Clinical Trials

Fondaparinux sodium has been evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4 protocols with diverse recruitment statuses, including completed, active, terminated, and withdrawn studies. Led by academic centers, health institutes, and pharmaceutical sponsors such as GlaxoSmithKline, this research primarily addresses thromboembolic disorders including deep vein thrombosis, pulmonary embolism, acute coronary syndromes, and heparin-induced thrombocytopenia. Additionally, several clinical trials have investigated fondaparinux in specific populations, such as patients with renal failure, morbid obesity, or advanced non-small cell lung cancer.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06710184 RECRUITING
NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI); Acute Myocardial Infarction (AMI)
University of Aarhus
 2025-05-01 PHASE4
NCT06370273 RECRUITING
Thrombosis; Injury Leg
Queen Mary University of London
 2024-11-12 PHASE3
NCT07228663 NOT_YET_RECRUITING
Hip Fracture Surgery; Cardiovascular Prevention; Venous Thromboembolism (VTE)
McMaster University
 2025-12-01 PHASE3
NCT05001776 COMPLETED
Superficial Vein Thrombosis; Endovenous Laser Ablation
National Medical Research Center for Therapy and Preventive Medicine
 2021-08-16 PHASE4
NCT01727401 TERMINATED
Medical Patient; Thrombocytopenia
G. d'Annunzio University
 2012-11 PHASE4
NCT02744092 COMPLETED
Cancer; Venous Thromboembolism; Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Blood Clot
Alliance Foundation Trials, LLC.
 2016-12-13
NCT04368377 COMPLETED
Pneumonia, Viral; Corona Virus Infection; Respiratory Failure; Embolism and Thrombosis
University of Milan
 2020-04-06 PHASE2
NCT04447378 COMPLETED
Thromboembolism in the Puerperium
National University of Malaysia
 2017-09-01 PHASE4
NCT01499953 COMPLETED
Superficial Vein Thrombosis
GWT-TUD GmbH
 2012-04 PHASE3
NCT01467583 COMPLETED
Venous Thromboembolism
Wayne State University
 2011-11 PHASE4
NCT00789399 TERMINATED
Deep Vein Thrombosis; Coronary Artery Bypass Surgery; Venous Thromboembolism
Prairie Education and Research Cooperative
 2009-11-19
NCT00894283 COMPLETED
Deep Venous Thrombosis; Pulmonary Embolism
Johns Hopkins University
 2009-06 EARLY_PHASE1
NCT01267305 COMPLETED
Lung Neoplasms; Esophageal Neoplasms; Venous Thromboembolism
Shanghai Zhongshan Hospital
 2011-01
NCT00881088 UNKNOWN
Deep Vein Thrombosis; Pulmonary Embolism
Red Cross Hospital Beverwijk
 2009-04 PHASE2; PHASE3
NCT00476216 COMPLETED
Non-Small Cell Lung Cancer; Venous Thromboembolism
University of Alabama at Birmingham
 2007-09 PHASE1
NCT01857583 COMPLETED
Venous Thromboembolism
Daiichi Sankyo Co., Ltd.
 2012-03 PHASE3
NCT01121770 COMPLETED
Renal Insufficiency
Duke University
 2010-05 PHASE1
NCT00927602 TERMINATED
Medical Patients; Renal Insufficiency
Università degli Studi dell'Insubria
 2009-04 PHASE4
NCT00767559 UNKNOWN
Pulmonary Embolism
The New England Baptist Hospital
 2008-11
NCT00673439 TERMINATED
Heparin-Induced Thrombocytopenia
University of Louisville
 2007-11 PHASE2
NCT00911300 COMPLETED
Fibrillation, Atrial
GlaxoSmithKline
 2009-08 PHASE2
NCT00464087 COMPLETED
Acute Coronary Syndromes
Medstar Health Research Institute
 2007-06 PHASE3
NCT00659399 WITHDRAWN
Ovarian Carcinoma
NYU Langone Health
 2008-01 PHASE1
NCT00539942 TERMINATED
Venous Thrombosis
University of Alabama at Birmingham
 2007-04 PHASE3
NCT00790907 COMPLETED
Acute Coronary Syndrome
GlaxoSmithKline
 2009-02 PHASE4
NCT00493896 TERMINATED
Venous Thromboembolism
Eastern Virginia Medical School
 2007-07 PHASE3
NCT00843492 COMPLETED
Thrombosis, Venous
GlaxoSmithKline
 2008-12 PHASE3
NCT00909064 COMPLETED
Total Knee Replacement
Paul Di Cesare,MD
 2009-06 PHASE4
NCT00911157 COMPLETED
Thrombosis, Venous
GlaxoSmithKline
 2008-06 PHASE3
NCT00521885 TERMINATED
Venous Thrombosis
Lehigh Valley Hospital
 2007-09
NCT00443053 COMPLETED
Thrombosis, Venous
GlaxoSmithKline
 2007-03 PHASE3
NCT00603824 WITHDRAWN
Heparin-Induced Thrombocytopenia
Methodist Healthcare - Memphis
 2008-01 PHASE4
NCT00412464 COMPLETED
Thrombosis; Heparin-induced Thrombocytopenia
Children's Hospital Los Angeles
 2006-09 PHASE1
NCT00381888 COMPLETED
Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Sarcoma; Thromboembolism; Vaginal Cancer; Vulvar Cancer
Masonic Cancer Center, University of Minnesota
 2007-01 PHASE2
NCT00346879 WITHDRAWN
Morbid Obesity
Indiana University
 2006-08 PHASE1
NCT00981409 COMPLETED
Embolism, Pulmonary
GlaxoSmithKline
 2007-07 PHASE3
NCT00555438 COMPLETED
Major Orthopaedic Surgery and Renal Impairment
Centre Hospitalier Universitaire de Saint Etienne
 2007-06 PHASE4
NCT00531843 COMPLETED
Venous Thromboembolism
Mary Knudson, M.D.
 2007-12 PHASE2; PHASE3
NCT00256100 TERMINATED
Renal Failure
Melbourne Health
 2004-06
NCT00377091 WITHDRAWN
Pulmonary Embolism
University of Minnesota
 2007-06 PHASE4
NCT00252005 COMPLETED
Deep-Vein Thrombosis
Bristol-Myers Squibb
 2005-11 PHASE2
NCT00436787 Completed
Venous Thrombosis|Pulmonary Embolism
University of Pittsburgh|GlaxoSmithKline
 2007-02 Phase 2
NCT00320424 COMPLETED
Thromboembolism
GlaxoSmithKline
 2006-02-16 PHASE3
NCT00320398 COMPLETED
Thrombosis, Venous
GlaxoSmithKline
 2006-01-30 PHASE3
NCT00064428 COMPLETED
Thromboembolism
GlaxoSmithKline
 2003-08 PHASE3
NCT00139815 COMPLETED
Thromboembolism
GlaxoSmithKline
 2003-04 PHASE3
NCT00038961 COMPLETED
Thromboembolism
GlaxoSmithKline
 2001-11 PHASE3
NCT00413504 COMPLETED
Deep Vein Thrombosis; Pulmonary Embolism
Brigham and Women's Hospital
 2006-04
NCT00333021 COMPLETED
Venous Thromboembolism
GlaxoSmithKline
 2006-05 PHASE3
NCT00483600 WITHDRAWN
Kidney Diseases
Duke University
 2007-08
NCT00474591 UNKNOWN
Coronary Bypass Graft Failure/Occlusion
Hamilton Health Sciences Corporation
 PHASE3
NCT00436787 COMPLETED
Venous Thrombosis; Pulmonary Embolism
University of Pittsburgh
 2007-02 PHASE2
NCT00060554 WITHDRAWN
Myocardial Infarction; Coronary Disease
Schering-Plough
 2003-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-04)

Check the Fondaparinux Sodium (Org 31540) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fondaparinux sodium selectively binds to antithrombin III, inducing a conformational change that dramatically accelerates the neutralization of activated coagulation Factor X (Factor Xa). By specifically inhibiting Factor Xa, the compound halts the enzymatic conversion of prothrombin to thrombin, thereby suppressing fibrin clot formation and demonstrating clinical efficacy in preventing and treating venous thromboembolism, deep vein thrombosis, and acute coronary syndromes.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.