Apixaban
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed atrial fibrillation 3 milestones | |||||
| Filed | US (FDA) | ELIQUIS | atrial fibrillation | 2012-09-26 | “Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for ELIQUIS ® (apixaban)” bms.com ↗ |
| Rejected (CRL) | US (FDA) | ELIQUIS | atrial fibrillation | 2012-06-25 | “issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ELIQUIS ® (apixaban) for the prevention of stroke and systemic embolism in patients with” bms.com ↗ |
| Filed | US (FDA) | ELIQUIS | atrial fibrillation | 2011-11-29 | “the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for ELIQUIS ® (apixaban)” bms.com ↗ |
| Filed puerperal pulmonary embolism 2 milestones | |||||
| Filed | US (FDA) | Eliquis | puerperal pulmonary embolism | 2013-12-19 | “the FDA has accepted for review a Supplemental New Drug Application for Eliquis for the treatment of deep vein thrombosis (DVT) and pulmonary embolism” bms.com ↗ “FDA) has accepted for review a Supplemental New Drug Application (sNDA) for ELIQUIS ® (apixaban) for the treatment of deep vein thrombosis” bms.com ↗ |
| Filed | EU (EMA) | Eliquis | puerperal pulmonary embolism | — | “in November 2013, the European Medicines Agency (EMA) accepted for review an application for Eliquis for the treatment of DVT and PE” bms.com ↗ “in November 2013 the European Medicines Agency accepted for review an application for ELIQUIS for the treatment of DVT and PE” bms.com ↗ |
| Filed venous thromboembolism 1 milestone | |||||
| Filed | US (FDA) | Eliquis | venous thromboembolism | 2013-07-11 | “Administration (FDA) has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis ® (apixaban), for the prophylaxis of deep vein thrombosis (DVT)” bms.com ↗ “the U.S. Food and Drug Administration (FDA) accepted for review the Supplemental New Drug Application for Eliquis” bms.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | ELIQUIS | — | 2014-03-13 – 2025-04-17 | fda.gov ↗ |
| Approved | US (FDA) | ELIQUIS | — | 2012-12-28 | fda.gov ↗ |
| Approved | EU (EMA) | Eliquis | — | 2011-05-18 | europa.eu ↗ |
Trials 171 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 05 trials | ||||||
| Phase 0 | NCT07011095 | Sep 2025 → Feb 2027 expected | atrial fibrillation | Population Health Research Institute | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06933056 | Sep 2025 → Sep 2026 overdue | — | University of Michigan | Recruiting | No outcome recorded |
| Phase 0 | NCT06886516 | Feb 2025 → Jul 2027 expected | pulmonary embolism, thrombocytopenia, venous thromboembolism | Rushad Patell | Recruiting | No outcome recorded |
| Phase 0 | NCT05995119 | Dec 2022 | — | TAHO Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 0 | NCT03935451 | Sep 2021 → Dec 2025 | Crohn disease, pulmonary embolism, ulcerative colitis, venous thromboembolism | McMaster University | Unknown | No outcome recorded |
| Phase 123 trials · 2 missed | ||||||
| Phase 1 | NCT07265466 | Nov 2025 → Mar 2026 overdue | — | Onconic Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05723510 | Mar → Jul 2023 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04874428 | May 2021 → Jun 2026 overdue | cirrhosis of liver | Insel Gruppe AG, University Hospital Bern | Recruiting | No outcome recorded |
| Phase 1 | NCT04278729 | Apr 2021 → Sep 2023 | membranous glomerulonephritis, nephrotic syndrome | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT04809818 | Mar → Aug 2021 | ischemic stroke | Lumosa Therapeutics Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04191928 | Mar → Jul 2020 | malignant pancreatic neoplasm, pulmonary embolism, venous thromboembolism | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 1 | NCT04006093 | Dec 2019 → Dec 2022 | chronic renal failure syndrome | University Hospital, Caen | Completed | No outcome recorded |
| Phase 1 | NCT03509883 | Apr → Jun 2018 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02599532 | Apr 2017 → Jun 2019 | nephrotic syndrome, proteinuria | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT02912234 | Sep → Oct 2016 | venous thromboembolism | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02080858 | May → Oct 2014 | acute coronary syndrome, atrial fibrillation | Medical University of Vienna | Completed | No outcome recorded |
| Phase 1 | NCT02101112 | Mar → May 2014 | thrombotic disease | Bristol-Myers Squibb | Completed | Mixed |
| Phase 1 | NCT02074358 | Feb → Apr 2014 | — | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 1 | NCT01707394 | Jan 2013 → Jun 2020 | thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02034591 | Oct → Nov 2011 | — | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 1 | NCT01437839 | Sep → Oct 2011 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01195727 | Jul 2011 → Jun 2012 | venous thromboembolism | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 1 | NCT02034578 | Jul → Aug 2011 | — | Bristol-Myers Squibb | Completed | Mixed |
| Phase 1 | NCT01340586 | Jun → Sep 2011 | end stage renal failure | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02034565 | Feb → Mar 2010 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00914641 | Jun → Aug 2009 | thrombotic disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02262533 | Jun 2007 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02262520 | Jan → Mar 2006 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04850378 | Mar 2021 → May 2024 | nephrotic syndrome, thrombotic disease | University of Aarhus | Completed | No outcome recorded |
| Phase 1/2 | NCT04504318 | Aug 2020 → Jun 2024 | venous thromboembolism | Stanford University | Completed | No outcome recorded |
| Phase 231 trials · 1 met primary · 3 missed | ||||||
| Phase 2 | NCT07246005 | Dec 2026 → Dec 2027 expected | thrombotic disease | Queen Mary University of London | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06729034 | Feb 2025 → Dec 2030 expected | vascular malformation | Oslo University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06689436 | Nov 2024 → Jan 2025 | — | TAHO Pharmaceuticals Ltd. | Completed | Met primary |
| Phase 2 | NCT05869591 | Jan 2024 → Jun 2026 overdue | cirrhosis of liver | Centre Hospitalier Universitaire Vaudois | Recruiting | No outcome recorded |
| Phase 2 | NCT05618808 | May 2023 → May 2024 | venous thromboembolism | Regeneron Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT05683808 | Jan 2023 → Dec 2026 expected | astrocytoma (excluding glioblastoma), glioblastoma, venous thromboembolism | University of Vermont Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05006287 | Oct 2022 → May 2024 | atrial fibrillation | St. Paul's Hospital, Canada | Unknown | No outcome recorded |
| Phase 2 | NCT05088928 | Mar → May 2022 | COVID-19 | Scotmann Pharmaceuticals | Unknown | No outcome recorded |
| Phase 2 | NCT05089227 | Feb 2022 → Aug 2028 expected | autoimmune hemolytic anemia, venous thromboembolism | Centre Hospitalier Universitaire Dijon | Recruiting | No outcome recorded |
| Phase 2 | NCT04865978 | Dec 2021 → Oct 2023 | heart failure | Palak Shah | Completed | Missed primary |
| Phase 2 | NCT04952792 | May 2021 → Dec 2022 | atrial fibrillation | Hospital Universitari de Bellvitge | Completed | No outcome recorded |
| Phase 2 | NCT04696120 | Mar 2021 → Aug 2022 | cardiac rhythm disease, cerebrovascular disorder, heart failure | Korea University Guro Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04243122 | Feb 2021 → Oct 2023 | acquired polycythemia vera, essential thrombocythemia, primary myelofibrosis, venous thromboembolism | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT04106700 | Apr 2019 → Aug 2020 | venous thromboembolism | La Fe Health Research Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03594045 | Dec 2018 → Oct 2019 | heparin-induced thrombocytopenia | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03251482 | Nov 2017 → Nov 2018 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT03200613 | Sep 2017 → Jul 2019 | spinal cord injury, venous thromboembolism | McMaster University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03310021 | Aug 2017 → Aug 2019 | hemorrhagic disease | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03139487 | Aug 2017 → Sep 2021 | ampulla of vater cancer, esophageal cancer, gastric cancer, gastroesophageal cancer +3 | Asan Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT04041843 | Jun 2017 → May 2021 | venous thromboembolism | New York Medical College | 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 | NCT02981472 | Jan 2017 → Oct 2021 | thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT03456648 | Sep 2016 → Aug 2018 | end stage renal failure, poisoning | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 2 | NCT02749617 | Aug 2016 → Jan 2018 | — | University of British Columbia | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02809469 | Aug 2016 → Aug 2018 | atrial fibrillation | Hamilton Health Sciences Corporation | Unknown | No outcome recorded |
| Phase 2 | NCT02366871 | Apr 2015 → Jun 2019 | female reproductive organ cancer, venous thromboembolism | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT02565693 | Sep 2014 → Jan 2021 | atrial fibrillation, intracerebral hemorrhage | UMC Utrecht | Completed | Missed primary |
| Phase 2 | NCT00852397 | Apr 2009 → Dec 2010 | acute coronary syndrome | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00787150 | Jun 2008 → Sep 2009 | atrial fibrillation | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00313300 | May 2006 → May 2008 | acute coronary syndrome | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT00252005 | Nov 2005 → Feb 2007 | venous thromboembolism | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT01924325 | Jan 2014 → Dec 2015 | transient ischemic attack | Xijing Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT00097357 | Oct 2004 → Dec 2005 | pulmonary embolism, venous thromboembolism | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 345 trials · 8 met primary · 12 missed | ||||||
| Phase 3 | NCT07471139 | Aug 2026 → Aug 2029 expected | heart failure, hemorrhagic disease, stroke disorder, thrombotic disease | Columbia University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07709780 | Jun 2026 → Jul 2028 expected | thrombotic disease | University of Arizona | Recruiting | No outcome recorded |
| Phase 3 | NCT07160686 | Apr 2026 → Oct 2029 expected | venous thromboembolism | University of Birmingham | Recruiting | No outcome recorded |
| Phase 3 | NCT07005024 | Oct 2025 → Aug 2035 expected | cancer, venous thromboembolism | University of Vermont | Recruiting | No outcome recorded |
| Phase 3 | NCT05687448 | Sep 2025 overdue | aortic valve disorder | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06742567 | Dec 2024 → Nov 2025 overdue | acute myocardial infarction, thrombotic disease | National Institute of Cardiovascular Diseases, Pakistan | Recruiting | No outcome recorded |
| Phase 3 | NCT06045858 | Oct 2024 → Oct 2027 expected | atrial fibrillation | University Hospital, Caen | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05387954 | Jul 2023 → Jul 2031 expected | ischemic stroke, patent foramen ovale | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT05825573 | May 2023 → Feb 2025 overdue | ST-elevation myocardial infarction, heart failure, thrombotic disease | Nîmes University Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04981327 | Sep 2022 → Aug 2026 overdue | venous thromboembolism | University Hospital, Geneva | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05198960 | Jul 2022 → Jul 2027 expected | acquired polycythemia vera, essential thrombocythemia, primary myelofibrosis | University Hospital, Brest | Recruiting | No outcome recorded |
| Phase 3 | NCT05035277 | Dec 2021 → Jun 2026 | aortic valve stenosis | Oslo University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT04788355 | Jul → Nov 2020 | pregnancy disorder | Universidade do Vale do Sapucai | Completed | No outcome recorded |
| Phase 3 | NCT04142658 | May 2020 → Dec 2022 | aortic valve stenosis | Artivion Inc. | Terminated | Missed primary |
| Phase 3 | NCT04229264 | Jan 2020 → Feb 2022 | limb ischemia | Science Valley Research Institute | Unknown | 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 | NCT03996772 | Jun 2019 → May 2024 | atrial fibrillation, intracerebral hemorrhage | Imperial College London | Completed | Mixed |
| Phase 3 | NCT03243175 | Jan 2019 → Jan 2029 expected | atrial fibrillation, intracerebral hemorrhage | University Hospital, Lille | Recruiting | 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 | NCT05208398 | Feb 2018 → Sep 2021 | thrombotic disease | Saud Al Babtain Cardiac Center | Completed | No outcome recorded |
| Phase 3 | NCT03192215 | Jan 2018 → Mar 2023 | stroke disorder | Columbia University | Terminated | Missed primary |
| Phase 3 | NCT03285438 | Nov 2017 → Nov 2023 | venous thromboembolism | University Hospital, Brest | Completed | Missed primary |
| Phase 3 | NCT03080883 | Jul 2017 → Jun 2022 | cerebral sinovenous thrombosis, hematopoietic and lymphoid cell neoplasm, metastatic malignant neoplasm, pulmonary embolism +1 | Academic and Community Cancer Research United | Completed | Missed primary |
| Phase 3 | NCT03181386 | May 2017 → Nov 2020 | atrial fibrillation, hemorrhagic disease, periodontal disorder | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT03045406 | Apr 2017 → Jun 2019 | venous thromboembolism | Fadoi Foundation, Italy | Completed | Met primary |
| Phase 3 | NCT02982590 | Nov 2016 → Nov 2018 | thrombotic disease | Universiti Sains Malaysia | Completed | No outcome recorded |
| Phase 3 | NCT02664155 | Oct 2016 → Nov 2021 | impaired renal function disease | University Hospital of Saint-Etienne | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02664649 | Aug 2016 → Oct 2020 | aortic valve stenosis | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 3 | NCT02427126 | Dec 2015 → Aug 2020 | — | University Hospital Tuebingen | Completed | Missed primary |
| Phase 3 | NCT02585713 | Nov 2015 → Apr 2018 | cerebral sinovenous thrombosis, hepatic vein thrombosis, isolated mesenteric vein thrombosis, isolated splenic vein thrombosis +4 | Academic and Community Cancer Research United | Completed | Missed primary |
| Phase 3 | NCT02369653 | Oct 2015 → Jul 2021 | acute lymphoblastic leukemia | Bristol-Myers Squibb | Completed | Mixed |
| Phase 3 | NCT02283294 | Apr 2015 → Jun 2019 | atrial fibrillation, transient ischemic attack | University of South Florida | Completed | Missed primary |
| Phase 3 | NCT02066454 | Jun 2014 → Jul 2016 | plasma cell myeloma, venous thromboembolism | University Hospital, Grenoble | Completed | No outcome recorded |
| Phase 3 | NCT01780987 | Jan 2013 → Sep 2014 | pulmonary embolism, venous thromboembolism | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01675076 | Jan 2013 → Oct 2017 | — | Ottawa Heart Institute Research Corporation | Completed | Missed primary |
| Phase 3 | NCT00643201 | Jul 2008 → Mar 2013 | venous thromboembolism | Bristol-Myers Squibb | Completed | Met primary |
| Phase 3 | NCT00633893 | May 2008 → Aug 2012 | venous thromboembolism | Bristol-Myers Squibb | Completed | Met primary |
| Phase 3 | NCT00562289 | Dec 2007 → Dec 2016 | atrial septal aneurysm, ischemic stroke, migraine disorder, patent foramen ovale | Assistance Publique - Hôpitaux de Paris | Completed | Met primary |
| Phase 3 | NCT00496769 | Aug 2007 → Nov 2010 | atrial fibrillation | Bristol-Myers Squibb | Completed | Met primary |
| Phase 3 | NCT00452530 | Jun 2007 → Jan 2009 | pulmonary embolism, venous thromboembolism | Bristol-Myers Squibb | Completed | Met primary |
| Phase 3 | NCT00457002 | Jun 2007 → May 2011 | pulmonary embolism, venous thromboembolism | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 3 | NCT00423319 | Mar 2007 → Sep 2009 | pulmonary embolism, venous thromboembolism | Bristol-Myers Squibb | Completed | Met primary |
| Phase 3 | NCT00412984 | Dec 2006 → May 2011 | atrial fibrillation, atrial flutter | Bristol-Myers Squibb | Completed | Met primary |
| Phase 3 | NCT00371683 | Nov 2006 → May 2008 | pulmonary embolism, venous thromboembolism | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 445 trials · 4 met primary · 2 missed | ||||||
| Phase 4 | NCT07853612 | Sep 2026 → Oct 2027 expected | coronary artery disorder | The University of The West Indies | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07713875 | Aug 2026 → Nov 2027 expected | metastatic malignant neoplasm in the spinal cord, pulmonary embolism, venous thromboembolism | James Bayley | Not yet recruiting | No outcome recorded |
| 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 | NCT07521332 | Apr 2026 → Apr 2027 expected | cirrhosis of liver, esophageal varices, hepatic encephalopathy, portal hypertension +1 | Asian Institute Of Medical Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT07404345 | Mar 2026 → Mar 2028 expected | end stage renal failure | Hospital Civil de Guadalajara | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07237308 | Dec 2025 → Jul 2029 expected | atrial fibrillation, intracranial arteriosclerosis, ischemic disease, stroke disorder | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07189897 | Oct 2025 → Sep 2027 expected | head and neck cancer, venous thromboembolism | Kiranya Arnold | Recruiting | No outcome recorded |
| Phase 4 | NCT06486792 | Jun 2025 → Dec 2028 expected | atrial fibrillation, cerebral infarction | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 4 | NCT06515730 | Apr 2025 → Apr 2028 expected | acute myocardial infarction, thrombotic disease | Karolinska Institutet | Recruiting | No outcome recorded |
| Phase 4 | NCT06603870 | Dec 2024 → Oct 2029 expected | cancer, prosthesis-related infectious disease, venous thromboembolism | Ottawa Hospital Research Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT06523959 | Jun 2024 → Sep 2028 expected | hemorrhagic disease, venous thromboembolism | Clinical Urology and Epidemiology Working Group | Recruiting | No outcome recorded |
| Phase 4 | NCT06401616 | May 2024 → Mar 2028 expected | atrial fibrillation | Odense University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05735639 | Jan 2024 → Jun 2027 expected | varicose disease, venous thromboembolism | Imperial College London | Recruiting | No outcome recorded |
| Phase 4 | NCT07132515 | Aug 2023 → Aug 2025 overdue | cirrhosis of liver, hepatocellular carcinoma, portal vein thrombosis | Mansoura University | Recruiting | No outcome recorded |
| Phase 4 | NCT05973188 | May 2023 → Jun 2024 | thrombotic disease | Peshawar Institute of Cardiology | Unknown | 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 | NCT04168203 | Mar 2021 → Nov 2023 | pulmonary embolism, venous thromboembolism | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04479579 | Feb → Oct 2021 | cancer, venous thromboembolism | McMaster University | Completed | No outcome recorded |
| Phase 4 | NCT04344717 | Dec 2020 → Dec 2024 | short bowel syndrome | Universitaire Ziekenhuizen KU Leuven | Unknown | No outcome recorded |
| Phase 4 | NCT04645550 | Nov 2020 → Dec 2023 | cirrhosis of liver, portal hypertension, splenic disorder, venous thromboembolism | Northern Jiangsu People's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04512079 | Sep 2020 → Dec 2022 | COVID-19 | Valentin Fuster | Completed | Missed primary |
| Phase 4 | NCT04437654 | Jul 2020 → Aug 2025 | — | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT04432220 | Jul 2020 → Jul 2026 overdue | — | Yonsei University | Recruiting | Met primary |
| Phase 4 | NCT04489849 | Mar 2020 → Mar 2022 | — | National Taiwan University Hospital Hsin-Chu Branch | Unknown | No outcome recorded |
| Phase 4 | NCT04128254 | Jan → Dec 2020 | venous thromboembolism | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT04023760 | Jun 2019 → Mar 2020 | — | University of Saskatchewan | 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 | NCT05632445 | May → Jun 2019 | — | DR. XAVIER FREIXA | Completed | Met primary |
| Phase 4 | NCT03678506 | Aug 2018 → Sep 2021 | venous thromboembolism | Arianna Anticoagulazione Foundation | Terminated | No outcome recorded |
| Phase 4 | NCT07699796 | Mar 2018 → Nov 2020 | chronic venous insufficiency, varicose disease, venous thromboembolism | Heart, Artery, and Vein Center of Fresno | Completed | No outcome recorded |
| Phase 4 | NCT02958969 | Feb 2018 → Jun 2019 | plasma cell myeloma, venous thromboembolism | Gregory Piazza | Completed | No outcome recorded |
| Phase 4 | NCT02945280 | Feb 2017 → Nov 2021 | thrombotic disease, venous thromboembolism | Intermountain Health Care, Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT02942407 | Dec 2016 → Jul 2019 | atrial fibrillation, end stage renal failure | Christopher Granger, MD | Completed | No outcome recorded |
| Phase 4 | NCT02672709 | Apr → Aug 2016 | end stage renal failure | Jewish General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02581176 | Apr 2016 → May 2018 | neoplasm, venous thromboembolism | University Hospital, Akershus | Completed | No outcome recorded |
| Phase 4 | NCT02464969 | Nov 2015 → Apr 2024 | venous thromboembolism | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT02426944 | Oct 2015 → Jul 2019 | atrial fibrillation | Charles University, Czech Republic | Completed | Met primary |
| Phase 4 | NCT01938248 | May 2015 → Oct 2023 | atrial fibrillation, stroke disorder | Population Health Research Institute | Completed | Mixed |
| Phase 4 | NCT01884337 | Mar 2015 → Jun 2018 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT02295475 | Dec 2014 → Apr 2020 | antiphospholipid syndrome, thrombotic disease | Scott C. Woller, MD | Completed | No outcome recorded |
| Phase 4 | NCT02227550 | Dec 2014 → Apr 2017 | atrial fibrillation | Atrial Fibrillation Network | Completed | No outcome recorded |
| Phase 4 | NCT02100228 | Jul 2014 → Feb 2017 | atrial fibrillation | Pfizer | Completed | Mixed |
| Phase 4 | NCT01884350 | Oct 2013 → Jan 2016 | atrial fibrillation | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 4 | NCT01706146 | Oct 2012 → Feb 2015 | atrial fibrillation | Northwestern University | Completed | No outcome recorded |
| Phase not applicable18 trials · 1 met primary | ||||||
| — | NCT07869615 | Sep 2026 → Apr 2027 expected | — | Military Hospital of Tunis | Recruiting | No outcome recorded |
| — | NCT07461532 | Apr 2026 → Sep 2027 expected | cirrhosis of liver, portal hypertension, portal vein thrombosis | Northern Jiangsu People's Hospital | Recruiting | No outcome recorded |
| — | NCT07461545 | Apr 2026 → Sep 2027 expected | cirrhosis of liver, portal hypertension, portal vein thrombosis | Northern Jiangsu People's Hospital | Recruiting | No outcome recorded |
| — | NCT07559942 | Jan → Jun 2026 overdue | end stage renal failure, vascular occlusion disorder | Combined military hospital lahore | Recruiting | No outcome recorded |
| — | NCT06474182 | Sep 2025 → Sep 2027 expected | plasma cell myeloma | University Hospital of Saint-Etienne | 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 |
| — | NCT07270263 | Nov 2024 → Apr 2026 overdue | leukemia, lymphoma, pulmonary embolism, venous thromboembolism | Medical University of Gdansk | Recruiting | No outcome recorded |
| — | NCT06057467 | Sep 2023 → Oct 2025 | atrial fibrillation, ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| — | NCT05484557 | Sep 2023 → Aug 2027 expected | spinal cord injury | Loewenstein Hospital | Recruiting | No outcome recorded |
| — | NCT05419583 | Nov 2022 → Jun 2024 | myocardial infarction | University of Edinburgh | Completed | No outcome recorded |
| — | NCT05304455 | Apr 2022 → May 2023 | cirrhosis of liver, portal hypertension, portal vein thrombosis | Northern Jiangsu People's Hospital | Completed | No outcome recorded |
| — | NCT04974684 | Apr 2022 → Mar 2024 | thrombotic disease | Institute for Clinical and Experimental Medicine | 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 |
| — | NCT03148457 | Nov 2017 → Dec 2022 | ischemic stroke | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| — | NCT03136510 | Sep 2016 → Dec 2018 | atrial fibrillation, blood coagulation disease | Hopital Lariboisière | Terminated | No outcome recorded |
| — | NCT02504177 | Jun 2015 → Jun 2019 | atrial fibrillation | Yonsei University | Unknown | No outcome recorded |
| Comparator or background therapy96 trials | ||||||
| Phase 0 | NCT06615596 Comparator | Aug 2025 → Jan 2029 expected | atrial fibrillation | China National Center for Cardiovascular Diseases | Recruiting | No outcome recorded |
| Phase 1 | NCT07312851 Background | Jan → Jun 2026 | — | AstraZeneca | Completed | No outcome recorded |
| 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 | NCT03083782 Comparator | Apr → Jun 2017 | venous thromboembolism | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 1 | NCT03083704 Background | Feb → Sep 2017 | hemorrhagic disease | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02946944 Comparator | Oct 2016 → Oct 2020 | pulmonary embolism | Meshalkin Research Institute of Pathology of Circulation | Unknown | No outcome recorded |
| Phase 1 | NCT02270918 Comparator | Nov → Dec 2014 | thrombotic disease | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 2 | NCT07175428 Comparator | Oct 2025 → Feb 2027 expected | atrial fibrillation | Regeneron Pharmaceuticals | Recruiting | 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 | NCT04218266 Comparator | Jan 2020 → Oct 2021 | atrial fibrillation | Bayer | Completed | Met primary |
| Phase 2 | NCT03987711 Comparator | Dec 2019 → Dec 2022 | atrial fibrillation, end stage renal failure | Unity Health Toronto | Completed | Mixed |
| Phase 2 | NCT03398434 Comparator | Oct 2018 → Nov 2019 | atrial fibrillation | Novartis Pharmaceuticals | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03276143 Comparator | Sep 2017 → Aug 2018 | osteoarthritis, knee | Bayer | Completed | Mixed |
| Phase 2 | NCT03288454 Background | Aug 2017 → Aug 2019 | — | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02450682 Comparator | Feb 2016 → Jan 2017 | atrial fibrillation | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 2 | NCT02378623 Comparator | May 2015 → Jan 2020 | patent foramen ovale | Mayo Clinic | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02048865 Comparator | Mar 2014 → Oct 2018 | cancer, venous thromboembolism | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT01758432 Background | Dec 2012 → Sep 2015 | — | Portola Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT00320255 Comparator | Jun 2006 → Jan 2009 | cancer, pulmonary embolism, thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2/3 | NCT02889562 Comparator | Sep 2016 → May 2019 | atrial fibrillation, stroke disorder, venous thromboembolism | Sanford Health | Completed | No outcome recorded |
| Phase 2/3 | NCT02829957 Comparator | Sep 2016 → Feb 2020 | menstrual disorder, venous thromboembolism | Indiana University | Completed | No outcome recorded |
| Phase 3 | NCT07840365 Comparator | Sep 2026 → Dec 2028 expected | atrial fibrillation | Texas Cardiac Arrhythmia Research Foundation | Recruiting | No outcome recorded |
| Phase 3 | NCT07493304 Comparator | Aug 2026 → Jul 2031 expected | venous thromboembolism | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT07626411 Comparator | Aug 2026 → Sep 2029 expected | atrial fibrillation | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT07434661 Comparator | Feb 2026 → Jan 2028 expected | aortic valve disorder, atrial fibrillation, cardiac valvular defect | Meshalkin Research Institute of Pathology of Circulation | Not yet 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 | NCT07015905 Comparator | Jun 2025 → Feb 2027 expected | venous thromboembolism | Regeneron Pharmaceuticals | 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 | NCT06370273 Comparator | Nov 2024 → Aug 2028 expected | thrombotic disease | Queen Mary University of London | Recruiting | No outcome recorded |
| Phase 3 | NCT05894954 Background | Jul 2023 → Oct 2025 | cognitive impairment with or without cerebellar ataxia, dementia | Alzheimer's Prevention and Reversal Project, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05757869 Comparator | Apr 2023 → Dec 2026 expected | atrial fibrillation | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05679024 Comparator | Feb 2023 → Dec 2027 expected | atrial fibrillation, chronic kidney disease, intracerebral hemorrhage, venous thromboembolism | Region Stockholm | Recruiting | No outcome recorded |
| Phase 3 | NCT05643573 Comparator | Dec 2022 → Jan 2024 | atrial fibrillation | Bayer | Terminated | No outcome recorded |
| Phase 3 | NCT05171049 Comparator | May 2022 → Feb 2026 | pulmonary embolism, venous thromboembolism | Anthos Therapeutics, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT06531122 Comparator | Aug 2021 → Sep 2024 overdue | cerebral sinovenous thrombosis | Kafrelsheikh University | Recruiting | No outcome recorded |
| Phase 3 | NCT06551415 Comparator | Aug 2021 → Sep 2024 overdue | cerebral sinovenous thrombosis | Kafrelsheikh University | Recruiting | No outcome recorded |
| Phase 3 | NCT04284839 Comparator | Jul 2021 → Jun 2027 expected | — | Population Health Research Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT04891861 Comparator | Jul 2021 → Jul 2023 | hyperheparinemia | University of Texas at Austin | Unknown | No outcome recorded |
| Phase 3 | NCT04801940 Comparator | May 2021 → Jan 2024 | COVID-19 | Cambridge University Hospitals NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 3 | NCT04650087 Comparator | Feb 2021 → Jul 2022 | COVID-19 | Thomas L. Ortel | Completed | No outcome recorded |
| Phase 3 | NCT04498273 Comparator | Sep 2020 → Aug 2021 | COVID-19 | Frank C Sciurba | Terminated | No outcome recorded |
| Phase 3 | NCT03907046 Comparator | Jan 2020 → Apr 2027 expected | atrial fibrillation, intracerebral hemorrhage | Yale University | Recruiting | No outcome recorded |
| Phase 3 | NCT04462003 Comparator | Jul 2019 → Jul 2020 | cancer, venous thromboembolism | Beni-Suef University | Unknown | No outcome recorded |
| Phase 3 | NCT04007289 Comparator | Jun 2019 → Jul 2026 overdue | portal hypertension, noncirrhotic | Assistance Publique - Hôpitaux de Paris | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03839355 Comparator | Dec 2018 → Dec 2020 | atrial fibrillation | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03692065 Comparator | Oct 2018 → Sep 2024 | blood coagulation disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT03232398 Comparator | Jan 2018 → Mar 2021 | acute myocardial infarction, thrombotic disease | Hadassah Medical Organization | Completed | No outcome recorded |
| Phase 3 | NCT02933697 Comparator | Jun 2017 → Jul 2022 | atrial fibrillation, end stage renal failure | Atrial Fibrillation Network | Completed | No outcome recorded |
| Phase 3 | NCT02179177 Comparator | Jan 2015 → Sep 2017 | sickle cell disease | Nirmish Shah | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01924065 Comparator | Aug 2013 → Aug 2017 | atrial fibrillation, stroke disorder | Suleyman Demirel University | Completed | No outcome recorded |
| Phase 3 | NCT00831441 Comparator | Mar 2009 → Mar 2011 | acute coronary syndrome | Bristol-Myers Squibb | Terminated | 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 | NCT06953726 Comparator | Jun 2026 → Oct 2032 expected | atrial fibrillation | VA Office of Research and Development | 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 | NCT06212674 Comparator | Oct 2025 → Oct 2027 expected | atrial fibrillation, ischemic stroke | Medical University of Silesia | Recruiting | No outcome recorded |
| Phase 4 | NCT06862726 Comparator | Dec 2024 → Dec 2025 overdue | atrial fibrillation | Les Laboratoires des Médicaments Stériles | Enrolling by invitation | 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 | NCT04642430 Comparator | Jul 2021 → Dec 2027 expected | atrial fibrillation | Ottawa Hospital Research Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT04746339 Comparator | Mar 2021 → May 2022 | COVID-19, thrombotic disease | Brazilian Clinical Research Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04666454 Comparator | Dec 2020 → Dec 2028 expected | Tako-tsubo cardiomyopathy | Vastra Gotaland Region | Recruiting | No outcome recorded |
| Phase 4 | NCT04250116 Background | Apr 2020 → May 2026 | atrial fibrillation | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT03988842 Background | Jul 2019 → Apr 2020 | acute cor pulmonale, pulmonary embolism, pulmonary embolism and infarction | Victor Tapson, MD | Terminated | No outcome recorded |
| Phase 4 | NCT03590743 Comparator | Feb → Jun 2019 | venous thromboembolism | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| 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 | NCT03196349 Comparator | Aug 2018 → May 2019 | venous thromboembolism | Duke University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03463317 Comparator | Feb 2018 → Nov 2024 | atrial fibrillation | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 4 | NCT03266783 Comparator | Dec 2017 → Apr 2025 | venous thromboembolism | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02406885 Comparator | Jul 2017 → Feb 2020 | obesity disorder | Johns Hopkins University | 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 | NCT02559856 Comparator | May 2016 → Nov 2017 | venous thromboembolism | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02701062 Background | Feb 2016 → Apr 2019 | atrial fibrillation | AtriCure, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02666157 Comparator | Jan 2016 → Dec 2018 | atrial fibrillation | National Cheng-Kung University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02608099 Comparator | Nov 2015 → Apr 2017 | atrial fibrillation | Baim Institute for Clinical Research | Completed | No outcome recorded |
| Phase 4 | NCT02935855 Comparator | Sep 2015 → Apr 2019 | diabetes mellitus | University of Pavia | Completed | No outcome recorded |
| Phase 4 | NCT02415400 Comparator | Jun 2015 → Nov 2018 | acute coronary syndrome | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT02090075 Comparator | Sep 2014 → Dec 2016 | atrial fibrillation | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | 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 |
| — | NCT06866665 Comparator | Mar 2025 → Dec 2030 expected | atrial fibrillation, coronary artery disorder | Yonsei University | Not yet recruiting | No outcome recorded |
| — | NCT06699342 Comparator | Jan 2025 → Dec 2027 expected | atrial fibrillation | Seoul National University Hospital | Recruiting | No outcome recorded |
| — | NCT06055920 Comparator | Nov 2023 → Jul 2026 overdue | pulmonary embolism | Inari Medical | Active not recruiting | No outcome recorded |
| — | NCT05705076 Comparator | Jan 2023 → Mar 2024 | hyperheparinemia | Mansoura University | Unknown | No outcome recorded |
| — | NCT05701917 Comparator | Jan 2023 → Jan 2028 expected | post-thrombotic syndrome, venous thromboembolism | Inari Medical | Recruiting | No outcome recorded |
| — | NCT05472766 Comparator | Nov 2022 → Mar 2024 | atrial fibrillation | Sunnybrook Health Sciences Centre | Terminated | No outcome recorded |
| — | NCT05622500 Background | Sep 2022 → Apr 2025 | chronic venous insufficiency, post-thrombotic syndrome | Imperial College London | Terminated | No outcome recorded Stop: Enrollment |
| — | 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 |
| — | NCT02633774 Comparator | Nov 2015 → Nov 2020 | persistent atrial fibrillation | Yonsei University | Unknown | No outcome recorded |
| — | NCT01999179 Background | Jun 2014 → Apr 2019 | neoplasm, venous thromboembolism | Medical College of Wisconsin | Completed | No outcome recorded |
| — | NCT05187286 Background | — | — | Bristol-Myers Squibb | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 75
| Date | Issuer | Release |
|---|---|---|
| 2026-09-28 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Novel Apixaban Oral Suspension lupin.com ↗
Global pharma major, Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its New Drug Application for Apixaban Oral Suspension 1.25mg/mL via the 505(b)(2) pathway. |
| 2026-09-07 | TAHO Pharmaceuticals Ltd. | Regulatory 泰合生技抗血栓口溶膜(BEQIA)美國新藥查驗登記(NDA)申請 審查完成目標日期為2027年4月22日 (股票代碼6467) tahopharma.com ↗
泰合生技(股票代碼:6467)今宣布,旗下抗血栓口溶膜 BEQIA(TAH3311)美國新藥查驗登記(New Drug Application, NDA)申請,獲美國食品藥物管理局(FDA)來函確認申請資料完整,已正式進入標準審查(Standard Review)程序。 |
| 2025-11-27 | TAHO Pharmaceuticals Ltd. | Regulatory 泰合生技TAH3311抗血栓口溶膜 (商品名BEQIA)上市許可申請獲歐洲藥品管理局(EMA)正式受理 (股票代碼6467) tahopharma.com ↗
泰合生技藥品公司今日宣布,其於2025年10月30日向歐洲藥品管理局(European Medicines Agency, EMA)提交的TAH3311抗凝血口溶膜(商品名BEQIA)上市許可申請(Marketing Authorization Application, MAA)已完成文件確認並正式進入審查程序。 |
| 2025-10-31 | TAHO Pharmaceuticals Ltd. | Regulatory 泰合生技向歐洲藥品管理局(EMA)提交TAH3311 抗血栓口溶膜上市許可申請 (股票代碼6467) tahopharma.com ↗
泰合生技藥品公司今日宣布,已於中歐時間10月30日正式向歐洲藥品管理局(European Medicines Agency, EMA)提交TAH3311的歐洲上市許可申請(Marketing Authorization Application, MAA)。 |
| 2025-10-01 | TAHO Pharmaceuticals Ltd. | Regulatory 泰合生技宣布全球首創TAH3311抗血栓口溶膜新藥完成遞送美國新藥查驗登記(New Drug Application, NDA)申請 (股票代碼6467) tahopharma.com ↗
泰合生技藥品公司宣布已於美國時間9月30日成功向美國FDA提交全球首創的TAH3311抗血栓口溶膜新藥查驗登記申請(New Drug Application, NDA),此項申請為泰合生技在開發505(b)(2)新劑型新藥並推動至商品化的重要里程碑,未來泰合生技將依計畫時程繼續推進歐洲及其他地區的藥證申請。 |
| 2025-05-08 | TAHO Pharmaceuticals Ltd. | Results 泰合生技TAH3311口溶膜新藥樞紐試驗成功,將準備送美國與歐洲藥證申請 (股票代碼6467) tahopharma.com ↗
試驗結果顯示,TAH3311與美國及歐洲原廠Apixaban錠劑(商品名Eliquis ® ),在空腹條件下之藥物動力學指標C max (最高血中濃度)與AUC(藥物動力學曲線下面積)的幾何平均數比值以及其90%信賴區間(Confidence interval, CI)均符合生體相等性(Bioequivalence, BE)之法定標準80-125%範圍內,為未來新藥查驗登記奠定基礎。 |
| 2025-02-17 | TAHO Pharmaceuticals Ltd. | Results 泰合生技TAH3311抗血栓口溶膜美國Pivotal study(樞紐試驗)初步試驗數據分析 結果達標 (股票代碼6467) tahopharma.com ↗
試驗結果顯示,TAH3311與美國及歐洲原廠Apixaban錠劑(商品名Eliquis®)比較,於空腹條件下之關鍵藥物動力學指標Cmax (最高血中濃度)與AUC(藥物動力學曲線下面積)之幾何平均數比值以及其90%信賴區間均達到生體相等性(Bioequivalence,BE)之法定標準80-125%範圍內,符合美國食品藥物管理局(FDA)與歐洲藥品管理局(EMA)的法規要求,向藥證申請邁出關鍵的一步。 |
| 2024-03-25 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Present Data at the American College of Cardiology Annual Scientific Session 2024 Reinforcing Extensive Body of Evidence in Clinical and Real-World Settings Across Cardiovascular Portfolio bms.com ↗
those who received ELIQUIS had a statistically significant lower risk of stroke/systemic embolism (S/SE) and major bleeding (MB) than those patients who received rivaroxaban |
| 2023-08-25 | Bristol-Myers Squibb | Results Retrospective Observational Study Assessing Real-World Clinical Impact of Switching or Continuing Eliquis® or Rivaroxaban Presented at the European Society of Cardiology (ESC) Congress 2023 bms.com ↗
Switching from Eliquis (apixaban) to rivaroxaban in Non-Valvular Atrial Fibrillation (NVAF) patients was associated with a higher risk of stroke/systemic embolism (S/SE) and major bleeding (MB) than those who continued Eliquis |
| 2023-02-28 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Apixaban Tablets, 2.5 mg and 5 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Apixaban Tablets, 2.5 mg and 5 mg (USRLD: Eliquis® Tablets). |
| 2022-12-09 | Janssen Research & Development, LLC | Results Real-World Study Confirms Benefit of XARELTO® (rivaroxaban) for Secondary Prevention of Venous Thromboembolism in Cancer Patients jnj.com ↗
Data from the Observational Study in Cancer-Associated Thrombosis for Rivaroxaban (OSCAR) found XARELTO®showed non-inferiority for the composite outcome of recurrent VTE or any bleeding resulting in hospitalization for treatment of patients with CAT. |
| 2022-11-02 | Bristol-Myers Squibb | Results Data Reinforcing Impact of Bristol Myers Squibb Cardiovascular Portfolio to be Presented at American Heart Association Scientific Sessions 2022 bms.com ↗
Benefits of Apixaban Over Warfarin are Preserved Independent of Warfarin Time in Therapeutic Range: Insights From the AUGUSTUS Trial* |
| 2022-04-03 | Bayer | Results Bayer presents positive results from first Phase 2b trial on safety of asundexian in patients with atrial fibrillation bayer.com ↗
The results found that the bleeding rate for the primary endpoint (ISTH major and clinically relevant non-major bleeding) was reduced by 67% (incidence proportion of 0.33*) in patients receiving asundexian compared to those receiving apixaban. |
| 2021-10-04 | Norgine | Results New data in the European Heart Journal show ciraparantag reverses the anticoagulant activity of apixaban and rivaroxaban in elderly patients norgine.com ↗
Ciraparantag produced a rapid and dose-related reversal of anticoagulation induced by apixaban and rivaroxaban compared with placebo in 2 dose ranging studies in healthy elderly adults (age 50-75 years). |
| 2021-10-04 | Covis Pharma S.à.r.l. | Results New data in the European Heart Journal show ciraparantag reverses the anticoagulant activity of apixaban and rivaroxaban in elderly patients covispharma.com ↗
Ciraparantag produced a rapid and dose-related reversal of anticoagulation induced by apixaban and rivaroxaban compared with placebo in two dose ranging studies in healthy elderly adults (age 50-75 years). |
| 2019-12-07 | Pfizer | Results Findings Released from Real-World Data Analysis of Eliquis (apixaban) for the Treatment of Venous Thromboembolism in Patients with Active Cancer pfizer.com ↗
The Bristol-Myers Squibb-Pfizer Alliance today announced results from retrospective real-world data analyses reporting outcomes on the safety and effectiveness of Eliquis ® (apixaban) compared to low molecular weight heparin (LMWH) or warfarin for the treatment of venous thromboembolism (VTE) in patients with active cancer (n=14,086). |
| 2019-12-07 | Bristol-Myers Squibb | Results Findings Released from Real-World Data Analysis of Eliquis (apixaban) for the Treatment of Venous Thromboembolism in Patients with Active Cancer bms.com ↗
Eliquis was also associated with a lower rate of recurrent VTE (HR: 0.68, 95% CI: 0.52-0.90, p=0.007) and similar rates of major bleeding (HR: 0.73, 95% CI: 0.53-1.0, p=0.051) and CRNM bleeding (HR: 0.89, 95% CI: 0.77-1.04, p=0.145) compared to warfarin. |
| 2019-09-01 | Bristol-Myers Squibb | Results Findings Released from NAXOS, a French Real-World Data Analysis and the Largest Real-World Data Analysis on Oral Anticoagulant Effectiveness and Safety in Europe Among Patients with Non-Valvular Atrial Fibrillation bms.com ↗
Eliquis ® (apixaban) was associated with a lower rate of major bleeding, stroke and systemic thromboembolic events compared to a vitamin K antagonist |
| 2019-03-17 | Pfizer | Results AUGUSTUS Demonstrates Favorable Safety Results of Eliquis® Versus Vitamin K Antagonists in Non-Valvular Atrial Fibrillation Patients with Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention pfizer.com ↗ |
| 2019-03-17 | Bristol-Myers Squibb | Results AUGUSTUS Demonstrates Favorable Safety Results of Eliquis® Versus Vitamin K Antagonists in Non-Valvular Atrial Fibrillation Patients with Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention bms.com ↗ |
| 2018-11-11 | Bristol-Myers Squibb | Results Real-World Evidence on Patients Aged 80 and Older Presented From ARISTOPHANES, the Largest Real-World Data Study Evaluating Oral Anticoagulants Among Patients with Non-Valvular Atrial Fibrillation bms.com ↗
Eliquis ® (apixaban) was associated with lower rates of stroke or systemic embolism and major bleeding in elderly patient populations when compared to rivaroxaban and dabigatran |
| 2018-03-11 | Pfizer | Results Findings Released from Largest Real-World Data Analysis of Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants pfizer.com ↗
This is the largest RWD analysis reporting outcomes among different direct oral anticoagulants (DOACs), including Eliquis® (apixaban), rivaroxaban and dabigatran, to date. |
| 2018-03-11 | Bristol-Myers Squibb | Results Findings Released from Largest Real-World Data Analysis of Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants bms.com ↗
Eliquis ® (apixaban) use was associated with lower rates of stroke or systemic embolism and major bleeding than matched patients receiving rivaroxaban or dabigatran |
| 2017-08-29 | Pfizer | Results Bristol-Myers Squibb and Pfizer Alliance Announce Real-World Observational Analysis of the Effectiveness and Safety of Direct Oral Anticoagulants Compared to Warfarin in Elderly Patients with Non-Valvular Atrial Fibrillation pfizer.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced findings from a real-world data analysis of the U.S. Humana database, in which treatment with Eliquis® (apixaban) was associated with a significantly lower risk of stroke/systemic embolism and lower rates of major bleeding compared to warfarin in patients aged 65 years and older with non-valvular atrial fibrillation (NVAF). |
| 2017-08-29 | Bristol-Myers Squibb | Results Bristol-Myers Squibb and Pfizer Alliance Announce Real-World Observational Analysis of the Effectiveness and Safety of Direct Oral Anticoagulants Compared to Warfarin in Elderly Patients with Non-Valvular Atrial Fibrillation bms.com ↗ |
| 2017-08-28 | Pfizer | Results Bristol-Myers Squibb and Pfizer Present Investigational Eliquis® (apixaban) Data for Patients with Non-Valvular Atrial Fibrillation (NVAF) Undergoing Cardioversion pfizer.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today presented findings from EMANATE (Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with NVAF), a Phase 4 clinical trial, during a late-breaking hot line presentation at the ESC Congress 2017, organized by the European Society of Cardiology, in Barcelona, Spain. |
| 2017-08-28 | Bristol-Myers Squibb | Results Bristol-Myers Squibb and Pfizer Present Observational Real-World Data Analysis on the Effectiveness and Safety of Eliquis® (apixaban) Compared to Warfarin in Select High-Risk Patients with Non-Valvular Atrial Fibrillation bms.com ↗ |
| 2017-08-28 | Bristol-Myers Squibb | Results Bristol-Myers Squibb and Pfizer Present Investigational Eliquis® (apixaban) Data for Patients with Non-Valvular Atrial Fibrillation (NVAF) Undergoing Cardioversion bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today presented findings from EMANATE |
| 2017-08-27 | Pfizer | Results Bristol-Myers Squibb and Pfizer Present Observational Real-World Data Analysis on the Effectiveness and Safety of Eliquis® (apixaban) Compared to Warfarin in Select High-Risk Patients with Non-Valvular Atrial Fibrillation pfizer.com ↗
Among non-valvular atrial fibrillation (NVAF) patients, Eliquis ® (apixaban) was associated with a lower risk of stroke/SE and lower rates of major bleeding compared to warfarin for the overall population as well as for each of the selected high-risk patient sub-populations. |
| 2017-03-17 | Pfizer | Results Bristol-Myers Squibb and Pfizer Present Large Real-World Observational Analysis of the Effectiveness and Safety of Direct Oral Anticoagulants Compared to Warfarin in Patients with Non-Valvular Atrial Fibrillation pfizer.com ↗
In the analysis, titled Effectiveness and Safety of Apixaban, Dabigatran, and Rivaroxaban Compared to Warfarin among Non-Valvular Atrial Fibrillation Patients in the U.S. Medicare Population , Eliquis ® (apixaban) was associated with a significantly lower risk of stroke or systemic embolism and lower rate of major bleeding compared to warfarin. |
| 2017-03-17 | Bristol-Myers Squibb | Results Bristol-Myers Squibb and Pfizer Present Large Real-World Observational Analysis of the Effectiveness and Safety of Direct Oral Anticoagulants Compared to Warfarin in Patients with Non-Valvular Atrial Fibrillation bms.com ↗
In this U.S. Medicare database analysis, Eliquis ® (apixaban) was associated with significantly lower risk of stroke or systemic embolism and lower rate of major bleeding compared to warfarin |
| 2016-11-14 | Boehringer Ingelheim | Results First Data from Boehringer Ingelheim, Anthem and HealthCore Multi-Year Study Show Gaps in Non-valvular Atrial Fibrillation Care prnewswire.com ↗
Although treatment guidelines recommend OAC treatment for all NVAF patients at high stroke risk (i.e., CHADS 2 score ≥2), researchers found less than half (41.1 percent) of the study patients were treated with an OAC (warfarin, dabigatran, rivaroxaban or apixaban). |
| 2016-11-10 | Bristol-Myers Squibb | Results Bristol-Myers Squibb and Pfizer to Deliver 12 New Eliquis® (apixaban) Presentations at American Heart Association (AHA) Scientific Sessions 2016 bms.com ↗
Adherence and Persistence to Apixaban Treatment in Patients with Non-Valvular Atrial Fibrillation is High and Similar with Standard-of-care Patient Education or with an Additional Educational Program: The Randomized AEGEAN study |
| 2016-08-23 | Pfizer | Results Bristol-Myers Squibb and Pfizer to Present New Eliquis (apixaban) Analyses at ESC Congress 2016 pfizer.com ↗
Patients with Atrial Fibrillation and History of Falls Are at High Risk for Bleeding but Have Less Bleeding with Apixaban than Warfarin: Results from the ARISTOTLE Trial |
| 2015-12-10 | Pfizer | Results AMPLIFY Post-Hoc Early Time Course Analysis Evaluated Recurrent Venous Thromboembolism (VTE), VTE-Related Death and Major Bleeding in Deep Vein Thrombosis and Pulmonary Embolism Patients Treated with Eliquis (apixaban) or Conventional Therapy pfizer.com ↗
These findings indicate that the favorable benefit-to-risk profile of Eliquis was demonstrated early during treatment for VTE, including the use of a higher Eliquis dose of 10 mg twice daily for the initial seven days. |
| 2015-12-10 | Bristol-Myers Squibb | Results AMPLIFY Post-Hoc Early Time Course Analysis Evaluated Recurrent Venous Thromboembolism (VTE), VTE-Related Death and Major Bleeding in Deep Vein Thrombosis and Pulmonary Embolism Patients Treated with Eliquis (apixaban) or Conventional Therapy bms.com ↗
These findings indicate that the favorable benefit-to-risk profile of Eliquis was demonstrated early during treatment for VTE, including the use of a higher Eliquis dose of 10 mg twice daily for the initial seven days. |
| 2015-06-22 | Bristol-Myers Squibb | Results Portola, Bristol-Myers Squibb and Pfizer Announce Full Results of Second Part of Phase 3 ANNEXA-A™ Study Demonstrating that Investigational Andexanet Alfa Sustained Reversal of Anticoagulant Effect of Factor Xa Inhibitor Eliquis (apixaban) bms.com ↗
Andexanet alfa produced rapid reversal of the anticoagulant effect of Eliquis , as measured by anti-Factor Xa activity, which was sustained for the duration of the infusion. |
| 2015-03-16 | Boehringer Ingelheim | Results New Data from Boehringer Ingelheim's GLORIA™-AF Registry Show Non-Valvular Atrial Fibrillation (NVAF) Patients at High Risk of Stroke May Be Undertreated prnewswire.com ↗
Newer drugs known as novel oral anticoagulants (NOACs) accounted for 52.1 percent of anticoagulants prescribed (25.0 percent dabigatran, 20.5 percent rivaroxaban, and 6.6 percent apixaban). |
| 2014-12-08 | Bristol-Myers Squibb | Results Anticoagulant Effect of Eliquis (apixaban) Reversed by Two Separate 4-Factor Prothrombin Complex Concentrates in Healthy Subjects bms.com ↗
The study results demonstrated that both PCCs, Sanquin’s Cofact (a heparin-free formulation) and CSL Behring’s Beriplex P/N (a formulation containing heparin) reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential (ETP). |
| 2014-11-17 | Bristol-Myers Squibb | Results Portola, Bristol-Myers Squibb and Pfizer Announce Statistically Significant Results from the First Part of the Phase 3 ANNEXA™-A Studies of Investigational Andexanet Alfa with Eliquis (apixaban) bms.com ↗
Andexanet alfa produced rapid and nearly complete reversal (by approximately 94 percent, p value < 0.0001) of the anticoagulant effect of Eliquis (apixaban) in healthy volunteers ages 50-75. |
| 2014-08-30 | Bristol-Myers Squibb | Results Secondary Analysis of AMPLIFY-EXT Examining Predictors of Hospitalization Presented at ESC Congress: Eliquis (apixaban) Significantly Reduced the Risk of All-Cause Hospitalization Versus Placebo in Patients with Venous Thromboembolism (VTE) bms.com ↗
Results from this analysis demonstrated that during the 12-month extended treatment of VTE, Eliquis significantly reduced the risk of hospitalization versus placebo. |
| 2014-08-21 | Bristol-Myers Squibb | Regulatory U.S. FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and for the Reduction in the Risk of Recurrent DVT and PE Following Initial Therapy bms.com ↗ |
| 2014-07-29 | Bristol-Myers Squibb | Regulatory European Commission Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Prevention of Recurrent DVT and PE bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved Eliquis for the treatment of DVT and PE, and the prevention of recurrent DVT and PE in adults. |
| 2014-06-27 | Bristol-Myers Squibb | Regulatory Eliquis® (apixaban) Receives CHMP Positive Opinion for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Prevention of Recurrent DVT and PE bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Eliquis (apixaban) be granted marketing authorization for the treatment of DVT (deep vein thrombosis) and PE (pulmonary embolism), and the prevention of recurrent DVT and PE, in adults. |
| 2014-03-27 | Bristol-Myers Squibb | Results In A Subanalysis, The Benefits Of Eliquis® (apixaban) Vs. Warfarin In Reducing The Risk Of Stroke In Patients With Nonvalvular Atrial Fibrillation Were Consistent, Regardless Of Blood Pressure Control 1 bms.com ↗
However, this subanalysis found consistent results for Eliquis versus warfarin in reducing the risk of stroke, regardless of blood pressure control. |
| 2014-03-14 | Bristol-Myers Squibb | Regulatory U.S. FDA Approves Eliquis® (apixaban) To Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery bms.com ↗
“Today’s FDA approval of Eliquis for DVT prophylaxis in patients who have undergone hip or knee replacement is a significant milestone for this important medicine, which is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation,” said Brian Daniels, M.D ., senior vice president, global development and medical affairs, Bristol-Myers Squibb. |
| 2014-02-21 | Bristol-Myers Squibb | Results In a Subanalysis, Eliquis® (apixaban) Reduced the Risk of Stroke and Demonstrated Fewer Major Bleeding Events versus Warfarin Consistently across Age Groups, Including Older Patients with Nonvalvular Atrial Fibrillation bms.com ↗
Eliquis was more effective than warfarin in reducing the risk of stroke and reducing mortality across age groups, and was associated with less major bleeding, less total bleeding and less intracranial hemorrhage, regardless of age. |
| 2013-12-19 | Bristol-Myers Squibb | Regulatory FDA Accepts For Review ELIQUIS® (apixaban) Supplemental New Drug Application for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and for the Reduction in the Risk of Recurrent DVT and PE bms.com ↗
the U.S. Food and Drug Administration (FDA) has accepted for review a Supplemental New Drug Application (sNDA) |
| 2013-09-03 | Bristol-Myers Squibb | Results Subanalysis of Phase III ARISTOTLE Trial of Eliquis® (apixaban) Demonstrated Consistent Results Versus Warfarin in Patients with Nonvalvular Atrial Fibrillation with or without Valvular Heart Disease bms.com ↗
Data show consistent results in reductions in stroke or systemic embolism, fewer major bleeding events, and reductions in all-cause death |
| 2013-08-31 | Bristol-Myers Squibb | Results New Eliquis® (apixaban) Post-hoc Subanalysis of the Phase III ARISTOTLE trial Demonstrated that within 30 Days of a Procedure, Stroke or Systemic Embolism and Major Bleeding were Uncommon bms.com ↗
The results showed that in the 30-day period following a procedure, rates of clinical events (stroke or systemic embolism, major bleeding, and all-cause death) were comparable in the Eliquis and warfarin treatment arms. |
| 2013-07-25 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Reports Second Quarter 2013 Financial Results bms.com ↗
Completes Regulatory Filing in U.S. for Eliquis ® for the Prevention of DVT After Hip or Knee Replacement Surgery |
| 2013-07-11 | Bristol-Myers Squibb | Regulatory FDA Accepts Eliquis® (apixaban) Supplemental New Drug Application for Review for Prophylaxis of Deep Vein Thrombosis Following Hip Or Knee Replacement Surgery bms.com ↗ |
| 2013-06-30 | Bristol-Myers Squibb | Results Eliquis® (apixaban) Demonstrated Comparable Efficacy and Significantly Lower Rates of Major Bleeding in Patients Compared to Current Standard of Care for the Treatment of Acute Venous Thromboembolism bms.com ↗
In this trial, Eliquis as a single-agent achieved the primary efficacy endpoint of noninferiority to current standard of care (initial parenteral enoxaparin treatment overlapped with warfarin therapy) in the reduction of the composite endpoint of recurrent symptomatic VTE or VTE-related death. |
| 2013-05-06 | Bristol-Myers Squibb | Results Bristol-Myers Squibb and Pfizer Announce Publication of ARISTOTLE Subanalysis in Circulation bms.com ↗
Subgroup analysis demonstrates that the treatment effects of Eliquis ® (apixaban) vs. warfarin, across a broad range of warfarin control, are consistent with primary results of ARISTOTLE |
| 2013-01-02 | Bristol-Myers Squibb | Regulatory U.S. FDA Approves ELIQUIS® (apixaban) to Reduce the Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) approved ELIQUIS ® (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. |
| 2012-12-28 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb and Pfizer Announce U.S. FDA Approval of ELIQUIS® (apixaban) bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved ELIQUIS ® (apixaban). |
| 2012-12-26 | Bristol-Myers Squibb | Regulatory ELIQUIS® (apixaban) Approved In Japan For The Prevention Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation bms.com ↗
“The approval in Japan marks the third regulatory approval for ELIQUIS within six weeks,” said John Young, president and managing director, Pfizer Primary Care Business Unit. |
| 2012-12-08 | Bristol-Myers Squibb | Results ELIQUIS® (apixaban) Demonstrated Superiority In Reducing A Composite Of Recurrent Venous Thromboembolism And All-Cause Death Without Increasing The Rate Of Major Bleeding Versus Placebo During One Year Of Extended Treatment bms.com ↗
ELIQUIS also was superior to placebo for the predefined secondary efficacy outcome of recurrent VTE and VTE-related death (8.8% in the placebo group, compared with 1.7% in both the ELIQUIS 2.5 mg and 5 mg groups). |
| 2012-11-20 | Bristol-Myers Squibb | Regulatory ELIQUIS®(apixaban) Approved in Europe for Prevention of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation bms.com ↗
This is the first regulatory approval in any market for ELIQUIS for stroke prevention in patients with nonvalvular atrial fibrillation. |
| 2012-10-01 | Bristol-Myers Squibb | Results ELIQUIS® (apixaban) Demonstrates Consistent Reductions in Stroke and Systemic Embolism, Major Bleeding and Mortality Compared to Warfarin in Patients with Nonvalvular Atrial Fibrillation at Varying Risk for Stroke and Bleeding bms.com ↗
“These findings suggest that, due to the consistent benefit of apixaban versus warfarin, current risk-scoring systems for selecting anticoagulation therapy may be less relevant when using apixaban than they are for warfarin, at least for patients with CHADS 2 scores ≥1.” |
| 2012-09-26 | Bristol-Myers Squibb | Regulatory FDA Acknowledges Receipt of Resubmission of the ELIQUIS® (apixaban) New Drug Application to Reduce the Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation bms.com ↗
The FDA has deemed the resubmission a complete response to its June 22, 2012 Complete Response Letter that requested additional information on data management and verification from the ARISTOTLE trial. |
| 2012-09-21 | Bristol-Myers Squibb | Regulatory ELIQUIS® (apixaban) Receives CHMP Positive Opinion For The Prevention Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation bms.com ↗
Bristol-Myers Squibb (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that ELIQUIS ® (apixaban) be granted approval for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) and one or more risk factors for stroke. |
| 2012-06-25 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb and Pfizer Receive Complete Response Letter from U.S. Food and Drug Administration for ELIQUIS® (apixaban) bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ELIQUIS ® (apixaban) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. |
| 2012-02-29 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Extends Action Date for ELIQUIS® (apixaban) by Three Months bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the New Drug Application (NDA) for Eliquis ® (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. |
| 2011-11-29 | Bristol-Myers Squibb | Regulatory FDA Accepts ELIQUIS® (apixaban) New Drug Application for Review for the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation bms.com ↗
The FDA accepted the filing and assigned a priority-review designation. |
| 2011-08-28 | Bristol-Myers Squibb | Results ELIQUIS® (apixaban) was Superior to Warfarin for the Reduction of Stroke or Systemic Embolism with Significantly Less Major Bleeding in Patients with Atrial Fibrillation in Phase 3 ARISTOTLE Trial bms.com ↗
In the ARISTOTLE trial, ELIQUIS as compared with warfarin significantly reduced the risk of stroke or systemic embolism by 21 percent, major bleeding by 31 percent, and mortality by 11 percent. |
| 2011-06-22 | Bristol-Myers Squibb | Results ELIQUIS® (apixaban) Meets Primary and Key Secondary Endpoints in Phase 3 ARISTOTLE Study bms.com ↗
In addition, ELIQUIS met the key secondary endpoints of superiority on efficacy and on ISTH (International Society on Thrombosis and Haemostasis) major bleeding compared to warfarin. |
| 2011-05-20 | Bristol-Myers Squibb | Regulatory ELIQUIS® (apixaban) Approved In Europe For Preventing Venous Thromboembolism After Elective Hip Or Knee Replacement bms.com ↗
The European Commission has approved ELIQUIS ® in the 27 countries of the European Union (EU) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. |
| 2011-02-10 | Bristol-Myers Squibb | Results New AVERROES Data Demonstrate Investigational Apixaban Superior to Aspirin in Reducing Stroke and Systemic Embolism in Patients with Atrial Fibrillation Unsuitable for Warfarin Therapy bms.com ↗
The study results also showed that apixaban demonstrated superiority for its secondary efficacy endpoint in reducing the composite of stroke, systemic embolism, myocardial infarction or vascular death for patients with AF when compared with aspirin. |
| 2010-12-22 | Bristol-Myers Squibb | Results Newly Published Investigational Apixaban ADVANCE-3 Study Results Demonstrate Statistical Superiority to Enoxaparin with Comparable Rates of Bleeding in the Prevention of Venous Thromboembolism Following Total Hip Replacement Surgery bms.com ↗ |
| 2010-11-18 | Bristol-Myers Squibb | Results APPRAISE-2 Study with Investigational Compound Apixaban in Acute Coronary Syndrome Discontinued bms.com ↗
There was clear evidence of a clinically important increase in bleeding among patients randomized to apixaban. |
| 2010-06-10 | Bristol-Myers Squibb | Results AVERROES Study of Investigational Agent Apixaban Closes Early Due to Clear Evidence of Efficacy bms.com ↗
This interim analysis also demonstrated an acceptable safety profile for apixaban compared to aspirin. |
| 2010-03-04 | Bristol-Myers Squibb | Results ADVANCE-2 Study Results Demonstrate Investigational Anticoagulant Apixaban Was Statistically Superior to Enoxaparin in the Prevention of Venous Thromboembolism Following Knee Replacement Surgery bms.com ↗
The study results also showed numerically lower rates of major and clinically relevant non-major bleeding in patients treated with apixaban compared with those treated with enoxaparin. |
| 2008-09-02 | Bristol-Myers Squibb | Results New Data is Presented on Investigational Oral Anticoagulant Apixaban in Acute Coronary Syndrome Patients bms.com ↗
The study results were presented during a late-breaking session at the annual European Society of Cardiology (ESC) meeting in Munich, Germany. |
| 2008-08-26 | Bristol-Myers Squibb | Results Bristol-Myers Squibb and Pfizer Provide Update on Apixaban Clinical Development Program bms.com ↗
The rate of the primary efficacy endpoint on apixaban was numerically similar to that observed with enoxaparin (9.0% vs. 8.9%, p=.064), but did not meet the pre-specified statistical criteria for non-inferiority compared to enoxaparin. |
All press releases naming this drug 99 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 268 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Apixaban | “Pharmacologic therapy includes rate control with beta-blockers (e.g., bisoprolol), calcium channel blockers (e.g., diltiazem), or antiarrhythmic drugs (e.g., flecainide,...” NCT06699342 ↗264“Patients will be chronically treated with NOAC including apixaban (2x5 mg or 2x2.5 mg depending on the dose reduction regimen) or dabigatran (2x150 mg or 2x110 mg depending on...” NCT06212674 ↗ “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 ↗ “For those randomized to group B (NOAC group), patients will be treated using a registered NOAC (rivaroxaban, apixaban or dabigatran, but preferentionally apixaban) at the dose...” NCT02426944 ↗ “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 ↗ “Upon enrollment and during follow-up, patients will be managed with a prophylactic dose of apixaban (2.5 mg orally twice daily) as long as either a central venous catheter...” NCT06603870 ↗ “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 ↗ “Participants in the continuation arm will receive oral anticoagulant drugs such as dabigatran, rivaroxaban, apixaban, warfarin, etc. tailored to their specific risk profiles.” NCT06615596 ↗ “Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) or rivaroxaban 20mg once daily (15mg once daily if meets dose-reduction criteria) for 2 years” NCT04437654 ↗ “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 ↗ |
| Known as | Apixaban (Eliquis) | “Apixaban (Eliquis)” NCT03465735 ↗ |
| Known as | Apixaban IR | “Drug: Apixaban IR” NCT00914641 ↗ |
| Known as | Apixaban MR1 | “Drug: Apixaban MR1” NCT00914641 ↗ |
| Known as | Apixaban MR2 | “Drug: Apixaban MR2” NCT00914641 ↗ |
| Known as | Apixaban MR3 | “Drug: Apixaban MR3” NCT00914641 ↗ |
| Known as | Apixiban | “The name of the study drug involved in this study is: -Apixiban (a type of anticoagulant)” NCT06886516 ↗ |
| Known as | Eliquis | “This study will test different ways of using a commonly prescribed blood thinner called apixaban (brand name Eliquis) to see if it can safely and effectively reduce the risk of...” NCT07005024 ↗9“Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)” NCT03148457 ↗ “novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.” NCT02504177 ↗ “The two most commonly-used anticoagulants will be compared: apixaban (Eliquis) and rivaroxaban (Xarelto).” NCT06953726 ↗ “Vascular treatments may include: antihypertensives, Ubrelvy, aspirin, Eliquis” NCT05894954 ↗ “Apixaban (Eliquis) at 2.5mg, per os, twice a day” NCT06045858 ↗ “Apixaban 2.5 MG Oral Tablet [ELIQUIS]” NCT04981327 ↗ “Apixaban 5 MG [Eliquis]” NCT05869591 ↗ “Apixaban (Eliquis)” NCT06729034 ↗ |
| Known as | Eliquis 2,5mg | “Apixaban 2.5mg (i.e Eliquis® 2,5mg tablet) orally twice daily for 28 days (with standard of care mechanical prophylaxis)” NCT06523959 ↗ |
| Known as | TAH3311 | “A Pivotal, Randomized, Single-dose, Open-label, Four-Way Crossover, BE Study of TAH3311 (Apixaban ODF) Under Fasted and Fed Conditions vs. ELIQUIS® Oral Tablet Under Fasted...” NCT06689436 ↗ |
| Action | Inhibit | “oral Factor Xa inhibitor BMS-562247” NCT00097357 ↗ |
| Modality | Small molecule | “Apixaban is an oral small-molecule, direct factor Xa (FXa) inhibitor approved in adults for treatment of deep vein thrombosis and pulmonary embolism, and for reducing risk of...” PMID 36861188 ↗ Mar 2023 |
| Route | Oral | “Tablets, Oral, 12 +/- 2 days” NCT00097357 ↗ |