CLINICAL TRIALS PROFILE FOR LOVENOX

All Clinical Trials for LOVENOX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00371683 ↗	Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery	Completed	Bristol-Myers Squibb	Phase 3	2006-11-01	The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.
NCT00358735 ↗	Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)	Completed	Medical Compression Systems	N/A	2006-06-01	Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA surgery in comparison with LMWH.
NCT00375609 ↗	Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT)	Completed	Portola Pharmaceuticals	Phase 2	2006-05-01	Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the prophylaxis of venous thromboembolic events after unilateral knee replacement surgery.
NCT00289042 ↗	Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)	Completed	Sanofi	Phase 4	1999-12-01	SPECIFIC AIM: To test the safety and feasibility of using low molecular weight heparin (LMWH, enoxaparin sodium; Lovenox, Sanofi-Aventis) in lieu of unfractionated heparin (UFH) as antithrombotic therapy for patients in atrial fibrillation undergoing transesophageal echocardiography (TEE) guided chemical or electrical cardioversion to sinus rhythm. HYPOTHESIS: Early cardioversion from atrial fibrillation can be safely performed using a short-term anticoagulation strategy of low molecular weight heparin (Lovenox, Sanofi-Aventis) compared to unfractionated heparin, accompanied by a TEE examination prior to cardioversion. The use of LMWH with TEE will result in a safe, cost-effective, and possible efficacious approach to cardioversion of atrial fibrillation compared to UFH with TEE.
NCT00289042 ↗	Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)	Completed	The Cleveland Clinic	Phase 4	1999-12-01	SPECIFIC AIM: To test the safety and feasibility of using low molecular weight heparin (LMWH, enoxaparin sodium; Lovenox, Sanofi-Aventis) in lieu of unfractionated heparin (UFH) as antithrombotic therapy for patients in atrial fibrillation undergoing transesophageal echocardiography (TEE) guided chemical or electrical cardioversion to sinus rhythm. HYPOTHESIS: Early cardioversion from atrial fibrillation can be safely performed using a short-term anticoagulation strategy of low molecular weight heparin (Lovenox, Sanofi-Aventis) compared to unfractionated heparin, accompanied by a TEE examination prior to cardioversion. The use of LMWH with TEE will result in a safe, cost-effective, and possible efficacious approach to cardioversion of atrial fibrillation compared to UFH with TEE.

Clinical Trial Conditions for LOVENOX

Condition Name

Condition Name for LOVENOX
Intervention	Trials
Venous Thromboembolism	13
Pulmonary Embolism	10
Deep Vein Thrombosis	7
Venous Thrombosis	6

Condition MeSH

Condition MeSH for LOVENOX
Intervention	Trials
Thrombosis	24
Venous Thrombosis	23
Thromboembolism	20
Venous Thromboembolism	15

Clinical Trial Locations for LOVENOX

Trials by Country

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−

Trials by Country for LOVENOX
Location	Trials
United States	140
Mexico	16
India	15
Brazil	12
Canada	12

Trials by US State

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−

Trials by US State for LOVENOX
Location	Trials
California	10
New York	9
Texas	8
Massachusetts	7
Pennsylvania	6

Clinical Trial Progress for LOVENOX

Clinical Trial Phase

Clinical Trial Phase for LOVENOX
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for LOVENOX
Clinical Trial Phase	Trials
Completed	35
Terminated	12
Recruiting	9

Clinical Trial Sponsors for LOVENOX

Sponsor Name

Sponsor Name for LOVENOX
Sponsor	Trials
Sanofi	6
Bristol-Myers Squibb	4
GlaxoSmithKline	4

Sponsor Type

Sponsor Type for LOVENOX
Sponsor	Trials
Other	96
Industry	27
U.S. Fed	8

Lovenox (Enoxaparin Sodium): Clinical Trials, Market Analysis, and Projections

Introduction to Lovenox

Lovenox, also known as enoxaparin sodium, is a low molecular weight heparin (LMWH) used primarily for the prevention and treatment of deep vein thrombosis (DVT), pulmonary embolism, and other thrombotic conditions. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Recent Comparative Study: Aspirin vs Enoxaparin

A significant clinical trial published in 2022 compared the efficacy of aspirin versus enoxaparin in preventing symptomatic venous thromboembolism (VTE) in patients undergoing hip or knee arthroplasty. This cluster-randomized, crossover trial involved 31 hospitals in Australia and enrolled 9711 patients. The results showed that enoxaparin significantly outperformed aspirin in preventing VTE, with a symptomatic VTE rate of 1.82% in the enoxaparin group compared to 3.45% in the aspirin group. This difference was statistically significant, indicating that enoxaparin is superior to aspirin in this context[1].

Historical Trials and Approvals

Lovenox has a robust history of clinical trials that led to its FDA approvals. For instance, a Phase III clinical study conducted in the late 1990s demonstrated that enoxaparin significantly reduced the incidence of DVT following hip replacement surgery compared to a placebo. This study showed a DVT incidence of 7% in the enoxaparin group versus 20% in the placebo group, leading to FDA approval in February 1998[3].

Another notable trial, the ExTRACT-TIMI 25 study, involved 20,506 patients with ST-segment elevation acute myocardial infarction. This multicenter, randomized, double-blind study found that enoxaparin reduced the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction by 17% compared to unfractionated heparin[3].

Market Analysis

Current Market Size and Growth

The global low molecular weight heparin market, which includes Lovenox, is projected to grow significantly. As of 2025, the market size is estimated to be USD 4.72 billion, with a compound annual growth rate (CAGR) of 6.60% expected to reach USD 6.50 billion by 2030[5].

Regional Market Performance

North America currently holds the largest market share in the global LMWH market, while the Asia-Pacific region is expected to be the fastest-growing segment over the forecast period. This growth is driven by increasing healthcare expenditure, rising awareness of thrombotic conditions, and expanding access to anticoagulant therapies[5].

Impact of Generic and Biosimilar Competition

Despite its strong market position, Lovenox faces challenges from generic and biosimilar competition. For example, the approval of the first generic version of Lovenox by Momenta Pharmaceuticals and Sandoz in 2010 has impacted Sanofi's sales. Recently, Lovenox sales decreased by 13.9% to €262 million due to volume-based procurement in China and biosimilar competition, although this was partially offset by growth in other countries[2].

Market Projections

Future Growth Drivers

The market for Lovenox and other LMWHs is expected to be driven by several factors:

• Increasing Incidence of Thrombotic Conditions: The rising prevalence of conditions such as DVT and pulmonary embolism, particularly in aging populations, will drive demand for effective anticoagulants.
• Advancements in Healthcare Infrastructure: Improvements in healthcare systems, especially in emerging markets, will increase access to these medications.
• Research and Development: Ongoing research into new indications and dosing regimens for LMWHs will continue to support market growth[5].

Challenges and Opportunities

While generic and biosimilar competition poses a challenge, Sanofi and other manufacturers can leverage their strong R&D capabilities to develop new formulations or indications for Lovenox. For instance, studies like the PREVAIL study, which showed a significant reduction in VTE risk in acute ischemic stroke patients treated with Lovenox, can open up new market opportunities[4].

Safety and Side Effects

Monitoring and Contraindications

Lovenox, like other anticoagulants, comes with certain safety considerations. It is contraindicated in patients with active major bleeding, hypersensitivity to enoxaparin sodium, heparin, or pork products. Thrombocytopenia, including heparin-induced thrombocytopenia, is a potential side effect that requires close monitoring. If the platelet count falls below 100,000/mm³, Lovenox should be discontinued[4].

Key Takeaways

• Clinical Efficacy: Recent trials have reaffirmed the superiority of enoxaparin over aspirin in preventing VTE in surgical patients.
• Market Growth: The global LMWH market is expected to grow at a CAGR of 6.60% from 2025 to 2030, driven by increasing demand and expanding healthcare access.
• Challenges: Generic and biosimilar competition, along with safety considerations, are key factors influencing the market.
• Future Opportunities: Ongoing research and development, particularly into new indications and formulations, will be crucial for maintaining market share.

FAQs

What is the current market size of the global low molecular weight heparin market?

The global low molecular weight heparin market size is estimated to reach USD 4.72 billion in 2025[5].

Which region is expected to grow the fastest in the LMWH market?

The Asia-Pacific region is expected to be the fastest-growing segment over the forecast period[5].

What are the main indications for Lovenox?

Lovenox is indicated for the prevention and treatment of deep vein thrombosis, pulmonary embolism, and other thrombotic conditions, including ischemic complications of unstable angina and acute ST-segment elevation myocardial infarction[3].

What are the potential side effects of Lovenox?

Potential side effects include thrombocytopenia, heparin-induced thrombocytopenia, and major bleeding. Close monitoring of platelet counts is necessary[4].

How does Lovenox compare to aspirin in preventing VTE in surgical patients?

Recent clinical trials have shown that enoxaparin is significantly superior to aspirin in preventing symptomatic VTE in patients undergoing hip or knee arthroplasty[1].

Sources

1. Effect of Aspirin vs Enoxaparin on Symptomatic Venous Thromboembolism After Hip or Knee Arthroplasty: A Randomized Clinical Trial. JAMA, 2022.
2. Sanofi Q1: robust 7% sales growth driven by Dupixent and Beyfortus. Sanofi Press Release, 2024.
3. Lovenox (Enoxaparin Sodium) - Treatment for Deep Vein Thrombosis. Clinical Trials Arena, 2012.
4. New study shows LOVENOX® (enoxaparin sodium injection) is effective in reducing the risk of VTE in acute ischemic stroke patients. Sanofi US News, 2024.
5. Global Low Molecular Weight Heparin Market Size & Share Analysis. Mordor Intelligence, 2025.