Drugs / Fondaparinux
Fondaparinux
also known as
Arixtra · fondaparinux sodium · Fondaparin sodium · Fondaparinox · Fondaparinux sodico · Fondaparinux sodique · Fondaparinux sodium for assay · Fondaparinux sodium identification · +8 more
Other / unclassified targets SERPINC1 via activation
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | ARIXTRA | — | 2003-06-17 – 2024-12-23 | fda.gov ↗ |
| Approved | EU (EMA) | Arixtra | — | 2002-03-20 | europa.eu ↗ |
| Approved | US (FDA) | ARIXTRA | — | 2001-12-07 | fda.gov ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT01121770 | May 2010 → Oct 2012 | impaired renal function disease | Duke University | Completed | No outcome recorded |
| Phase 1 | NCT00659399 | Jan 2008 → Sep 2010 | ovarian carcinoma | NYU Langone Health | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00476216 | Sep 2007 → Dec 2012 | non-small cell lung carcinoma, venous thromboembolism | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 1 | NCT00412464 | Sep 2006 → Jun 2009 | heparin-induced thrombocytopenia | Children's Hospital Los Angeles | Completed | No outcome recorded |
| Phase 1 | NCT00346879 | Aug 2006 → Dec 2008 | morbid obesity | Indiana University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 24 trials | ||||||
| Phase 2 | NCT00673439 | Nov 2007 → Sep 2011 | heparin-induced thrombocytopenia | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00436787 | Feb → Dec 2007 | pulmonary embolism, venous thromboembolism | University of Pittsburgh | Completed | No outcome recorded |
| Phase 2 | NCT00381888 | Jan 2007 → Jan 2009 | cervical cancer, endometrial cancer, fallopian tube cancer, ovarian cancer +4 | Masonic Cancer Center, University of Minnesota | Completed | No outcome recorded |
| Phase 2 | NCT00060554 | Apr 2003 → ? | coronary artery disorder, myocardial infarction | Schering-Plough | Withdrawn | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT00881088 | Apr 2009 → Apr 2013 | pulmonary embolism, venous thromboembolism | Red Cross Hospital Beverwijk | Unknown | Met primary |
| Phase 2/3 | NCT00531843 | Dec 2007 → Jun 2008 | venous thromboembolism | Mary Knudson, M.D. | Completed | No outcome recorded |
| Phase 314 trials · 4 met primary | ||||||
| Phase 3 | NCT02798471 | Mar 2017 → May 2022 | pulmonary embolism, venous thromboembolism | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00843492 | Dec 2008 → Jan 2010 | venous thromboembolism | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00911157 | Jun 2008 → Nov 2009 | venous thromboembolism | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00981409 | Jul 2007 → Dec 2008 | pulmonary embolism | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00493896 | Jul 2007 → Apr 2010 | venous thromboembolism | Eastern Virginia Medical School | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00539942 | Apr 2007 → Jun 2010 | venous thromboembolism | University of Alabama at Birmingham | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00423683 | Jan 2007 → Nov 2010 | cancer, venous thromboembolism | Northwell Health | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00320424 | Feb → Oct 2006 | venous thromboembolism | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00320398 | Jan → Jul 2006 | venous thromboembolism | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00328939 | May 2004 → ? | venous thromboembolism | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00064428 | Aug 2003 → Feb 2006 | thrombotic disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00139815 | Apr 2003 → Dec 2005 | thrombotic disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00038961 | Nov 2001 → Oct 2004 | venous thromboembolism | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00474591 | — | coronary restenosis | Hamilton Health Sciences Corporation | Unknown | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT04447378 | Sep 2017 → Jun 2018 | venous thromboembolism | National University of Malaysia | Completed | No outcome recorded |
| Phase 4 | NCT01727401 | Nov 2012 → Jul 2021 | thrombocytopenia | G. d'Annunzio University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01467583 | Nov 2011 → Nov 2013 | venous thromboembolism | Wayne State University | Completed | No outcome recorded |
| Phase 4 | NCT00909064 | Jun → Dec 2009 | — | Paul Di Cesare,MD | Completed | No outcome recorded |
| Phase 4 | NCT00927602 | Apr 2009 → Dec 2011 | impaired renal function disease | University of Insubria | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00603824 | Jan 2008 → Jul 2009 | heparin-induced thrombocytopenia | Methodist Healthcare - Memphis | Withdrawn | No outcome recorded |
| Phase 4 | NCT00377091 | Jun → Nov 2007 | pulmonary embolism | University of Minnesota | Withdrawn | No outcome recorded |
| Phase 4 | NCT00555438 | Jun 2007 → Oct 2008 | — | University Hospital of Saint-Etienne | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT01267305 | Jan 2011 → Apr 2013 | lung neoplasm, neoplasm of esophagus, venous thromboembolism | Shanghai Zhongshan Hospital | Completed | No outcome recorded |
| — | NCT00483600 | Aug 2007 → Aug 2008 | kidney disorder | Duke University | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00413504 | Apr 2006 → Jul 2007 | pulmonary embolism, venous thromboembolism | Brigham and Women's Hospital | Completed | No outcome recorded |
| Comparator or background therapy19 trials | ||||||
| Phase 0 | NCT00894283 Comparator | Jun 2009 → Sep 2013 | pulmonary embolism, vein disorder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT04368377 Background | Apr 2020 | COVID-19, respiratory failure, thrombotic disease, viral pneumonia | University of Milan | Completed | No outcome recorded |
| Phase 2 | NCT00911300 Comparator | Aug 2009 → Sep 2011 | atrial fibrillation | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT07299695 Comparator | Jan 2026 → Jun 2028 expected | idiopathic pulmonary fibrosis | Argyrios Tzouvelekis | Recruiting | No outcome recorded |
| Phase 3 | NCT07228663 Comparator | Dec 2025 → Jul 2027 expected | venous thromboembolism | McMaster University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06370273 Comparator | Nov 2024 → Aug 2028 expected | thrombotic disease | Queen Mary University of London | Recruiting | No outcome recorded |
| Phase 3 | NCT01499953 Comparator | Apr 2012 → May 2016 | thrombophlebitis | GWT-TUD GmbH | Completed | Met primary |
| Phase 3 | NCT01857583 Comparator | Mar → Dec 2012 | venous thromboembolism | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00464087 Comparator | Jun 2007 → Nov 2010 | acute coronary syndrome | Medstar Health Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT00443053 Comparator | Mar 2007 → Jul 2009 | thrombophlebitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT06710184 Comparator | May 2025 → Jan 2029 expected | acute subendocardial myocardial infarction | University of Aarhus | Recruiting | No outcome recorded |
| Phase 4 | NCT05001776 Comparator | Aug 2021 → Dec 2023 | thrombophlebitis | National Medical Research Center for Therapy and Preventive Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01809054 Comparator | Apr 2012 → Feb 2013 | — | LifeBridge Health | Completed | No outcome recorded |
| Phase 4 | NCT00790907 Background | Feb 2009 → May 2010 | acute coronary syndrome | GlaxoSmithKline | Completed | Missed primary |
| — | NCT02744092 Comparator | Dec 2016 → Oct 2020 | cancer, pulmonary embolism, thrombotic disease, venous thromboembolism | Alliance Foundation Trials, LLC. | Completed | No outcome recorded |
| — | NCT00789399 Comparator | Nov 2009 → Sep 2013 | venous thromboembolism | Prairie Education and Research Cooperative | Terminated | No outcome recorded |
| — | NCT00767559 Comparator | Nov 2008 → Oct 2011 | pulmonary embolism | The New England Baptist Hospital | Unknown | No outcome recorded |
| — | NCT00521885 Comparator | Sep 2007 → Sep 2009 | venous thromboembolism | Lehigh Valley Hospital | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00256100 Comparator | Jun 2004 → Dec 2007 | kidney failure | Melbourne Health | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2018-11-16 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Abacavir & Lamivudine Tablets and Fondaparinux Sodium Injection zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Abacavir and Lamivudine Tablets USP, 600 mg/300 mg (US RLD – EPZICOM), and Fondaparinux Sodium Injection USP, 2.5 mg/0.5 mL, 5 mg/0.4 mL 7.5 mg/ 0.6 mL and 10 mg/0.8 mL single-dose (US RLD – ARIXTRA). |
| 2010-09-29 | GlaxoSmithKline | Regulatory GlaxoSmithKline receives EU approval for a new therapeutic indication for Arixtra® (fondaparinux) gsk.com ↗
GlaxoSmithKline (GSK) confirmed today that the European Commission (EC) has granted an amendment of their marketing authorisation for their anti-clotting agent (antithrombotic) Arixtra® (fondaparinux) in the European Union for a new therapeutic indication. |
| 2010-07-22 | GlaxoSmithKline | Regulatory GSK receives CHMP positive opinion for a new indication for Arixtra gsk.com ↗ |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-11-16 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Abacavir & Lamivudine Tablets and Fondaparinux Sodium Injection zyduslife.com ↗ |
| 2010-09-29 | GlaxoSmithKline | GlaxoSmithKline receives EU approval for a new therapeutic indication for Arixtra® (fondaparinux) gsk.com ↗ |
| 2010-07-22 | GlaxoSmithKline | GSK receives CHMP positive opinion for a new indication for Arixtra gsk.com ↗ |
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fondaparinux | “Fondaparinux, a synthetic, nonheparin drug, has shown promise in reducing VTE in orthopaedic patients, but has not previously been studied in trauma patients.” PMID 19854398 ↗ Sep 200945“Prophylactic-dose anticoagulation - low molecular weight heparin or fondaparinux - throughout hospitalization.” NCT07299695 ↗ “Fondaparinux” NCT02798471 ↗ |
| Known as | Arixtra | “A Pilot Study to Determine the Feasibility of Conducting a Randomized Clinical Trial Comparing Fondaparinux Sodium (Arixtra) Once Daily With Enoxaparin (Lovenox®) Twice Daily...” NCT00894283 ↗10“Fondaparinux sodium (Arixtra) is an FDA- approved medication used in the prevention of deep venous thrombosis (DVT) at the time of orthopedic or abdominal surgery, as well as...” NCT00436787 ↗ “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...” NCT00060554 ↗ “Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis” NCT00443053 ↗ “The purpose of this study is to determine a preventative dose of study drug, Arixtra® for patients with kidney disease.” NCT01121770 ↗ “Treatment will consist of daily injections of pharmacy prepared syringes of Arixtra (fondaparinux sodium) 2.5mg.” NCT00539942 ↗ |
| Known as | Fondaparin sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201202 ↗ |
| Known as | Fondaparinox | “Arixtra (Fondaparinox) 2.5 mg SC Daily” NCT00521885 ↗ |
| Known as | Fondaparinux sodico | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201202 ↗ |
| Known as | Fondaparinux sodique | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201202 ↗ |
| Known as | fondaparinux sodium | “A Pilot Study to Determine the Feasibility of Conducting a Randomized Clinical Trial Comparing Fondaparinux Sodium (Arixtra) Once Daily With Enoxaparin (Lovenox®) Twice Daily...” NCT00894283 ↗8“Fondaparinux sodium (Arixtra) is an FDA- approved medication used in the prevention of deep venous thrombosis (DVT) at the time of orthopedic or abdominal surgery, as well as...” NCT00436787 ↗ “This clinical trial will assess the pharmacokinetics and safety of the novel anticoagulant, fondaparinux sodium (Arixtra) in pediatric patients with thromboembolism.” NCT00412464 ↗ “Hip Fracture Study of GSK576428 (Fondaparinux Sodium)” NCT00320424 ↗ |
| Known as | Fondaparinux sodium for assay | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201202 ↗ |
| Known as | Fondaparinux sodium identification | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201202 ↗ |
| Known as | GSK576428 | “Hip Fracture Study of GSK576428 (Fondaparinux Sodium)” NCT00320424 ↗ |
| Known as | IC-851589 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201202 ↗ |
| Known as | ORG 31540 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201202 ↗ |
| Known as | ORG-31540 FREE ACID | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201202 ↗ |
| Known as | Quixidar | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201202 ↗ |
| Known as | SR 90107A | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201202 ↗ |
| Known as | SR 90107A DECASODIUM SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201202 ↗ |
| Known as | SR 901107A | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201202 ↗ |
| Action | Activate | “Antithrombin-III activator” CHEMBL1201202 ↗ |
| Action | Inhibit | “fondaparinux, a factor Xa inhibitor” PMID 16537725 ↗ Mar 2006 |
| Modality | Other / unclassified | “a fully synthetic pentasaccharide” NCT00659399 ↗ |
| Route | Subcutaneous | “Thereafter a once daily subcutaneous injection of either fondaparinux 2.5mg or placebo was to be administered up to Day 7 ±2.” NCT00038961 ↗ |
| Target | SERPINC1 | “Antithrombin-III activator” CHEMBL1201202 ↗ |