Drugs / Edoxaban
Edoxaban
also known as
DU-176b · Lixiana · D006 · edoxaban tosylate · DU-176 · Edoxaban (Savaysa) · Edoxaban tosilate · Roteas · +1 more
Small molecule targets F10 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed atrial fibrillation 1 milestone | |||||
| Filed | Japan (PMDA) | — | atrial fibrillation | 2020-09-11 | “submitted an supplemental application in Japan for an expanded approved usage or dosage for the anticoagulant, edoxaban(edoxaban tosilate hydrate)” daiichisankyo.com ↗ |
| Filed atrial fibrillation, familial, 17 3 milestones | |||||
| Filed | US (FDA) | SAVAYSA | atrial fibrillation, familial, 17 | 2014-01-08 | “the New Drug Application (NDA) for its investigational, oral, once-daily direct factor Xa-inhibitor SAVAYSATM (edoxaban) Tablets has been submitted to the U.S. Food and Drug...” daiichisankyo.com ↗ “Daiichi Sankyo has also filed for approval of once-daily edoxaban in both the U.S. and EU for the prevention of stroke in NVAF” daiichisankyo.com ↗ “Daiichi Sankyo Submits SAVAYSATM (edoxaban) Tablets New Drug Application to the U.S. FDA” daiichisankyo.com ↗ |
| Filed | EU (EMA) | — | atrial fibrillation, familial, 17 | 2014-01-07 | “today announced that the Marketing Authorization Application (MAA) for its investigational, oral, once-daily direct factor Xa-inhibitor edoxaban has been submitted to the...” daiichisankyo.com ↗ “Daiichi Sankyo has also filed for approval of once-daily edoxaban in both the U.S. and EU for the prevention of stroke in NVAF” daiichisankyo.com ↗ “Submits Edoxaban Marketing Authorization Application to the EMA” daiichisankyo.com ↗ |
| Filed | Other | — | atrial fibrillation, familial, 17 | — | “Daiichi Sankyo filed a New Drug Submission for edoxaban with the Health Products and Food Branch (HPFB) of Health Canada in August 2015.” daiichisankyo.com ↗ |
| Filed puerperal pulmonary embolism 1 milestone | |||||
| Filed | Japan (PMDA) | — | puerperal pulmonary embolism | 2010-04-06 | “submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan” daiichisankyo.com ↗ |
| Filed venous thromboembolism 2 milestones | |||||
| Filed | EU (EMA) | — | venous thromboembolism | 2014-01-07 | “Submits Edoxaban Marketing Authorization Application to the EMA” daiichisankyo.com ↗ |
| Filed | US (FDA) | SAVAYSA | venous thromboembolism | — | “Daiichi Sankyo Submits SAVAYSATM (edoxaban) Tablets New Drug Application to the U.S. FDA” daiichisankyo.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | SAVAYSA | — | 2019-08-09 – 2023-10-18 | fda.gov ↗ |
| Approved | EU (EMA) | Lixiana | — | 2015-06-19 | europa.eu ↗ |
| Approved | US (FDA) | SAVAYSA | — | 2015-01-08 | fda.gov ↗ |
Trials 85 · started per year
today
US approved 2015
EU approved 2015
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT07113054 | Sep 2025 overdue | — | Hyewon Chung | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06326138 | Mar 2024 | — | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | Withdrawn | No outcome recorded |
| Phase 1 | NCT05723510 | Mar → Jul 2023 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04867200 | Apr → May 2021 | — | Chong Kun Dang Pharmaceutical | Unknown | No outcome recorded |
| Phase 1 | NCT04673695 | Nov → Dec 2020 | — | Chong Kun Dang Pharmaceutical | Unknown | No outcome recorded |
| Phase 1 | NCT02303431 | Nov 2014 → Sep 2021 | venous thromboembolism | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT02047565 | Oct 2013 → May 2014 | hemorrhagic disease | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 217 trials · 2 met primary · 4 missed | ||||||
| Phase 2 | NCT05869591 | Jan 2024 → Jun 2026 overdue | cirrhosis of liver | Centre Hospitalier Universitaire Vaudois | Recruiting | No outcome recorded |
| Phase 2 | NCT05006287 | Oct 2022 → May 2024 | atrial fibrillation | St. Paul's Hospital, Canada | Unknown | No outcome recorded |
| Phase 2 | NCT05540587 | May 2022 → May 2024 | atrial fibrillation, mitral valve stenosis, stroke disorder | Sung-Hwan Kim | Unknown | No outcome recorded |
| Phase 2 | NCT03433235 | Jun 2018 → Apr 2020 | ischemic stroke | Jong Sung Kim | Completed | No outcome recorded |
| Phase 2 | NCT03489395 | Jan 2018 → Dec 2020 | atrial fibrillation | Raffaele De Caterina | Completed | No outcome recorded |
| Phase 2 | NCT03310021 | Aug 2017 → Aug 2019 | hemorrhagic disease | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02998905 | Apr 2017 → Oct 2019 | atrial fibrillation, intracerebral hemorrhage | Population Health Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT02207257 | Mar 2014 → Sep 2015 | — | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01802775 | Feb 2013 → Dec 2014 | peripheral arterial disease | Daiichi Sankyo | Completed | Missed primary |
| Phase 2 | NCT01662908 | Aug 2012 → Jan 2014 | venous thromboembolism | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT01203098 | Jul → Dec 2008 | osteoarthritis, hip, thrombotic disease, venous thromboembolism | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT00806624 | Oct 2007 → Oct 2008 | atrial fibrillation, stroke disorder | Daiichi Sankyo | Completed | Missed primary |
| Phase 2 | NCT00504556 | Jun 2007 → Jun 2008 | atrial fibrillation, thrombotic disease | Daiichi Sankyo | Completed | Missed primary |
| Phase 2 | NCT00829933 | Mar 2007 → Jul 2008 | atrial fibrillation | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT01203072 | Jul 2006 → Sep 2007 | venous thromboembolism | Daiichi Sankyo | Completed | Met primary |
| Phase 2 | NCT00398216 | May 2006 → Jun 2007 | thrombotic disease | Daiichi Sankyo | Completed | Met primary |
| Phase 2 | NCT00107900 | Jan → Dec 2005 | venous thromboembolism | Daiichi Sankyo | Completed | Missed primary |
| Phase 2/33 trials · 1 missed | ||||||
| Phase 2/3 | NCT05122455 | Sep 2021 → Jun 2024 | — | University of Sao Paulo | Completed | No outcome recorded |
| Phase 2/3 | NCT03570281 | Jun 2018 → May 2020 | — | Samsung Medical Center | Unknown | Missed primary |
| Phase 2/3 | NCT02221102 | Dec 2013 → Jun 2015 | cerebral infarction, ischemic disease | Xijing Hospital | Unknown | No outcome recorded |
| Phase 326 trials · 5 met primary · 3 missed | ||||||
| Phase 3 | NCT07454707 | Apr 2026 → Dec 2031 expected | ischemic stroke | Sunnybrook Health Sciences Centre | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06149533 | Nov 2023 → May 2026 overdue | cancer, venous thromboembolism | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05035277 | Dec 2021 → Jun 2026 | aortic valve stenosis | Oslo University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT04542408 | Nov 2020 → Sep 2022 | COVID-19 | University Medical Center Hamburg-Eppendorf | Completed | No outcome recorded |
| Phase 3 | NCT04045665 | Dec 2019 → Aug 2026 overdue | atrial fibrillation, hemorrhagic disease, stroke disorder | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 3 | NCT03961334 | Dec 2019 → Jan 2025 | ischemic stroke | University of Zurich | Unknown | No outcome recorded |
| Phase 3 | NCT04171726 | Aug 2019 → Jun 2023 | aortic valve stenosis | Erasmus Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT03996772 | Jun 2019 → May 2024 | atrial fibrillation, intracerebral hemorrhage | Imperial College London | Completed | Mixed |
| Phase 3 | NCT03395639 | May 2018 → Dec 2021 | heart disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT03153150 | Mar 2018 → Mar 2021 | atrial fibrillation, atrial flutter, intracerebral hemorrhage, subarachnoid hemorrhage | University of Edinburgh | Completed | Missed primary |
| Phase 3 | NCT03244319 | Dec 2017 → Sep 2019 | cardiac valvular defect | Yonsei University | Completed | No outcome recorded |
| Phase 3 | NCT02798471 | Mar 2017 → May 2022 | pulmonary embolism, venous thromboembolism | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT02943785 | Mar 2017 → Feb 2021 | atrial fibrillation | Daiichi Sankyo | Completed | Mixed |
| Phase 3 | NCT02942576 | Mar 2017 → Sep 2018 | atrial fibrillation | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Completed | No outcome recorded |
| Phase 3 | NCT02866175 | Feb 2017 → Jun 2019 | atrial fibrillation | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Completed | Met primary |
| Phase 3 | NCT02801669 | Aug 2016 → Dec 2019 | atrial fibrillation | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT02618577 | Feb 2016 → Dec 2022 | atrial tachycardia | Atrial Fibrillation Network | Terminated | Missed primary |
| Phase 3 | NCT02073682 | Jul 2015 → Sep 2017 | cancer, pulmonary embolism, venous thromboembolism | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT02072434 | Mar 2014 → Feb 2016 | atrial fibrillation | Daiichi Sankyo | Completed | Missed primary |
| Phase 3 | NCT01857583 | Mar → Dec 2012 | venous thromboembolism | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT01857622 | Nov 2011 → Jan 2013 | atrial fibrillation | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00986154 | Oct 2009 → Apr 2013 | pulmonary embolism, thrombotic disease, venous thromboembolism | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT01181167 | May 2009 → Jan 2010 | venous thromboembolism | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT01181102 | Mar → Sep 2009 | venous thromboembolism | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT00781391 | Nov 2008 → Apr 2013 | atrial fibrillation, stroke disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT01181141 | Oct 2008 → Aug 2009 | venous thromboembolism | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 421 trials · 4 met primary · 1 missed | ||||||
| Phase 4 | NCT07609654 | Jun 2026 → Jun 2029 expected | atrial fibrillation, intracerebral hemorrhage, ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06402851 | Dec 2024 → Dec 2026 expected | atrial fibrillation, chronic kidney disease | Hospital Sirio-Libanes | Recruiting | No outcome recorded |
| Phase 4 | NCT06401616 | May 2024 → Mar 2028 expected | atrial fibrillation | Odense University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04436978 | Jan 2023 → Oct 2027 expected | ST-elevation myocardial infarction, acute coronary syndrome, atrial fibrillation, atrial flutter +3 | St. Antonius Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05320627 | Mar 2022 → Aug 2024 | atrial fibrillation | China National Center for Cardiovascular Diseases | Completed | No outcome recorded |
| Phase 4 | NCT05292846 | Jan 2022 → Feb 2024 | coronary artery disorder, hemorrhagic disease | Hospital Universitario La Fe | Unknown | Met primary |
| Phase 4 | NCT04700826 | Jun 2021 → Dec 2027 expected | atrial fibrillation | University of Birmingham | Recruiting | No outcome recorded |
| Phase 4 | NCT03950076 | Sep 2019 → Jul 2026 | atrial fibrillation, intracerebral hemorrhage | Population Health Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT04072068 | Jun 2019 → Mar 2022 | cancer, venous thromboembolism | Italian Oncology Group for Clinical Research | Completed | No outcome recorded |
| Phase 4 | NCT03968393 | Jun 2019 → Dec 2028 expected | atrial fibrillation, stroke disorder | Population Health Research Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT03895502 | May 2019 → Jun 2023 | cancer or benign tumor, venous thromboembolism | Takeshi Morimoto | Completed | Met primary |
| Phase 4 | NCT03840291 | May 2019 → Oct 2023 | atrial fibrillation | Keimyung University Dongsan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03718559 | May 2019 → Nov 2023 | atrial fibrillation, intermediate coronary syndrome | Gi-Byoung Nam | Completed | Met primary |
| Phase 4 | NCT03666650 | Nov 2018 → Jan 2019 | blood coagulation disease | Turku University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03494530 | Jun 2018 → Dec 2021 | atrial fibrillation, hemorrhagic stroke, ischemic stroke | University of Alberta | Completed | No outcome recorded |
| Phase 4 | NCT03284827 | Mar 2018 → Oct 2021 | aortic valve stenosis | Duk-Woo Park, MD | Completed | Missed primary |
| Phase 4 | NCT03088072 | Mar 2017 → Nov 2018 | atrial fibrillation | Scripps Health | Unknown | No outcome recorded |
| Phase 4 | NCT03073850 | Feb 2017 → Dec 2019 | atrial fibrillation | Korea University Guro Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02666742 | Feb 2017 → May 2020 | stroke disorder, ventricular tachycardia | Kansas City Heart Rhythm Institute | Completed | Met primary |
| Phase 4 | NCT02567461 | Mar 2016 → Oct 2017 | coronary artery disorder | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT02561897 | Dec 2015 → Sep 2017 | atrial fibrillation | Electrophysiology Research Foundation | Terminated | No outcome recorded |
| Phase not applicable11 trials · 1 met primary | ||||||
| — | NCT07116239 | Sep 2025 → Feb 2026 overdue | nephrotic syndrome | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06864052 | Mar 2025 → Sep 2029 expected | atrial fibrillation, ischemic stroke | Ewha Womans University Seoul Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06285942 | Feb 2024 → Jan 2025 | atrial fibrillation | Azienda Ospedaliero Universitaria Maggiore della Carita | Unknown | No outcome recorded |
| — | NCT06057467 | Sep 2023 → Oct 2025 | atrial fibrillation, ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| — | NCT05419583 | Nov 2022 → Jun 2024 | myocardial infarction | University of Edinburgh | Completed | No outcome recorded |
| — | NCT05801068 | Aug 2020 → May 2024 overdue | atrial fibrillation, hemorrhagic disease | Seoul National University Hospital | Active not recruiting | No outcome recorded |
| — | NCT03759938 | Jun 2019 → May 2024 | atrial fibrillation, ischemic stroke | University College, London | Unknown | Met primary |
| — | NCT03642509 | Jan 2019 → Jan 2026 overdue | atrial fibrillation, stroke disorder | University of Aarhus | Recruiting | No outcome recorded |
| — | NCT04121767 | Dec 2017 → Jun 2020 | atrial fibrillation, blood coagulation disease | Samsung Medical Center | Completed | No outcome recorded |
| — | NCT03148457 | Nov 2017 → Dec 2022 | ischemic stroke | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| — | NCT02964949 | Jan 2017 → Oct 2018 | atrial fibrillation | Daiichi Sankyo | Completed | No outcome recorded |
| Comparator or background therapy32 trials | ||||||
| Phase 1 | NCT06372483 Background | Feb → Aug 2024 | blood coagulation disease | VarmX B.V. | Completed | No outcome recorded |
| Phase 1 | NCT05491460 Comparator | Jul 2022 → Dec 2023 | — | Doasense GmbH | Unknown | No outcome recorded |
| Phase 1 | NCT05152420 Background | Oct 2021 → Feb 2023 | blood coagulation disease | VarmX B.V. | Completed | No outcome recorded |
| Phase 1 | NCT03083704 Background | Feb → Sep 2017 | hemorrhagic disease | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04002011 Comparator | Mar 2022 → Jan 2023 | bleeding disorder, vascular-type | Laval University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02339415 Comparator | Jul 2015 → Sep 2018 | HIV infectious disease, blood coagulation disease | Hennepin Healthcare Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT03551743 Background | Dec 2012 → Sep 2015 | — | Portola Pharmaceuticals | Completed | Met primary |
| Phase 2/3 | NCT06900725 Comparator | Apr 2025 → Dec 2030 expected | atrial fibrillation, ischemic stroke | National Taiwan University Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06322953 Comparator | Mar 2025 → Dec 2027 expected | traumatic brain injury | Walton Centre NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 3 | NCT04284839 Comparator | Jul 2021 → Jun 2027 expected | — | Population Health Research Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT04730037 Comparator | Mar 2021 → Mar 2023 | chronic thromboembolic pulmonary hypertension | Kyushu University | Completed | No outcome recorded |
| Phase 3 | NCT04516941 Comparator | Jan 2021 → Aug 2022 | COVID-19 | Insel Gruppe AG, University Hospital Bern | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01924065 Comparator | Aug 2013 → Aug 2017 | atrial fibrillation, stroke disorder | Suleyman Demirel University | Completed | No outcome recorded |
| Phase 4 | NCT07852637 Comparator | Nov 2026 → Dec 2029 expected | venous thromboembolism | Samsung Medical Center | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06650501 Comparator | Jan 2026 → Jan 2030 expected | infective endocarditis, staphylococcal toxemia, staphylococcus aureus infection | McGill University Health Centre/Research Institute of the McGill University Health Centre | Recruiting | No outcome recorded |
| Phase 4 | NCT03129555 Comparator | Apr 2023 → Mar 2027 expected | pulmonary embolism, venous thromboembolism | Herlev and Gentofte Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03129490 Comparator | Apr 2023 → Oct 2027 expected | atrial fibrillation, atrial flutter | Herlev and Gentofte Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03568890 Comparator | Sep 2018 → Aug 2025 overdue | hemorrhagic disease, thrombotic disease, transient ischemic attack | Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03463317 Comparator | Feb 2018 → Nov 2024 | atrial fibrillation | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 4 | NCT02735902 Background | Jun 2017 → Feb 2023 | — | Nîmes University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03062319 Comparator | Apr 2017 → Jul 2023 | atherosclerosis, atrial fibrillation, ischemic stroke | National Hospital Organization Osaka National Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT02935855 Comparator | Sep 2015 → Apr 2019 | diabetes mellitus | University of Pavia | Completed | No outcome recorded |
| Phase 4 | NCT01962545 Background | Nov 2013 → May 2017 | atrial fibrillation, coronary artery disorder | Satoshi Shizuta | Completed | Missed primary |
| — | NCT07497893 Background | Dec 2026 → Nov 2029 expected | atrial fibrillation | Ewha Womans University Mokdong Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07583784 Comparator | Aug 2026 → Dec 2031 expected | ST-elevation myocardial infarction, atrial fibrillation | Chonnam National University Hospital | Recruiting | No outcome recorded |
| — | NCT07616414 Comparator | May → Dec 2026 expected | atrial fibrillation, thrombotic disease | Fu Wai Hospital, Beijing, China | Not yet recruiting | No outcome recorded |
| — | NCT04684212 Comparator | Jun 2024 | atrial fibrillation, stroke disorder | Brian O'Neill MD | Withdrawn | No outcome recorded Stop: Business |
| — | NCT05472766 Comparator | Nov 2022 → Mar 2024 | atrial fibrillation | Sunnybrook Health Sciences Centre | Terminated | No outcome recorded |
| — | NCT06449469 Background | May 2021 → Apr 2026 overdue | aortic valve stenosis | Rigshospitalet, Denmark | Active not recruiting | No outcome recorded |
| — | NCT03465735 Background | Jan 2017 → Aug 2019 | venous thromboembolism | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02744092 Comparator | Dec 2016 → Oct 2020 | cancer, pulmonary embolism, thrombotic disease, venous thromboembolism | Alliance Foundation Trials, LLC. | Completed | No outcome recorded |
| — | NCT01999179 Background | Jun 2014 → Apr 2019 | neoplasm, venous thromboembolism | Medical College of Wisconsin | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2020-09-11 | Daiichi Sankyo | Regulatory Daiichi Sankyo Submits Supplemental Application in Japan for Approval of Partial Changes in Usage or Dosage for Anticoagulant Edoxaban daiichisankyo.com ↗
Daiichi Sankyo Company Limited (hereinafter, Daiichi Sankyo) announced today that it submitted an supplemental application in Japan for an expanded approved usage or dosage for the anticoagulant, edoxaban(edoxaban tosilate hydrate), for elderly patients with non-valvular atrial fibrillation and high bleeding risk. |
| 2020-08-31 | Daiichi Sankyo | Results Daiichi Sankyo Announces Results of Phase 3 Clinical Trial for Anticoagulant Edoxaban (ELDERCARE-AF Study) daiichisankyo.com ↗
In the study, the primary endpoint of annual incidence of stroke and systemic embolism was 2.3% in the edoxaban arm and 6.7% in the placebo arm, demonstrating the superiority of edoxaban for the primary efficacy outcome. |
| 2019-09-04 | Daiichi Sankyo | Results Daiichi Sankyo Presents Positive Results of the ENTRUST-AF PCI Study of LIXIANA® (edoxaban) in Patients with Atrial Fibrillation daiichisankyo.com ↗
The study showed the edoxaban-based regimen is non-inferior compared with the VKA-based triple therapy regimen on the composite endpoint of major or clinically-relevant non-major bleeding over 12 months. |
| 2019-03-19 | Daiichi Sankyo | Results Daiichi Sankyo Presents Positive Results of the First Randomized, Controlled Trial of Uninterrupted Oral, Once-daily Lixiana® (edoxaban) in Atrial Fibrillation Patients Undergoing Catheter Ablation daiichisankyo.com ↗
Late-breaking data presented at EHRA 2019, the annual congress of the European Heart Rhythm Association, shows ELIMINATE-AF met primary efficacy and safety objectives, demonstrating low thromboembolic and bleeding event rates[1] |
| 2017-12-13 | Daiichi Sankyo | Results Once-Daily, Oral LIXIANA® (edoxaban) Met Primary Endpoint in Investigational Hokusai-VTE CANCER Study daiichisankyo.com ↗
Study met primary endpoint of non-inferiority in the recurrence of VTE or ISTH-defined major bleeding |
| 2017-11-15 | Daiichi Sankyo | Results New LIXIANA® sub-analysis from the ENGAGE AF-TIMI 48 trial presented at the American Heart Association Annual Scientific Sessions 2017 daiichisankyo.com ↗
A sub-analysis of the ENGAGE AF-TIMI 48 trial found that edoxaban had even greater reductions in ischaemic events compared to warfarin in patients with atrial fibrillation (AF) and coronary artery disease (CAD) |
| 2016-08-30 | Daiichi Sankyo | Results ENSURE-AF Data Support the Efficacy and Safety Profile of Daiichi Sankyo’s Once-Daily LIXIANA® in Patients with Atrial Fibrillation Undergoing Cardioversion daiichisankyo.com ↗
The results demonstrate that LIXIANA® may be an effective and safe alternative to conventional treatment with enoxaparin and a VKA (vitamin K antagonist), and may allow prompt cardioversion to be performed with TEE (transoesophageal echocardiography) |
| 2015-09-24 | Daiichi Sankyo | Regulatory UK’s NICE recommends once-daily LIXIANA® (edoxaban) for preventing stroke and systemic embolism in patients with non-valvular atrial fibrillation daiichisankyo.com ↗ |
| 2015-08-26 | Daiichi Sankyo | Regulatory UK’s NICE recommends once-daily LIXIANA® (edoxaban) for the treatment and prevention of recurrent deep vein thrombosis and pulmonary embolism in adults daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that NICE has issued its final recommendation for LIXIANA® (edoxaban) for the treatment and prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults. |
| 2015-06-25 | Daiichi Sankyo | Regulatory Daiichi Sankyo’s Once-Daily LIXIANA® (edoxaban) Approved in the EU for Stroke Prevention in Nonvalvular Atrial Fibrillation and for the Treatment and Prevention of Recurrent DVT and PE daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Commission (EC) has granted Marketing Authorisation for LIXIANA® (edoxaban), an oral, once-daily selective factor Xa-inhibitor, for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA) as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent D |
| 2015-04-27 | Daiichi Sankyo | Regulatory Daiichi Sankyo’s Once-Daily Lixiana® (edoxaban) Receives Positive CHMP Opinion for the Prevention of Stroke and Systemic Embolism in Non-Valvular Atrial Fibrillation and for the Treatment and Prevention of Recurrent Venous Thromboembolism in Europe daiichisankyo.com ↗
The European Committee for Medicinal Products for Human Use recommended approval of once-daily Lixiana® |
| 2015-04-15 | Daiichi Sankyo | Regulatory Daiichi Sankyo’s Once-Daily Lixiana® (edoxaban) Approved for the Prevention of Stroke and Systemic Embolism in Non-Valvular Atrial Fibrillation and for the Treatment and Prevention of Recurrent Venous Thromboembolism in Switzerland daiichisankyo.com ↗
Daiichi Sankyo’s Once-Daily Lixiana® (edoxaban) Approved for the Prevention of Stroke and Systemic Embolism in Non-Valvular Atrial Fibrillation and for the Treatment and Prevention of Recurrent Venous Thromboembolism in Switzerland |
| 2015-01-09 | Daiichi Sankyo | Regulatory U.S. FDA Approves Daiichi Sankyo’s Once-Daily SAVAYSA™ (edoxaban) Tablets for Reduction of Stroke Risk in Non-Valvular Atrial Fibrillation and for the Treatment of Venous Thromboembolism daiichisankyo.com ↗
U.S. FDA Approves Daiichi Sankyo’s Once-Daily SAVAYSA™ (edoxaban) Tablets for Reduction of Stroke Risk in Non-Valvular Atrial Fibrillation and for the Treatment of Venous Thromboembolism |
| 2014-10-31 | Daiichi Sankyo | Regulatory U.S. FDA Cardiovascular and Renal Drugs Advisory Committee Makes Recommendation on Daiichi Sankyo’s Once-Daily SAVAYSA™ (edoxaban) for the Reduction in Risk of Stroke and Systemic Embolic Events in Patients with Non-Valvular Atrial Fibrillation daiichisankyo.com ↗ |
| 2014-09-26 | Daiichi Sankyo | Regulatory Daiichi Sankyo Receives Approval for Additional Indications of LIXIANA® (edoxaban) in Japan daiichisankyo.com ↗
Daiichi Sankyo Receives Approval for Additional Indications of LIXIANA® (edoxaban) in Japan |
| 2014-09-03 | Daiichi Sankyo | Results Subgroup Analysis of ENGAGE AF-TIMI 48 Explores the Relationship Between Edoxaban Dose, Concentration, Anti-Factor Xa Activity and Outcomes daiichisankyo.com ↗
The analysis also compared rates of major bleeding and efficacy outcomes [stroke and systemic embolic events (SEE)] of edoxaban versus warfarin, stratified by dose reduction status. |
| 2014-03-24 | Daiichi Sankyo | Results Once-Daily Edoxaban Evaluated in Two Subgroup Analyses of East Asian Patients from the Largest Comparative Phase 3 Trials of a Novel Oral Anticoagulant daiichisankyo.com ↗
Subgroup analyses of East Asian populations from two phase 3 studies, ENGAGE AF-TIMI 48 and Hokusai-VTE, showed consistent results compared to the global study populations from these trials1,2,3,4 |
| 2014-01-09 | Daiichi Sankyo | Regulatory Daiichi Sankyo Submits SAVAYSA(TM) (edoxaban) Tablets New Drug Application to the U.S. FDA for Once-Daily Use for Stroke Risk Reduction in Atrial Fibrillation and for the Treatment and Prevention of Recurrence of Venous Thromboembolism daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the New Drug Application (NDA) for its investigational, oral, once-daily direct factor Xa-inhibitor SAVAYSATM (edoxaban) Tablets has been submitted to the U.S. Food and Drug Administration (FDA). |
| 2014-01-08 | Daiichi Sankyo | Regulatory Daiichi Sankyo Submits Edoxaban Marketing Authorization Application to the EMA for Once-Daily Use for Stroke Prevention in Atrial Fibrillation and for the Treatment and Prevention of Recurrence of Venous Thromboembolism daiichisankyo.com ↗
Daiichi Sankyo, Company Limited (hereafter, Daiichi Sankyo) today announced that the Marketing Authorization Application (MAA) for its investigational, oral, once-daily direct factor Xa-inhibitor edoxaban has been submitted to the European Medicines Agency (EMA). |
| 2013-12-19 | Daiichi Sankyo | Regulatory Daiichi Sankyo Submits Supplemental New Drug Application in Japan for LIXIANA® (Edoxaban Tosilate Hydrate) for New Indications daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has submitted a supplemental New Drug Application (NDA) for its oral, once-daily direct factor Xa-inhibitor LIXIANA® (Edoxaban Tosilate Hydrate) for review by the Japanese Ministry of Health, Labour and Welfare. |
| 2013-12-10 | Daiichi Sankyo | Results Phase 3 Data Show Daiichi Sankyo’s Once-Daily Edoxaban Lowered Incidence of VTE Recurrence and Clinically Relevant Bleeding Compared to Warfarin in a Large Subgroup of Patients with Cancer daiichisankyo.com ↗
Phase 3 Data Show Daiichi Sankyo’s Once-Daily Edoxaban Lowered Incidence of VTE Recurrence and Clinically Relevant Bleeding Compared to Warfarin in a Large Subgroup of Patients with Cancer |
| 2013-11-20 | Daiichi Sankyo | Results Daiichi Sankyo´s Once-Daily Edoxaban Meets Primary Efficacy Endpoint for Stroke Prevention and Superiority for the Principal Safety Endpoint Compared to Warfarin for Patients with Atrial Fibrillation in a Phase 3 Clinical Trial daiichisankyo.com ↗
This clinical trial found that the investigational, oral, once-daily direct factor Xa-inhibitor edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin for the prevention of stroke or systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). |
| 2013-09-01 | Daiichi Sankyo | Results Daiichi Sankyo’s Once-Daily Edoxaban Shows Comparable Efficacy and Superiority for the Principal Safety Endpoint Compared to Warfarin in a Phase 3 Study for the Treatment of Symptomatic VTE and Prevention of its Recurrence daiichisankyo.com ↗
Daiichi Sankyo’s Once-Daily Edoxaban Shows Comparable Efficacy and Superiority for the Principal Safety Endpoint Compared to Warfarin in a Phase 3 Study for the Treatment of Symptomatic VTE and Prevention of its Recurrence |
| 2011-12-13 | Daiichi Sankyo | Results Edoxaban Significantly Reduces Risk of Venous Thromboembolism by Half Compared to Enoxaparin in Japanese and Taiwanese Patients Following Knee or Hip Arthroplasty Surgery daiichisankyo.com ↗
Edoxaban Significantly Reduces Risk of Venous Thromboembolism by Half Compared to Enoxaparin in Japanese and Taiwanese Patients Following Knee or Hip Arthroplasty Surgery |
| 2011-04-22 | Daiichi Sankyo | Regulatory Daiichi Sankyo Receives First Market Approval in Japan for LIXIANA(R) (Edoxaban), a Direct Oral Factor Xa Inhibitor, for the Prevention of Venous Thromboembolism after Major Orthopedic Surgery daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), announced today that the company has received its first marketing approval for LIXIANA® (JAN: Edoxaban Tosilate Hydrate, INN:edoxaban) 15 mg and 30 mg tablets, by the Ministry of Health, Labor and Welfare in Japan. |
| 2010-12-08 | Daiichi Sankyo | Results EDOXABAN DEMONSTRATES SUPERIOR EFFICACY COMPARED WITH ENOXAPARIN SODIUM IN PREVENTING VTE AFTER TOTAL HIP REPLACEMENT daiichisankyo.com ↗
EDOXABAN DEMONSTRATES SUPERIOR EFFICACY COMPARED WITH ENOXAPARIN SODIUM IN PREVENTING VTE AFTER TOTAL HIP REPLACEMENT |
| 2010-07-12 | Daiichi Sankyo | Results EDOXABAN DEMONSTRATES SUPERIOR EFFICACY COMPARED WITH ENOXAPARIN SODIUM IN PREVENTING VTE AFTER TOTAL KNEE REPLACEMENT daiichisankyo.com ↗
Daiichi Sankyo Company, Limited announced that its investigational once-daily oral, direct factor Xa inhibitor, edoxaban, was shown to be superior toenoxaparin in preventing venous thromboembolic (VTE) events in patients following total knee replacement (TKR), a type of major orthopedic surgery. |
| 2010-04-06 | Daiichi Sankyo | Regulatory DAIICHI SANKYO SUBMITS FIRST NEW DRUG APPLICATION FOR ORAL FACTOR Xa INHIBITOR, EDOXABAN daiichisankyo.com ↗
Daiichi Sankyo Company, Limited announced today that it has submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan seeking approval of the anticoagulant, edoxaban, for the prevention of venous thromboembolism (VTE) after major orthopedic surgery. |
| 2009-12-11 | Daiichi Sankyo | Results Results of a Clinical Phase 3 Trial of an Oral Factor Xa Inhibitor, Edoxaban, in Prevention of Post-Operative Venous Thromboembolism daiichisankyo.com ↗
According to the results, non-inferiority to enoxaparin sodium was confirmed in edoxaban group in terms of the primary endpoint, which was the incidence of venous thromboembolism. |
| 2009-07-16 | Daiichi Sankyo | Results ANALYSIS OF EDOXABAN PHASE II DATA PROVIDES INSIGHT INTO REDUCED BLEEDING EVENTS SEEN IN ONCE-DAILY DOSING daiichisankyo.com ↗
The analysis finds that bleeding associated with edoxaban is most closely correlated with minimum concentration levels of the drug in the blood, and that these trough levels may best predict bleeding events, rather than total exposure or maximum concentration levels. |
| 2008-12-08 | Daiichi Sankyo | Results NEW PHASE II DATA SHOW SAFETY OF ONCE-DAILY ORAL FACTOR Xa INHIBITOR, DU-176b, COMPARABLE TO WARFARIN IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION daiichisankyo.com ↗
NEW PHASE II DATA SHOW SAFETY OF ONCE-DAILY ORAL FACTOR Xa INHIBITOR, DU-176b, COMPARABLE TO WARFARIN IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION |
| 2008-09-02 | Daiichi Sankyo | Results Daiichi Sankyo Announces Clinical Study Data for Oral Factor Xa Inhibitor DU-176b daiichisankyo.com ↗
Data presented today at the Annual Congress of the European Society of Cardiology showed that the investigational oral Factor Xa inhibitor DU-176b reduced the incidence of venous thromboembolism (VTE) compared with dalteparin among patients undergoing elective unilateral hip replacement surgery. |
All press releases naming this drug 48 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 118 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Edoxaban | “DOACs (eg Apixaban, dabigatran, edoxaban and rivaroxaban) are recommended by The National Institute for Health and Care Excellence (NICE) for those over 65 with AF and a...” NCT06322953 ↗105“NOAC includes dabigatran 150mg or 110mg twice daily, rivaroxaban 15mg daily with the reduced dose of 10mg daily, apixaban 5mg twice daily with the reduced dose of 2.5mg twice...” NCT01962545 ↗ “edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or...” NCT03968393 ↗ “Non-vitamin K antagonist oral anticoagulant therapy (e.g., apixaban, rivaroxaban, dabigatran, or edoxaban) administered according to approved labeling and guideline-recommended dosing.” NCT07497893 ↗ “Patients allocated to the DAT group receive either apixaban 5 mg twice daily, edoxaban 60 mg once daily, or rivaroxaban 15 mg once daily with clopidogrel 75 mg once daily.” NCT07583784 ↗ “Patients who are over 20 years old, have non-valvular atrial fibrillation, and are taking rivaroxaban, apixaban, or edoxaban (active ingredients)” NCT05801068 ↗ “NOAC of choice will be edoxaban. Patients will be treated with the recommended dose of 60mg once daily or the reduced dose of 30mg once daily.” NCT04436978 ↗ “Administration of approved DOACs (e.g., apixaban, rivaroxaban, edoxaban, or dabigatran) at standard stroke prevention dosages.” NCT07609654 ↗ “Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication.” PMID 41387009 ↗ Dec 2025 “For edoxaban: 15mg once daily for patients with standard 30mg dose, 30mg once daily for patients with standard 60mg dose” NCT07616414 ↗ “Apixaban or dabigatran or edoxaban or rivaroxaban at recommended dosing for stroke prevention in atrial fibrillation.” NCT02998905 ↗ |
| Known as | D006 | “Drug: Lixiana(D006)” NCT04673695 ↗1“Drug: Lixiana(D006)” NCT04867200 ↗ |
| Known as | DU-176 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1269025 ↗ |
| Known as | DU-176b | “edoxaban tosylate (DU-176b), film-coated for oral use, 90 mg once daily (QD) for 10 days (±2 days) followed by 60 mg QD for a total of approximately 90 days of edoxaban treatment” NCT01662908 ↗12“edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment” NCT00986154 ↗ “A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery” NCT00398216 ↗ “Drug: Edoxaban (DU-176b)” NCT00504556 ↗ |
| Known as | Edoxaban (Savaysa) | “Edoxaban (Savaysa)” NCT03465735 ↗ |
| Known as | Edoxaban tosilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1269025 ↗ |
| Known as | edoxaban tosylate | “edoxaban tosylate (DU-176b), film-coated for oral use, 90 mg once daily (QD) for 10 days (±2 days) followed by 60 mg QD for a total of approximately 90 days of edoxaban treatment” NCT01662908 ↗1“edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment” NCT00986154 ↗ |
| Known as | Lixiana | “Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)” NCT03148457 ↗ |
| Known as | Roteas | ChEMBL registry synonym — accepted as the source's own label CHEMBL1269025 ↗ |
| Known as | Savaysa | “Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)” NCT04684212 ↗ |
| Action | Inhibit | “Coagulation factor X inhibitor” CHEMBL1269025 ↗1“Factor Xa inhibitor” NCT00398216 ↗ |
| Modality | Small molecule | — CHEMBL1269025 ↗ |
| Route | Oral | “Oral DU-176b” NCT00107900 ↗ |
| Target | F10 | “Coagulation factor X inhibitor” CHEMBL1269025 ↗ |