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Arixtra

(fondaparinux)

ApprovedSmall molecule

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

This medication is a blood thinner that works by slowing down the blood's ability to clot. It is used to prevent blood clots in the legs (deep vein thrombosis) in certain situations and to treat existing blood clots in the legs or lungs.[2] Arixtra is currently approved and in use across 12 indications[4].[1]

Arixtra is one of 341 small molecule programs targeting Acute Coronary Syndrome. It is currently in Approved.

12

Indications

34

Total Trials

2

Active Trials

340

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Acute Coronary SyndromeApproved

Kidney DiseaseActive, not recruiting

ThromboembolismCompleted

Venous ThrombosisApproved

Atrial FibrillationApproved

Recurrent ThrombophlebitisActive, not recruiting

Morbid ObesityApproved

Renal InsufficiencyApproved

Ovarian CancerApproved

HemorrhageActive, not recruiting

Acute Coronary SyndromeApproved

Approved

Kidney DiseasePreclinical

Active, not recruiting

ThromboembolismApproved

Completed

Venous ThrombosisApproved

Approved

Atrial FibrillationApproved

Approved

Recurrent ThrombophlebitisApproved

Active, not recruiting

Morbid ObesityApproved

Approved

Renal InsufficiencyApproved

Approved

Ovarian CancerApproved

Approved

HemorrhagePreclinical

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

232 competitors in Ovarian Cancer

#DrugCompanyPhaseTrials

Arixtra

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Avastin

Gemzar

Johnson & Johnson

Keytruda

Hycamtin

Cytoxan

BBaxter Healthcare Corporation

Adriamycin

Opdivo

Bristol-Myers Squibb

Femara

Imfinzi

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Not yet recruiting

Hip Fracture

NCT07228663

Q3 2028

Phase 3Recruiting

Thrombosis

NCT06370273

Clinical

Trials by Indication[1]

Venous Thromboembolism5 trials

Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism

Completed· GSK logo

GSK··NCT01004939·120 enrolled

A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis

Terminated·PPrairie Education and Research Cooperative·N/A·NCT00789399·78 enrolled

Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia

Terminated·GG. d'Annunzio University·Phase 4·NCT01727401·7 enrolled

Show 2 more trials

Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients

Completed·JJohns Hopkins University·Phase 1·NCT00894283·198 enrolled

Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency

Terminated·UUniversità degli Studi dell'Insubria·Phase 4·NCT00927602·206 enrolled

Thrombocytopenia3 trials

Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)

Terminated·UUniversity of Louisville·Phase 2·NCT00673439·3 enrolled

Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)

Withdrawn·MMethodist Healthcare·Phase 4·NCT00603824

Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II

Completed· GSK logo

GSK··NCT01304238·195 enrolled

Hip Fracture2 trials

Hip Fracture Surgery Arterial and Venous Thrombotic Events Prevention

Not yet recruiting·MMcMaster University·Phase 3·NCT07228663·100 enrolled

Hip Fracture Study of GSK576428 (Fondaparinux Sodium)

Completed· GSK logo

GSK·Phase 3·NCT00320424·48 enrolled

Pulmonary Embolism2 trials

Arixtra PE Study- Outpatient Management of Stable Acute Pulmonary Embolism: Once Daily Subcutaneous Fondaparinux

Withdrawn·TThe Cleveland Clinic··NCT00378027

Fondaparinux as Monotherapy for DVT and/or Pulmonary Embolism

Completed·—·N/A·NCT00413504·30 enrolled

Thrombosis2 trials

Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis

Completed·—·Phase 1·NCT00412464·24 enrolled

Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a Multicentre Study Comprising Two Linked Open Label Phase III Randomised Controlled Trials Evaluating the Effectiveness and Cost Effectiveness of Different Methods of Pharmacological Prophylaxis for Patients With Temporary Lower Limb Immobilisation.

Recruiting·QQueen Mary University of London·Phase 3·NCT06370273·10,044 enrolled

17 more indications

Direct Oral Anticoagulants (DOACs)1 trial

Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer

Completed·AAlliance Foundation Trials, LLC.·N/A·NCT02744092·811 enrolled

Ovarian Carcinoma1 trial

Feasibility Study of Short Term Fondaparinux (Arixtra) in Chemotherapy-Pretreated Ovarian Carcinoma Patients at High Risk of Progression

Withdrawn·NNYU Langone Health·Phase 1·NCT00659399

Heart1 trial

Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm

Completed· GSK logo

GSK·Phase 2·NCT00911300·349 enrolled

Total Hip Replacement1 trial

Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)

Completed· GSK logo

GSK·Phase 3·NCT00320398·114 enrolled

Prophylaxis1 trial

Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

Terminated·—·Phase 3·NCT00493896·27 enrolled

Rivaroxaban1 trial

Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

Completed·GGWT-TUD GmbH·Phase 3·NCT01499953·472 enrolled

Obese1 trial

Study to Determine Effective Dosing of Fondaparinux in Obese Persons

Withdrawn·IIndiana University School of Medicine·Phase 1·NCT00346879

COVID-191 trial

Enhanced Platelet Inhibition in Critically Ill Patients With COVID-19

Completed·UUniversity of Milan·Phase 2·NCT04368377·5 enrolled

Coronary Artery Bypass1 trial

Fondaparinux to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery: The Fonda CABG Study

Unknown status·HHamilton Health Sciences Corporation·Phase 3·NCT00474591·100 enrolled

Function1 trial

Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

Withdrawn·—·N/A·NCT00483600

Complication1 trial

Prophylaxis of Thromboembolic Complications Trial: Thromboprophylaxis Needed in Below Knee Plaster Cast Immobilization for Ankle and Foot Fractures

Unknown status·—·Phase 2/3·NCT00881088·669 enrolled

Hemorrhage1 trial

The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery

Completed·SShanghai Zhongshan Hospital·N/A·NCT01267305·362 enrolled

Critically Ill Patients1 trial

Fondaparinux in Critically Ill Patients With Renal Failure

Completed·WWayne State University·Phase 4·NCT01467583·32 enrolled

Orthopedic Surgery1 trial

Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT01857583·80 enrolled

Knee Replacement Surgery1 trial

Prophylaxis Against DVTs After Primary Hip and Knee Replacement Surgery

Unknown status·TThe New England Baptist Hospital·N/A·NCT00767559·330 enrolled

Anticoagulant1 trial

Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery

Completed· GSK logo

GSK··NCT01444612·4,068 enrolled

Unspecified4 trials

Is Using Fondaparinux (Blood Thinner) to Treat Lung Clot Cheaper Than Traditional Therapy

Withdrawn·UUniversity of Minnesota·Phase 4·NCT00377091

Michelangelo - Oasis 5

Completed· GSK logo

GSK·Phase 3·NCT00139815·20,078 enrolled

Fondaparinux EU-RMP (Adherence)

Completed· GSK logo

GSK··NCT01406301·1 enrolled

Show 1 more trial

ARIXTRA® Adherence in SVT Patients.

Completed· GSK logo

GSK··NCT01691495·1 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 7, 2001

ARIXTRA

NDA NDA021345

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for fondaparinux. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Arixtra drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — fondaparinux compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for fondaparinux. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021345). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer's Upjohn has merged with Mylan to form Viatris Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Antithrombin-III Activator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

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