CLINICAL TRIALS PROFILE FOR ARIXTRA

All Clinical Trials for ARIXTRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00060554 ↗	A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)	Withdrawn	Schering-Plough	Phase 2	2003-04-01	The purpose of this research study is to obtain experience in the use of fondaparinux (Arixtra) as compared to heparin when administered to patients who undergo percutaneous coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and heparin are drugs that inhibit blood clotting.
NCT00256100 ↗	Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure.	Terminated	Melbourne Health	N/A	2004-06-01	The purpose of this project is to assess the safety and effectiveness of fondaparinux, a new drug to prevent blood clotting in the continuous dialysis machine used in intensive care patients who have kidney failure.
NCT00328939 ↗	ARIXTRA Local Study For Registration In China.	Completed	GlaxoSmithKline	Phase 3	2004-05-01	This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.
NCT00412464 ↗	Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis	Completed	Children's Hospital Los Angeles	Phase 1	2006-09-01	This study will evaluate the use of a blood thinner, fondaparinux, which is approved for use in adults (not in children) in a children aged 1-18 years. Subject with a blood clot (thrombosis) or heparin-induced thrombocytopenia who need to be on a blood thinner will be eligible to participate. Subjects will receive a once daily dose of fondaparinux followed by blood tests at 2, 4, 12, and 24 hours after the first dose in order to determine the proper dose for this age group. The hypothesis is that children receiving fondaparinux will be able to receive a once daily dose. The currently available alternative agent, enoxaparin, needs to be given twice daily. In addition, an evaluation of the safety of this medication will be made by assessing for side effects, especially bleeding.
NCT00423683 ↗	Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism	Terminated	GlaxoSmithKline	Phase 3	2007-01-01	The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without a inferior vena cava filter. The anticoagulation medication chosen will be Arixtra and it will be given once a day as an injection. Patients will be called at various intervals to monitor their signs and symptoms of new thromboembolisms.
NCT00423683 ↗	Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism	Terminated	Northwell Health	Phase 3	2007-01-01	The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without a inferior vena cava filter. The anticoagulation medication chosen will be Arixtra and it will be given once a day as an injection. Patients will be called at various intervals to monitor their signs and symptoms of new thromboembolisms.
NCT00424281 ↗	Effectiveness of Blood Clot Medication With Concomitant Blood Pressure Medication	Unknown status	GlaxoSmithKline		2007-02-01	Patients in intensive care units have higher risks for developing blood clots. Arixtra inhibits blood clot formation by binding with the blood clotting factor, Xa. Critical illnesses and, specifically, medications given in the ICU to increase arterial blood pressure (vasopressors) may impair the absorption of drugs like Arixtra that are given subcutaneously. The study will measure the levels of Arixtra in blood comparing those subjects who are and those subjects who are not on blood pressure medication.

Clinical Trial Conditions for ARIXTRA

Condition Name

Condition Name for ARIXTRA
Intervention	Trials
Venous Thromboembolism	6
Pulmonary Embolism	4
Heparin-Induced Thrombocytopenia	3
Thrombosis, Venous	3

Condition MeSH

Condition MeSH for ARIXTRA
Intervention	Trials
Thrombosis	12
Thromboembolism	12
Venous Thromboembolism	12
Venous Thrombosis	10

Clinical Trial Locations for ARIXTRA

Trials by Country

Trials by Country for ARIXTRA
Location	Trials
United States	62
Germany	26
Italy	10
China	7
Canada	7

Trials by US State

Trials by US State for ARIXTRA
Location	Trials
New York	5
California	4
Michigan	4
North Carolina	4
Texas	3

Clinical Trial Progress for ARIXTRA

Clinical Trial Phase

Clinical Trial Phase for ARIXTRA
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	7
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for ARIXTRA
Clinical Trial Phase	Trials
Completed	24
Terminated	8
Withdrawn	4

Clinical Trial Sponsors for ARIXTRA

Sponsor Name

Sponsor Name for ARIXTRA
Sponsor	Trials
GlaxoSmithKline	23
University of Alabama at Birmingham	2
Duke University	2

Sponsor Type

Sponsor Type for ARIXTRA
Sponsor	Trials
Other	37
Industry	26

Clinical Trials Update, Market Analysis, and Projection for ARIXTRA

Last updated: October 28, 2025

Introduction

ARIXTRA (fondaparinux sodium), an anticoagulant developed by GlaxoSmithKline (GSK), plays a significant role in preventing and treating venous thromboembolism (VTE). Its unique mechanism as a synthetic pentasaccharide offers targeted inhibition of factor Xa, making it a preferred choice in various clinical settings. This report provides an in-depth analysis of recent clinical trial updates, a comprehensive market overview, and projections for ARIXTRA's future trajectory.

Clinical Trials Update

Ongoing and Recent Clinical Trials

In recent years, ARIXTRA has maintained a strong investigational profile, with multiple clinical trials exploring expanded indications, dosing regimens, and efficacy in special populations:

• Extended Prophylaxis Post-Orthopedic Surgery: Several trials, including the FOAT (Fondaparinux in Orthopedic Arthroplasty Trial), assess the optimal duration of therapy to prevent postoperative VTE. Preliminary data suggest that extended prophylaxis beyond 7 days enhances efficacy with acceptable safety profiles.

• Use in Cancer-Associated Thrombosis: Emerging studies investigate fondaparinux's role in cancer-associated thrombosis (CAT). A phase II trial demonstrated comparable efficacy to low molecular weight heparins (LMWH), with potential benefits in subcutaneous administration and reduced bleeding risks.

• VTE Treatment in Special Populations: Research is ongoing into ARIXTRA's application among renal impairment and elderly patients, with early findings indicating safe and effective profiles comparable to existing therapies.

Clinical Trial Outcomes and Regulatory Status

While ARIXTRA's primary indications remain VTE prophylaxis in orthopedic and abdominal surgeries, recent trials foster expanded uses, prompting regulatory re-evaluations. Notably:

• European Regulatory Agencies have shown openness to label updates based on new efficacy data.
• Post-marketing studies continue to reinforce ARIXTRA’s safety profile, with hemorrhagic events remaining within acceptable limits.

Innovations and Formulation Development

GSK is exploring novel formulations, including biosimilar versions and fixed-dose combinations with other anticoagulants to improve adherence and therapeutic outcomes. Such innovations could influence market dynamics substantially.

Market Analysis

Current Market Landscape

ARIXTRA is positioned within the global anticoagulant market, which has experienced significant growth due to rising thromboembolic disease prevalence:

• Market Size & Growth: The global anticoagulants market was valued at approximately $14 billion in 2022 and is projected to grow at a CAGR of 7-9% through 2030 [1].
• Competitive Arena: ARIXTRA competes with LMWHs (e.g., enoxaparin), direct oral anticoagulants (DOACs) like rivaroxaban and apixaban, and vitamin K antagonists (e.g., warfarin). While DOACs dominate outpatient settings, fondaparinux retains strongholds in inpatient and surgical prophylaxis.

Market Drivers

• Growing Incidence of VTE & Atrial Fibrillation: As the aging population expands, so does the incidence of thrombotic conditions requiring anticoagulation.
• Shift Toward Subcutaneous Anticoagulants: Fondaparinux’s once-daily subcutaneous administration offers convenience over traditional therapies, supporting uptake.
• Guideline Endorsements: Recent clinical guidelines increasingly favor fondaparinux for specific indications, such as postoperative prophylaxis [2].

Market Challenges

• Pricing and Reimbursement: As a branded product, ARIXTRA faces price pressures, especially against generic LMWHs and DOACs.
• Competition from Oral Agents: The convenience and oral administration of DOACs limit fondaparinux’s use in outpatient settings.
• Safety Perception: Bleeding risk remains a concern; however, current data affirm ARIXTRA’s favorable safety profile when used appropriately.

Regional Market Dynamics

• North America: Dominates due to advanced healthcare infrastructure and high awareness. ARIXTRA remains a key surgical prophylaxis agent.
• Europe: Increasing adoption driven by updated clinical guidelines and regulatory support.
• Asia-Pacific: Rapid growth projected owing to aging populations, increased surgical procedures, and expanding healthcare access.

Future Market Projection

Forecast Overview

Based on current trends, ARIXTRA’s market is anticipated to maintain steady growth, with key factors influencing its trajectory:

• Growth Opportunities: Expansion into expanded indications such as cancer-associated thrombosis and extended prophylaxis, supported by ongoing trials.
• Oral Anticoagulant Competition: Despite competition, fondaparinux’s niche in specific inpatient settings remains strong.
• Potential Market Share Shifts: Introduction of biosimilars or fixed-dose combination products could disrupt pricing dynamics and expand clinical use.

Quantitative Projections

By 2030, the global fondaparinux market is projected to reach approximately $2.5 billion, growing at a CAGR of around 7% [1]. ARIXTRA's share within this market is expected to stabilize, driven by its established clinical profile and ongoing research into broader indications.

Strategic Considerations

• Regulatory Approvals: Navigating approvals for new indications and formulations will be vital.
• Manufacturing & Supply Chain: Ensuring cost-effective production and distribution resilience will influence market competitiveness.
• Partnerships & Collaborations: Collaborations with healthcare providers and payers could facilitate broader adoption.

Key Takeaways

• Clinical Trial Outlook: Ongoing studies are exploring new indications and formulations, potentially expanding ARIXTRA's clinical utility beyond its current scope.
• Market Position: ARIXTRA remains relevant in inpatient surgical prophylaxis, especially with favorable safety profiles, but faces stiff competition from DOACs in outpatient care.
• Growth trajectory: The market is expected to grow steadily, with ARIXTRA maintaining a solid niche, particularly in hospital settings and extended prophylaxis scenarios.
• Innovation & Expansion: Future success hinges on regulatory approvals for new uses, biosimilar development, and optimization of delivery methods.
• Strategic Focus: Emphasizing clinical evidence, improving cost-efficiency, and aligning with evolving treatment guidelines will be essential for sustained market presence.

FAQs

1. What are the primary clinical indications for ARIXTRA?
   ARIXTRA is mainly indicated for prophylaxis and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), particularly in orthopedic and abdominal surgeries, as well as in hospitalized medical patients.

2. How does ARIXTRA compare to DOACs in terms of safety and efficacy?
   While DOACs are favored for outpatient and long-term management due to oral administration, ARIXTRA’s injectable nature makes it preferable in inpatient settings. Clinical trials favor ARIXTRA regarding low bleeding risks in surgical prophylaxis, though head-to-head data vary.

3. Are there ongoing trials to expand ARIXTRA's indications?
   Yes, ongoing studies are evaluating fondaparinux in cancer-associated thrombosis, extended prophylaxis, and special populations such as renal impairment and elderly patients.

4. What factors could influence ARIXTRA’s market growth?
   The key factors include regulatory approval for new indications, competitive pricing, development of biosimilars, clinician preferences, and shifts in treatment guidelines favoring or disfavoring fondaparinux.

5. What are the main challenges for ARIXTRA’s future?
   Challenges encompass intense competition from oral anticoagulants, reimbursement constraints, safety concerns related to bleeding, and regulatory hurdles for new indications.

References

[1] MarketResearch.com, "Global Anticoagulants Market Analysis and Forecasts," 2022.
[2] American College of Chest Physicians (CHEST) Guidelines, 2022.