rivaroxaban
Trade name: xarelto
Small moleculeapproved
Approved
Jul 1, 2011
Rivaroxaban (trade name Xarelto) is an oral anticoagulant. It is the first available orally active direct factor Xa inhibitor. Upon oral administration, rivaroxaban selectively binds to both free factor Xa and factor Xa bound in the prothrombinase complex. This interferes with the conversion of prothrombin (factor II) to thrombin and eventually prevents the formation of cross-linked fibrin clots. Rivaroxaban does not affect existing thrombin levels. Activation of factor X to factor Xa (FXa) via the intrinsic and extrinsic pathways plays a central role in the cascade of blood coagulation. Xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment and prophylaxis of deep vein thrombosis (DVT) which may lead to PE in patients undergoing knee or hip replacement surgery, pulmonary embolism (PE) and for the reduction in the risk of recurrence of deep vein thrombosis and of pulmonary embolism following initial 6 months treatment for DVT and/or PE. — NCATS
Clinical trial activity
346 trials · 332 clinical orgs · 20 marketing orgs
Phase 1
56
Phase 2
146
Phase 3
122
Phase 4
100
Earliest trial started Dec 1, 2002 (NCT00839826)
Timeline
2000s
2010s
- Jul 1, 2011
Johnson and Johnson — Earliest FDA Approval
- Jul 1, 2011
Johnson and Johnson — NDA Secondary Org
- Jul 1, 2011
Johnson and Johnson — NDA Organization
- May 16, 2019
Prinston Inc — Marketing Organization
2020s
- Jun 27, 2022
Mylan — Marketing Organization
- Oct 17, 2023
Alembic — Marketing Organization
- Nov 3, 2023
Taro Pharmaceuticals — Marketing Organization
- Jan 22, 2024
Lupin — Marketing Organization
- Nov 12, 2024
Dr. Reddy's Laboratories — Marketing Organization
- Apr 10, 2025
Aurobindo Pharma — Marketing Organization
- May 2, 2025
Apotex — Marketing Organization
- May 14, 2025
Ascent Pharmahealth — Marketing Organization
- May 14, 2025
Biocon Limited — Marketing Organization
- May 14, 2025
Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd. — Marketing Organization
- May 14, 2025
Invagen Pharms — Marketing Organization
- May 14, 2025
Macleods Pharmaceuticals, Ltd — Marketing Organization
- May 14, 2025
Sunshine Lake Pharma Co., Ltd. — Marketing Organization
- May 15, 2025
Esteve Labs — Marketing Organization
- Jun 26, 2025
Alkem Labs Ltd — Marketing Organization
- Jul 31, 2025
Sciegen Pharmaceticals — Marketing Organization
- Aug 11, 2025
Indoco Remedies — Marketing Organization
Indications
Approved for
Studied for
- Acute Coronary Syndrome · Phase 4
- Anemia, Sickle Cell · Phase 3
- Aneurysm · Phase 4
- Angina, Stable · Phase 4
- Angina, Unstable · Phase 4
- Anticoagulants · Phase 4
- Antiphospholipid Syndrome · Phase 4
- Aortic Valve Disease · Phase 2
- Aortic Valve Insufficiency · Phase 4
- Aortic Valve Stenosis · Phase 4
- Appendix · Phase 4
- Arthritis · Phase 3
- Arthroplasty · Phase 4
- Atherosclerosis · Phase 4
- Atrial Appendage · Phase 2/Phase 3
- Atrial Fibrillation · Phase 4
- Atrial Flutter · Phase 4
- Bariatric Surgery · Phase 2
- Behcet Syndrome · Phase 3
- beta-Thalassemia · Phase 2
- Biological Availability · Phase 1
- Blood Coagulation · Phase 1
- Blood Loss, Surgical · Phase 4
- Brain Ischemia · Phase 2/Phase 3
- Breast Feeding · Phase 1
- Breast Milk Expression · Phase 1
- Breast Neoplasms · Phase 1
- Carcinoma, Hepatocellular · Phase 2
- Cardiomyopathies · Phase 4
- Cardiovascular Diseases · Phase 4
- Carotid Stenosis · Phase 4
- Cerebral Hemorrhage · Phase 3
- Cerebral Infarction · Phase 4
- Cerebral Intraventricular Hemorrhage · Phase 3
- Cerebrovascular Disorders · Phase 3
- Chronic Limb-Threatening Ischemia · Phase 2
- Colonic Neoplasms · Phase 4
- Communicable Diseases · Phase 3
- Constriction, Pathologic · Phase 2/Phase 3
- Coronary Aneurysm · Phase 3
- Coronary Artery Disease · Phase 4
- Coronary Disease · Phase 4
- Coronavirus Infections · Phase 4
- COVID-19 · Phase 4
- Diabetes Mellitus · Phase 4
- Drug Interactions · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 3
- Drug Therapy · Phase 1
- Duodenal Neoplasms · Phase 2
- Electric Countershock · Phase 3
- Embolism · Phase 4
- Embolism and Thrombosis · Phase 4
- Esophageal Neoplasms · Phase 2
- Femoral Neck Fractures · Phase 4
- Femur Head Necrosis · Phase 4
- Fibrinolytic Agents · Phase 3
- Fibrosis · Phase 3
- Foramen Ovale, Patent · Phase 4
- Gastric Bypass · Phase 1
- General Surgery · Phase 4
- Healthy Volunteers · Phase 2/Phase 3
- Heart Failure · Phase 4
- Heart Valve Diseases · Phase 3
- Heart Valve Prosthesis Implantation · Phase 2
- Hematoma · Phase 3
- Hematoma, Subdural · Phase 3
- Hemodialysis, Home · Phase 3
- Hemorrhage · Phase 4
- Hip Fractures · Phase 3
- Hypertension, Portal · Phase 1/Phase 2
- Hypertrophy, Left Ventricular · Phase 4
- Immobilization · Phase 3
- Immune System Diseases · Phase 1
- Immunotherapy · Phase 1
- Inflammation · Phase 1
- Intermittent Claudication · Phase 4
- Intestinal Neoplasms · Phase 2
- Intracranial Arteriosclerosis · Phase 2/Phase 3
- Intracranial Embolism · Phase 4
- Intracranial Hemorrhage, Hypertensive · Phase 3
- Intracranial Hemorrhages · Phase 3
- Ischemic Attack, Transient · Phase 4
- Ischemic Stroke · Phase 4
- Kidney Failure, Chronic · Phase 4
- Laparoscopy · Phase 4
- Leg Injuries · Phase 3
- Liver Cirrhosis · Phase 1/Phase 2
- Lung Diseases · Phase 4
- Lung Neoplasms · Phase 1
- Lupus Erythematosus, Systemic · Phase 2/Phase 3
- May-Thurner Syndrome · Phase 3
- Menstruation · Phase 2/Phase 3
- Migraine Disorders · Phase 4
- Mitral Valve Insufficiency · Phase 4
- Mitral Valve Stenosis · Phase 4
- Mucocutaneous Lymph Node Syndrome · Phase 4
- Multiple Myeloma · Phase 3
- Myocardial Infarction · Phase 4
- Myocardial Ischemia · Phase 4
- Neoplasms · Phase 4
- Non-ST Elevated Myocardial Infarction · Phase 4
- No-Reflow Phenomenon · Phase 4
- Obesity, Morbid · Phase 1
- Osteoarthritis, Hip · Phase 4
- Osteoarthritis, Knee · Phase 4
- Ovarian Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 2
- Pediatrics · Phase 1
- Percutaneous Coronary Intervention · Phase 3
- Peripheral Arterial Disease · Phase 4
- Pharmacokinetics · Phase 1
- Pharmacology, Clinical · Phase 1
- Pilot Projects · Phase 4
- Postpartum Period · Phase 1
- Postthrombotic Syndrome · Phase 4
- Prostatic Neoplasms · Phase 1
- Prostheses and Implants · Phase 2/Phase 3
- Pulmonary Embolism · Phase 4
- Radial Artery · Phase 4
- Recurrence · Phase 4
- Renal Insufficiency · Phase 3
- Renal Insufficiency, Chronic · Phase 4
- Respiratory Insufficiency · Phase 3
- Respiratory Tract Diseases · Phase 4
- Rheumatic Diseases · Phase 3
- Rheumatic Heart Disease · Phase 3
- Rivaroxaban · Phase 4
- Staphylococcal Infections · Phase 4
- Staphylococcus aureus · Phase 4
- ST Elevation Myocardial Infarction · Phase 4
- Stomach Neoplasms · Phase 2
- Stroke · Phase 4
- Subarachnoid Hemorrhage · Phase 3
- Therapeutic Equivalency · Phase 1
- Thrombocytopenia · Phase 3
- Thromboembolism · Phase 4
- Thrombosis · Phase 4
- Transcatheter Aortic Valve Replacement · Phase 3
- Upper Extremity Deep Vein Thrombosis · Phase 4
- Urinary Bladder Neoplasms · Phase 2
- Urologic Neoplasms · Phase 2/Phase 3
- Vascular Calcification · Phase 4
- Vascular Grafting · Phase 3
- Venous Cutdown · Phase 4
- Venous Thromboembolism · Phase 4
- Venous Thrombosis · Phase 4
- Ventricular Outflow Obstruction · Phase 3
- Warfarin · Phase 3
- Wounds and Injuries · Phase 3
Mechanism of action
- Coagulation factor XANTAGONIST
F10 antagonist
Approval history
- approvedJul 1, 2011
Chemistry & pharmacology
Loading structure…
SMILES
ClC1=CC=C(S1)C(=O)NC[C@H]2CN(C(=O)O2)C3=CC=C(C=C3)N4CCOCC4=O- Mol. weight
- 435.881 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Black box warningFirst in class
Sources
- WikipediaRivaroxaban ↗
- NCATS9NDF7JZ4M3 ↗
- ChEMBLCHEMBL198362 ↗
Also known as
- bay-59-7939
- bay-59-7939
- rivaraxaban
- rivaroxaban
- rivaroxaban
- rivaroxaban
- rivaroxaban
- rivaroxaban
- rivaroxaban
- rivaroxaban
- rivaroxaban
- rivaroxaban
- rivaroxaban
- xarelto
- xarelto
- xarelto
- xarelto
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07312851 | Phase 1 | Jan 12, 2026 | AstraZeneca, Parexel |
| NCT07246005 | Phase 2 | Dec 1, 2025 | University of London |
| NCT07228663 | Phase 3 | Dec 1, 2025 | Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, McMaster University |
| NCT07195812 | Phase 4 | Oct 31, 2025 | Nanchang University, Wenzhou Medical University, Zhejiang University |
| NCT07243080 | Phase 4 | Oct 10, 2025 | King Edward Medical University, Mayo Clinic |
| NCT06961630 | Early Phase 1 (Phase 1) | Oct 7, 2025 | National Heart, Lung, and Blood Institute (NHLBI), New York University |
| NCT07202897 | Phase 3 | Oct 1, 2025 | University of Rennes |
| NCT06965998 | Phase 2/Phase 3 (Phase 3) | Aug 6, 2025 | University of Ottawa |
| NCT06953726 | Phase 4 | Jun 2, 2025 | Department of Veteran Affairs, Food and Drug Administration |
| NCT06901466 | Phase 4 | May 1, 2025 | Chinese Academy of Medical Sciences |
| NCT06925698 | Phase 3 | Apr 30, 2025 | Government of Turkey, Marmara University |
| NCT06831474 | Phase 1 | Apr 1, 2025 | Thomas Jefferson University |
| NCT06812455 | Phase 4 | Mar 1, 2025 | Aristotle University of Thessaloniki |
| NCT06780462 | Phase 3 | Jan 15, 2025 | Assistance Publique - Hôpitaux de Paris |
| NCT06650501 | Phase 4 | Jan 7, 2025 | McGill University, University of Melbourne |
| NCT06862726 | Phase 4 | Dec 1, 2024 | Les Laboratoires des Médicaments Stériles |
| NCT06396858 | Phase 4 | Nov 30, 2024 | Brazilian Clinical Research Institute |
| NCT07270263 | N/A | Nov 22, 2024 | Medical University of Gdansk |
| NCT06370273 | Phase 3 | Nov 12, 2024 | University of London |
| NCT06689241 | N/A | Oct 1, 2024 | Alexandria University |
Showing 20 of 346 trials
Page 1 / 18
Organizations
Research & Development (332)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bayer | For profit | 93 | 47 | 4 | 2002 |
| Johnson and Johnson | For profit | 43 | 19 | 4 | 2004 |
| Janssen Pharmaceutica NV | For profit | 22 | 1 | 4 | 2007 |
| University of Ottawa | Academic/Hospital | 16 | 12 | 3 | 2013 |
| McMaster University | Academic/Hospital | 13 | 9 | 2 | 2013 |
| University of Bern | Academic/Hospital | 10 | 10 | 5 | 2012 |
| Canadian Institutes of Health Research (CIHR) | Academic/Hospital | 8 | 0 | 2 | 2013 |
| Fudan University | Academic/Hospital | 7 | 5 | 3 | 2017 |
| Jiao Tong University | Academic/Hospital | 6 | 4 | 3 | 2018 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 6 | 0 | 4 | 2012 |
| Zhejiang University | Academic/Hospital | 6 | 6 | 3 | 2019 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 5 | 4 | 2 | 2021 |
| University of London | Academic/Hospital | 5 | 3 | 3 | 2019 |
| University of Paris | Academic/Hospital | 5 | 4 | 1 | 2007 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 4 | 4 | 2 | 2017 |
| Hamilton Health Sciences Corporation | Academic/Hospital | 4 | 0 | 2 | 2014 |
| Science Valley Research Institute | For profit | 4 | 4 | 2 | 2020 |
| Seoul National University | Academic/Hospital | 4 | 3 | 3 | 2013 |
| University of Lyon | Academic/Hospital | 4 | 4 | 2 | 2015 |
| Aalborg University | Academic/Hospital | 3 | 1 | 3 | 2017 |
332 organizations
Page 1 / 17
Marketing (24)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Alembic | For profit | MKTG | Oct 17, 2023 |
| Alembic | For profit | SYN | May 14, 2025 |
| Alkem Labs Ltd | For profit | MKTG | Jun 26, 2025 |
| Apotex | For profit | MKTG | May 2, 2025 |
| Ascent Pharmahealth | For profit | MKTG | May 14, 2025 |
| Aurobindo Pharma | For profit | MKTG | Apr 10, 2025 |
| Bayer | For profit | IND | May 29, 2002 |
| Biocon Limited | For profit | MKTG | May 14, 2025 |
| Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd. | For profit | MKTG | May 14, 2025 |
| Dr. Reddy's Laboratories | For profit | MKTG | Nov 12, 2024 |
| Dr. Reddy's Laboratories | For profit | SYN | May 14, 2025 |
| Esteve Labs | For profit | MKTG | May 15, 2025 |
| Indoco Remedies | For profit | MKTG | Aug 11, 2025 |
| Invagen Pharms | For profit | MKTG | May 14, 2025 |
| Johnson and Johnson | For profit | NDA2 | Jul 1, 2011 |
| Johnson and Johnson | For profit | NDA | Jul 1, 2011 |
| Lupin | For profit | MKTG | Jan 22, 2024 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | May 14, 2025 |
| Mylan | For profit | MKTG | Jun 27, 2022 |
| Prinston Inc | For profit | MKTG | May 16, 2019 |
| Sciegen Pharmaceticals | For profit | MKTG | Jul 31, 2025 |
| Sunshine Lake Pharma Co., Ltd. | For profit | MKTG | May 14, 2025 |
| Taro Pharmaceuticals | For profit | MKTG | Nov 3, 2023 |
| Taro Pharmaceuticals | For profit | SYN | Mar 3, 2025 |