CLINICAL TRIALS PROFILE FOR ENOXAPARIN SODIUM

All Clinical Trials for enoxaparin sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00077753 ↗	EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization	Completed	Sanofi	Phase 4	2002-02-01	Primary objective: - To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd Secondary objectives: - To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis - To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study - To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes: - Major and minor hemorrhage - Heparin induced thrombocytopenia - Serious adverse events - To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.
NCT00077805 ↗	PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)	Completed	Sanofi	Phase 4	2003-08-01	Primary objective: - To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 ± 4 days following acute ischemic stroke. Secondary objectives: - To compare the incidence of VTE between the 2 treatment groups at 30, 60, and 90 days from the time of randomization - To compare neurologic outcomes between the 2 treatment groups, including incidence of stroke recurrence, rate of stroke progression, and patient functional status, during the 10 ± 4 days of treatment, and after 30, 60, and 90 days from the time of randomization - To evaluate the safety of using enoxaparin compared to UFH for VTE prevention in patients following acute ischemic stroke
NCT00077818 ↗	Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome (RESCUE)	Completed	Sanofi	Phase 4	2002-06-01	The purpose of this study is to determine the efficacy and safety of enoxaparin compared to unfractionated heparin (UFH) for patients diagnosed with Acute Coronary Syndrome (ACS) in the emergency department (ED). Efficacy is assessed by using a composite score consisting of 30-day all-cause mortality, non-fatal myocardial infarction (MI) and recurrent angina requiring revascularization.
NCT00077844 ↗	Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI) Patients, an International Randomized Evaluation (STEEPLE)	Completed	Sanofi	Phase 2/Phase 3	2004-01-01	The purpose of this study is to evaluate the efficacy and safety of intravenous enoxaparin versus intravenous unfractionated heparin (UFH) in patients undergoing non-emergent PCI, as assessed by measuring the incidence of non-coronary artery bypass graft (CABG) major and minor bleeding.
NCT00191724 ↗	Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study	Completed	Eli Lilly and Company	Phase 2	2004-09-01	An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium.
NCT00232271 ↗	The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.	Terminated	National Heart Foundation, Australia	Phase 4	2005-08-01	The purpose of this study is to assess the effect of the anticoagulant(blood thinner) Clexane on the development of leg clots following electrophysiology studies (EPS) and or radiofrequency ablation (RFA). People who suffer heart palpitations will sometimes need hospital admission to undergo an electrophysiology study ( and or a Radiofrequency Ablation)in order to diagnose and or treat their condition. Radiofrequency ablation is a procedure to stop abnormal heart rhythms. EPS/RFA studies require the puncture of the leg veins . Previous experience has shown that following the puncture of leg veins there is a small risk of developing a blood clot in the leg. It is not known whether giving blood thinners (anticoagulants) after the procedure will decrease this risk Enoxaparin Sodium (Clexane) is an anticoagulant used extensively and safely following bone (Orthopaedic) surgery to prevent blood clots from developing in the legs

Clinical Trial Conditions for enoxaparin sodium

Condition Name

Condition Name for enoxaparin sodium
Intervention	Trials
Venous Thromboembolism	16
Deep Vein Thrombosis	3
Myocardial Infarction	2
Arthroplasty, Replacement, Hip	2

Condition MeSH

Condition MeSH for enoxaparin sodium
Intervention	Trials
Thromboembolism	21
Venous Thromboembolism	19
Venous Thrombosis	6
Thrombosis	6

Clinical Trial Locations for enoxaparin sodium

Trials by Country

Trials by Country for enoxaparin sodium
Location	Trials
United States	28
Canada	10
Russian Federation	9
Mexico	8
Italy	8

Trials by US State

Trials by US State for enoxaparin sodium
Location	Trials
New Jersey	7
Ohio	3
Pennsylvania	2
California	2
Arizona	1

Clinical Trial Progress for enoxaparin sodium

Clinical Trial Phase

Clinical Trial Phase for enoxaparin sodium
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	17
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for enoxaparin sodium
Clinical Trial Phase	Trials
Completed	35
Recruiting	4
Terminated	4

Clinical Trial Sponsors for enoxaparin sodium

Sponsor Name

Sponsor Name for enoxaparin sodium
Sponsor	Trials
Sanofi	16
Daiichi Sankyo Co., Ltd.	4
Dana-Farber Cancer Institute	1

Sponsor Type

Sponsor Type for enoxaparin sodium
Sponsor	Trials
Industry	32
Other	31

Enoxaparin sodium Market Analysis and Financial Projection

Enoxaparin Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Enoxaparin sodium, a low molecular weight heparin (LMWH), is a crucial anticoagulant used to prevent and treat venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). This article provides an update on recent clinical trials, market analysis, and projections for enoxaparin sodium.

Clinical Trials Update

Aspirin vs Enoxaparin in Post-Surgery Patients

A significant clinical trial published in JAMA 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 between April 2019 and December 2020.

• Key Findings: The trial showed that enoxaparin was significantly superior to aspirin in preventing symptomatic VTE. The symptomatic VTE rate within 90 days of surgery was 3.45% in the aspirin group and 1.82% in the enoxaparin group, with an estimated difference of 1.97% (95% CI, 0.54%-3.41%)[1].

• Implications: This study underscores the efficacy of enoxaparin over aspirin in post-surgical VTE prevention, highlighting its importance in clinical practice.

Market Analysis

Current Market Size and Growth

The global enoxaparin sodium market has been experiencing robust growth driven by increasing incidence of thromboembolic disorders, an aging population, and rising obesity rates.

• Market Size: As of 2023, the global enoxaparin sodium market was valued at US$ 3315 million. It is projected to reach US$ 5415 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.1% during the forecast period 2024-2030[2][3].

• Regional Dominance: Europe is the largest market for enoxaparin sodium, accounting for nearly 60% of the global market share. Emerging markets, particularly in the Asia-Pacific and Latin America regions, are also expected to contribute significantly to the market growth as healthcare infrastructure improves[2][3].

Key Players and Market Share

The market is dominated by several key players, with Sanofi being the largest manufacturer, holding approximately 42% of the global market share. Other significant players include Techdow (Hepalink), Teva, Nanjing King-friend, Rovi, Fresenius Kabi, and Sandoz (Novartis)[2].

• Product Types: The market is segmented by product types, with 60 mg/0.6mL being the dominant form, accounting for 29% of the market share[2].

Market Projections

Drivers of Growth

Several factors are driving the growth of the enoxaparin sodium market:

• Increasing Incidence of Thromboembolic Disorders: The rising incidence of DVT and PE, particularly in an aging population and those with obesity, is a significant driver. Approximately 900,000 individuals in the United States experience DVT or PE each year, leading to thousands of fatalities[3].

• Advancements in Drug Formulations and Delivery: Innovations such as pre-filled syringes and auto-injectors have improved patient compliance and reduced the burden on healthcare providers, making treatment more accessible[3].

• Biosimilars and Competitive Landscape: The introduction of biosimilars is expected to increase competition and reduce costs, making anticoagulation therapies more affordable and accessible to a broader patient population[3].

Challenges and Opportunities

Despite the growth potential, the market faces several challenges and opportunities:

• Challenges: The market is subject to regulatory approvals, patent expirations, and the need for continuous innovation to stay competitive.

• Opportunities: Collaborations between pharmaceutical companies, research institutions, and healthcare providers are becoming more common, focusing on clinical trials, research, and the development of new formulations. Emerging markets offer significant growth opportunities as healthcare infrastructure improves[3][5].

Future Scope and Trends

Emerging Markets

Emerging markets, particularly in the Asia-Pacific and Latin America regions, represent a unique opportunity for growth. As healthcare infrastructure improves in these regions, the demand for anticoagulant therapies is expected to surge[3][5].

Innovations in Drug Delivery

Recent innovations in drug delivery systems, such as pre-filled syringes and auto-injectors, have enhanced patient outcomes and are expected to continue driving market growth. These advancements make treatment more accessible and improve patient compliance[3].

Biosimilars and Generic Versions

The rise of biosimilars and generic versions of enoxaparin sodium is expected to increase competition, reduce costs, and expand access to essential medications. This shift is particularly beneficial in making anticoagulation therapies more affordable for a broader patient population[3].

Key Takeaways

• Clinical Efficacy: Enoxaparin sodium has been proven to be significantly superior to aspirin in preventing symptomatic VTE in post-surgical patients.
• Market Growth: The global enoxaparin sodium market is projected to grow at a CAGR of 7.1% from 2024 to 2030, driven by increasing incidence of thromboembolic disorders and advancements in drug formulations.
• Regional Dominance: Europe is the largest market, but emerging markets in Asia-Pacific and Latin America offer significant growth opportunities.
• Innovations: Advancements in drug delivery systems and the rise of biosimilars are key drivers of market growth.

FAQs

What is the current market size of the global enoxaparin sodium market?

The global enoxaparin sodium market was valued at US$ 3315 million in 2023[2].

What is the projected growth rate of the enoxaparin sodium market from 2024 to 2030?

The market is expected to grow at a CAGR of 7.1% from 2024 to 2030[2].

Which region dominates the enoxaparin sodium market?

Europe is the largest market for enoxaparin sodium, accounting for nearly 60% of the global market share[2].

What are the key drivers of the enoxaparin sodium market growth?

Key drivers include the increasing incidence of thromboembolic disorders, advancements in drug formulations and delivery, and the rise of biosimilars[3].

Who are the major players in the enoxaparin sodium market?

Major players include Sanofi, Techdow (Hepalink), Teva, Nanjing King-friend, Rovi, Fresenius Kabi, and Sandoz (Novartis)[2].

Sources

1. JAMA Network: Effect of Aspirin vs Enoxaparin on Symptomatic Venous Thromboembolism After Hip or Knee Arthroplasty.
2. Valuates Reports: Global Enoxaparin Sodium Market Research Report 2024.
3. Market Research Intellect: Enoxaparin Sodium Market Size And Projection.
4. Synapse: Enoxaparin Sodium - Drug Targets, Indications, Patents.
5. OpenPR: Enoxaparin Sodium Market To Show Startling Growth During 2024-2027.