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fondaparinux sodium

Trade name: arixtra

Small moleculeapproved

Approved

Dec 7, 2001

Fondaparinux is a synthetic and specific inhibitor of activated Factor X (Xa). By selectively binding to antithrombin III (ATIII), fondaparinux sodium potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII. Neutralization of Factor Xa interrupts the blood coagulation cascade and thus inhibits thrombin formation and thrombus development. Fondaparinux is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): in patients undergoing hip fracture surgery, including extended prophylaxis; in patients undergoing hip replacement surgery; in patients undergoing knee replacement surgery; in patients undergoing abdominal surgery who are at risk for thromboembolic complications. The most serious adverse reactions reported with Fondaparinux are bleeding complications and thrombocytopenia. Agents that may enhance the risk of hemorrhage should be discontinued prior to initiation of therapy with Fondaparinux unless these agents are essential. — NCATS

Clinical trial activity

58 trials · 62 clinical orgs · 10 marketing orgs

Phase 1
6
Phase 2
29
Phase 3
25
Phase 4
13

Earliest trial started Nov 1, 2001 (NCT00038961)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Dec 7, 2001

    Sanofi-Synthelabo — Earliest FDA Approval

  3. Dec 7, 2001

    Mylan — NDA Secondary Org

  4. Dec 7, 2001

    Sanofi-Synthelabo — NDA Organization

  5. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jul 11, 2011

    Dr. Reddy's Laboratories — Marketing Organization

  2. Dec 26, 2017

    Eugia Pharma — Marketing Organization

  3. Dec 26, 2017

    Aurobindo Pharma — Marketing Organization

  4. May 15, 2018

    Hengrui Therapeutics, Inc. — Marketing Organization

  5. May 15, 2018

    Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. — Marketing Organization

  6. Nov 14, 2018

    ScinoPharm Taiwan — Marketing Organization

2020s

  1. Aug 19, 2024

    Hangzhou Zhongmei — Marketing Organization

  2. Dec 18, 2024

    BrightGene — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewDec 7, 2001

Chemistry & pharmacology

Loading structure…

SMILES

CO[C@H]1O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]2O[C@@H](C(=O)O)[C@@H](O[C@H]3O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]4O[C@H](C(=O)O)[C@@H](O[C@H]5O[C@H](COS(=O)(=O)O)[C@@H](O)[C@H](O)[C@H]5NS(=O)(=O)O)[C@H](O)[C@H]4O)[C@H](OS(=O)(=O)O)[C@H]3NS(=O)(=O)O)[C@H](O)[C@H]2OS(=O)(=O)O)[C@H](O)[C@H]1NS(=O)(=O)O
Mol. weight
1508.27 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • alpha-d-glucopyranoside, methyl o-2-deoxy-6-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-4)-o-beta-d-glucopyranuronosyl-(1-4)-o-2-deoxy-3,6-di-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-4)-o-2-o-sulfo-alpha-l-idopy
  • arixtra
  • arixtra
  • arixtra
  • arixtra
  • arixtra
  • avidin
  • fondaparin
  • fondaparin sodium
  • fondaparinux
  • fondaparinux
  • fondaparinux
  • fondaparinux
  • fondaparinux
  • fondaparinux
  • fondaparinux
  • fondaparinux
  • fondaparinux
  • fondaparinux sodium
  • fondaparinux sodium
  • fondaparinux sodium
  • fondaparinux sodium
  • fondaparinux sodium
  • fondaparinux sodium
  • fondaparinux sodium
  • fondaparinux sodium
  • fondaparinux sodium
  • fondaparinux sodium
  • gsk576428
  • heparin pentasaccharide
  • idrabiotaparinux sodium
  • methyl o-2-deoxy-6-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-4)-o-beta-d-glucopyranuronosyl-(1-4)-o-2-deoxy-3,6-di-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-4)-o-2-o-sulfo-alpha-l-idopyranuronosyl-(1-4)-2-deoxy-6-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranoside, decasodium salt
  • methyl o-2-deoxy-6-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-4)-o-beta-d-glucopyranuronosyl-(1-4)-o-2-deoxy-3,6-di-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-4)-o-2-o-sulfo-alpha-l-idopyranuronosyl-(1-4)-2-deoxy-6-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranoside, decasodium salt
  • natural heparin pentasaccharide
  • org 31540
  • org-31540
  • org-31540
  • org-31540
  • penta
  • quixidar
  • sr 90107
  • sr 90107a
  • sr-90107a
  • sr-90107a

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07228663Phase 3Dec 1, 2025Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, McMaster University
NCT06710184Phase 4Feb 1, 2025Aalborg University, Aarhus University, Danske Regioner, Horsens Hospital, Hospital of Southern Jutland, Randers Regional Hospital, University of Copenhagen, University of Southern Denmark, Viborg Regional Hospital
NCT06370273Phase 3Nov 12, 2024University of London
NCT05001776Phase 4Aug 16, 2021National Medical Research Center for Therapy and Preventive Medicine
NCT04406389Phase 4Jun 30, 2020Cornell University
NCT04368377Phase 2Apr 6, 2020Fondazione "Un Cuore per Milano" - a no profit foundation, University of Milan
NCT04447378Phase 4Sep 1, 2017National University of Malaysia
NCT02744092N/ADec 1, 2016Alliance Foundation Trials, Cancer Research Network
NCT01727401Phase 4Nov 1, 2012D'Annunzio University of Chieti–Pescara
NCT01809054Phase 4Apr 1, 2012Haemonetics Corporation, LifeBridge Health
NCT01499953Phase 3Apr 1, 2012Bayer, GWT-TUD GmbH
NCT01857583Phase 3Mar 1, 2012Daiichi Sankyo, Osaka Koseinenkin Hospital
NCT01467583Phase 4Nov 1, 2011GlaxoSmithKline, Wayne State University
NCT01267305N/AJan 1, 2011Fudan University
NCT01121770Phase 1May 1, 2010Duke University, GlaxoSmithKline
NCT00789399N/AOct 1, 2009American College of Phlebology, Prairie Education and Research Cooperative
NCT00911300Phase 2Aug 1, 2009GlaxoSmithKline
NCT00909064Phase 4Jun 1, 2009University of California, Davis
NCT00894283Early Phase 1 (Phase 1)Jun 1, 2009GlaxoSmithKline, Johns Hopkins University
NCT00927602Phase 4Apr 1, 2009University of Insubria
Showing 20 of 58 trials
Page 1 / 3

Organizations

Research & Development (62)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit291352001
SanofiFor profit6312001
Duke UniversityAcademic/Hospital3232003
McMaster UniversityAcademic/Hospital2112007
University of Alabama, BirminghamAcademic/Hospital2222007
University of ChicagoAcademic/Hospital2012003
University of MinnesotaAcademic/Hospital2222007
Aalborg UniversityAcademic/Hospital1012025
Aarhus UniversityAcademic/Hospital1112025
Alliance Foundation TrialsAcademic/Hospital1112016
American College of PhlebologyAcademic/Hospital1012009
American Society for Bariatric SurgeryAcademic/Hospital1012006
BayerFor profit1012012
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) NetworkAcademic/Hospital1012025
Cancer Research NetworkAcademic/Hospital1012016
Cornell UniversityAcademic/Hospital1112020
Daiichi SankyoFor profit1112012
D'Annunzio University of Chieti–PescaraAcademic/Hospital1112012
Danske RegionerGovernment1012025
Eastern Virginia Medical SchoolAcademic/Hospital1112007
62 organizations
Page 1 / 4

Marketing (11)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitMKTGDec 26, 2017
BrightGeneFor profitMKTGDec 18, 2024
Dr. Reddy's LaboratoriesFor profitMKTGJul 11, 2011
Eugia PharmaFor profitMKTGDec 26, 2017
Hangzhou ZhongmeiFor profitMKTGAug 19, 2024
Hengrui Therapeutics, Inc.For profitMKTGMay 15, 2018
Hengrui Therapeutics, Inc.For profitSYNMay 15, 2018
Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.For profitMKTGMay 15, 2018
MylanFor profitNDA2Dec 7, 2001
Sanofi-SynthelaboFor profitNDADec 7, 2001
ScinoPharm TaiwanFor profitMKTGNov 14, 2018