen Techdow Pharmaceutical Co., Ltd.	SIN16999P	INJECTION, SOLUTION	2000 IU (20 MG)/0.2 ML	5/7/2024
CLEXANE INJECTION 8000 IU (80mg)/0.8 ml	Sanofi Winthrop Industrie	SIN14094P	INJECTION	8000 IU (80mg)/0.8ml	2/6/2012
INHIXA Solution for Injection 4000 Anti-Xa IU (40MG)/0.4ML	Shenzhen Techdow Pharmaceutical Co., Ltd.	SIN16998P	INJECTION, SOLUTION	4000 IU (40 MG)/0.4 ML	5/7/2024
CLEXANE INJECTION 4000 IU (40mg)/0.4 ml	Sanofi Winthrop Industrie	SIN14095P	INJECTION	4000 IU (40mg)/0.4 ml	2/6/2012
CLEXANE INJECTION 2000 IU (20mg)/0.2 ml	Sanofi Winthrop Industrie	SIN07668P	INJECTION	2000 iu (20 mg)/0.2 ml	9/13/1993
CLEXANE INJECTION 6000 IU (60mg)/0.6 ml	Sanofi Winthrop Industrie	SIN14096P	INJECTION	6000 iu (60mg)/0.6 ml	2/6/2012
INHIXA SOLUTION FOR INJECTION 8000 ANTI-Xa IU (80MG)/0.8ML	Shenzhen Techdow Pharmaceutical Co., Ltd	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	ROVI PHARMA INDUSTRIAL SERVICES, S.A. (Julián Camarillo)	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	ROVI PHARMA INDUSTRIAL SERVICES, S.A. (Julián Camarillo)	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
No NMPA approvals found for this drug.

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
EXARANE enoxaparin sodium 100mg/1mL solution for injection prefilled syringe	375491	Juno Pharmaceuticals Pty Ltd	Medicine	A	7/28/2023
EXARANE FORTE enoxaparin sodium 150mg/1mL solution for injection prefilled syringe with safety lock system	429096	Juno Pharmaceuticals Pty Ltd	Medicine	A	5/13/2024
CLEXANE enoxaparin sodium 40mg/0.4mL injection syringe	42962	Sanofi-Aventis Australia Pty Ltd	Medicine	A	2/12/1993
EXARANE FORTE enoxaparin sodium 120mg/0.8mL solution for injection prefilled syringe with safety lock system	429092	Juno Pharmaceuticals Pty Ltd	Medicine	A	5/13/2024
EXARANE enoxaparin sodium 40mg/0.4mL solution for injection prefilled syringe	375490	Juno Pharmaceuticals Pty Ltd	Medicine	A	7/28/2023
CLEXANE enoxaparin sodium 40mg/0.4mL injection syringe with automatic safety lock system	221718	Sanofi-Aventis Australia Pty Ltd	Medicine	A	7/10/2014
ENOXAPO enoxaparin sodium 150 mg/1.0 mL solution for injection syringe	210324	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	2/10/2020
EXARANE enoxaparin sodium 20mg/0.2mL solution for injection prefilled syringe with safety lock system	429094	Juno Pharmaceuticals Pty Ltd	Medicine	A	5/13/2024
ENOXAJECT enoxaparin sodium 40mg/0.4mL solution for injection syringe with safety lock system	423556	Pharmacor Pty Ltd	Medicine	A	2/17/2025
EXARANE enoxaparin sodium 40mg/0.4mL solution for injection prefilled syringe with safety lock system	429090	Juno Pharmaceuticals Pty Ltd	Medicine	A	5/13/2024

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
LOVENOX HP	sanofi-aventis canada inc	02378450	Solution - Subcutaneous	90 MG / 0.6 ML	N/A
REDESCA	Shenzhen Techdow Pharmaceutical Co., Ltd.	02509091	Solution - Subcutaneous , Intravenous	60 MG / 0.6 ML	4/9/2021
REDESCA	Shenzhen Techdow Pharmaceutical Co., Ltd.	02509075	Solution - Subcutaneous , Intravenous	30 MG / 0.3 ML	4/9/2021
INCLUNOX	Sandoz Canada, Inc.	02507552	Solution - Intravenous , Subcutaneous	100 MG / 1 ML	5/4/2021
ELONOX	fresenius kabi canada ltd	02532255	Solution - Intravenous , Subcutaneous	40 MG / 0.4 ML	3/9/2023
AXBERI HP	baxter corporation	02540037	Solution - Intravenous , Subcutaneous	150 MG / ML	10/15/2024
NOROMBY	Juno Pharmaceuticals Corp.	02506491	Solution - Intravenous , Subcutaneous	100 MG / ML	6/25/2021
NOROMBY HP	Juno Pharmaceuticals Corp.	02506505	Solution - Subcutaneous , Intravenous	120 MG / 0.8 ML	6/25/2021
LOVENOX	sanofi-aventis canada inc	02378426	Solution - Subcutaneous	60 MG / 0.6 ML	11/13/2012
INCLUNOX	Sandoz Canada, Inc.	02507536	Solution - Intravenous , Subcutaneous	60 MG / 0.6 ML	5/4/2021

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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• Regeneron's REGN7508 demonstrated superior efficacy to enoxaparin in preventing venous thromboembolism (VTE) after knee surgery, with a 7% VTE event rate compared to 21%. • REGN9933 showed non-inferiority to enoxaparin in VTE prevention post-knee surgery, offering a potential option for patients at high bleeding risk. • Both REGN7508 and REGN9933 exhibited robust antithrombotic effects with no clinically relevant bleeding observed in Phase 2 trials. • Regeneron plans to initiate Phase 3 trials for REGN7508 and REGN9933 in 2025, marking a significant step in developing safer anticoagulation therapies.

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