Rivaroxaban
Other / unclassified targets F10 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 18 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed limb ischemia 1 milestone | |||||
| Filed | US (FDA) | Xarelto | limb ischemia | 2017-12-11 | “has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the rivaroxaban (Xarelto®) vascular dose” bayer.com ↗ “Janssen Submits Supplemental New Drug Application to FDA Seeking New Indications for XARELTO® (rivaroxaban)” jnj.com ↗ |
| Filed peripheral arterial occlusive disease 1 1 milestone | |||||
| Filed | EU (EMA) | Xarelto | peripheral arterial occlusive disease 1 | 2017-11-06 | “Bayer has submitted an application to the European Medicines Agency (EMA) for the marketing authorization of the vascular dose of its Factor Xa inhibitor rivaroxaban” bayer.com ↗ |
| Filed venous thromboembolism 3 milestones | |||||
| Filed | US (FDA) | Xarelto | venous thromboembolism | 2021-06-23 | “announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO®(rivaroxaban) in pediatric patients.” jnj.com ↗ |
| Filed | US (FDA) | XARELTO® | venous thromboembolism | 2018-12-14 | “A supplemental New Drug Application was submitted to the FDA seeking to broaden the use of XARELTO (rivaroxaban) for the prevention of venous thromboembolism (VTE), or blood...” jnj.com ↗ “Janssen Submits Supplemental New Drug Application (sNDA) to FDA for XARELTO® (rivaroxaban) to Prevent Venous Thromboembolism (VTE) in Acute Medically Ill Patients” jnj.com ↗ |
| Filed | US (FDA) | Xarelto | venous thromboembolism | 2017-05-01 | “a supplemental New Drug Application was submitted to the FDA to update the prescribing information for XARELTO (rivaroxaban)” jnj.com ↗ “UNIVERSE data are included in recent New Drug Application to FDA for two new pediatric indications for rivaroxaban” bayer.com ↗ “included ina recent New Drug Applicationsubmitted to the U.S. Food and Drug Administration” jnj.com ↗ |
| Rejected acute coronary syndrome 2 milestones | |||||
| Rejected (CRL) | US (FDA) | XARELTO® | acute coronary syndrome | 2013-06-28 | “FDA Issues Complete Response Letter for XARELTO ® (rivaroxaban) to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome” jnj.com ↗ |
| Rejected (CRL) | US (FDA) | XARELTO® | acute coronary syndrome | 2013-03-04 | “FDA Issues Complete Response Letter for XARELTO ® (rivaroxaban) for the Reduction of Cardiovascular Events in Patients with Acute Coronary Syndrome” jnj.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (8) | US (FDA) | XARELTO | — | 2012-11-02 – 2021-08-23 | fda.gov ↗ |
| Filed | EU (EMA) | Xarelto | venous thromboembolism in children | 2019-11-25 | “Bayer has submitted an application to the European Medicines Agency (EMA) to extend the Xarelto marketing authorization” bayer.com ↗ |
| Approved | US (FDA) | XARELTO | — | 2011-07-01 | fda.gov ↗ |
| Approved | EU (EMA) | Xarelto | — | 2008-09-30 | europa.eu ↗ |
Trials 283 · started per year
News releases announcing trial results or a regulatory action · 96
| Date | Issuer | Release |
|---|---|---|
| 2025-09-30 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Rivaroxaban for Oral Suspension lupin.com ↗ |
| 2025-05-15 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg lupin.com ↗ |
| 2025-05-01 | Alembic Pharmaceuticals Ltd. | Regulatory 15th May, 2025 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg. |
| 2025-03-07 | Lupin Limited | Regulatory Lupin Launches Rivaroxaban Tablets USP, 2.5mg in the United States lupin.com ↗
Mumbai, Naples, March 07, 2025: Global pharma major Lupin Limited (Lupin) today announced that it has launched Rivaroxaban Tablets USP, 2.5 mg, following the final approval of its Abbreviated New Drug Application from the U.S. FDA. |
| 2024-04-08 | Janssen Research & Development, LLC | Results Findings Presented at ACC.24 Showed XARELTO® (rivaroxaban) Reduced the Risk of Clinically Significant Bleeding and Net Adverse Clinical Events or Rehospitalization jnj.com ↗
Johnson & Johnson announced today a new analysis of data from the PIONEER AF-PCI clinical trial demonstrating that XARELTO®(rivaroxaban) was associated with a reduced risk of clinically significant bleeding (CSB), and net adverse clinical events (NACE; a composite of clinically significant bleeding [CSB] or major adverse cardiovascular event [MACE]) or rehospitalization compared to warfarin among both elderly and non-elderly patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), a nonsurgical procedure designed to relieve narrowing or occlusion of the coronary artery. |
| 2024-04-08 | Janssen Research & Development, LLC | Results Findings Presented at ACC.24 Showed XARELTO® (rivaroxaban) Reduced the Risk of Clinically Significant Bleeding and Net Adverse Clinical Events or Rehospitalization jnj.com ↗
Findings Presented at ACC.24 Showed XARELTO® (rivaroxaban) Reduced the Risk of Clinically Significant Bleeding and Net Adverse Clinical Events or Rehospitalization |
| 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 |
| 2024-01-23 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Rivaroxaban Tablets USP lupin.com ↗
Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) |
| 2024-01-01 | Alembic Pharmaceuticals Ltd. | Regulatory Press Release USFDA Products Approvals For the Qtr ended 31st Dec, 2023 alembicpharmaceuticals.com ↗ |
| 2023-11-14 | Janssen Research & Development, LLC | Results New VOYAGER PAD Analyses Reinforce Benefit of XARELTO® (rivaroxaban) Plus Aspirin Across High-Risk and Complex Patient Populations with Peripheral Artery Disease (PAD) jnj.com ↗
Data from the two analyses demonstrate the role of XARELTO® in treating both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD). |
| 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 |
| 2023-03-06 | Bayer | Results New real world study data on reduced risk of adverse kidney outcomes for Xarelto™ compared to VKA bayer.com ↗
In the XARENO study, Xarelto (rivaroxaban) was associated with a reduced risk of adverse kidney outcomes in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD) compared to vitamin K antagonists. |
| 2023-03-05 | Janssen Research & Development, LLC | Results New VOYAGER PAD Analysis Confirms Consistent Benefit of XARELTO® (rivaroxaban) Plus Aspirin Following Lower Extremity Revascularization (LER) jnj.com ↗
This analysis of the VOYAGER PAD study showed XARELTO®plus aspirin resulted in a 33 percent reduction in acute limb ischemia and a 15 percent reduction in major adverse limb and cardiovascular events, with or without dual antiplatelet therapy (DAPT). |
| 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. |
| 2022-06-21 | Bayer | Regulatory Rivaroxaban (Xarelto™) approved in Japan for patients with peripheral artery disease (PAD) after revascularisation bayer.com ↗
The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto™) (2.5 mg twice daily, used in combination with aspirin 81-100 mg once daily) to treat patients with peripheral artery disease (PAD) after revascularization. |
| 2022-05-23 | Janssen Research & Development, LLC | Results New Data From Two Large Studies Reinforce Effectiveness of Dual Pathway Inhibition (DPI) with XARELTO® (rivaroxaban) Plus Aspirin in Patients with Coronary Artery Disease (CAD) and/or Peripheral Artery Disease (PAD) jnj.com ↗
Separately, the XATOA registry provides real-world evidence of the benefit of DPI with the XARELTO®vascular dose in patients with CAD and/or PAD. |
| 2022-05-23 | Janssen Research & Development, LLC | Results New Data From Two Large Studies Reinforce Effectiveness of Dual Pathway Inhibition (DPI) with XARELTO® (rivaroxaban) Plus Aspirin in Patients with Coronary Artery Disease (CAD) and/or Peripheral Artery Disease (PAD) jnj.com ↗
These studies provide further evidence supporting the role of dual pathway inhibition (DPI) with the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in patients with CAD and/or PAD. |
| 2022-05-23 | Bayer | Results Two large Xarelto™ studies support effectiveness of dual pathway inhibition in patients with coronary artery disease and/or peripheral artery disease bayer.com ↗
Results from the extension part of the COMPASS study support the long-term use of Xarelto (rivaroxaban) plus aspirin for vascular protection in patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) |
| 2022-04-04 | Bayer | Results XARENO study revealed Xarelto™ was associated with net clinical benefit and a reduced risk of kidney failure compared to vitamin K antagonists bayer.com ↗ |
| 2022-04-01 | Janssen Research & Development, LLC | Results Data from New VOYAGER PAD Analyses at ACC.22 Reinforce Benefit of XARELTO® (rivaroxaban) Plus Aspirin in Patients with Peripheral Artery Disease (PAD) and Various Co-Morbid Conditions jnj.com ↗
Data from the two analyses demonstrate the role that the XARELTO®vascular dose plays in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and without a history of statin therapy. |
| 2021-12-21 | Janssen Research & Development, LLC | Regulatory FDA Approves Two New Indications for XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients jnj.com ↗
#BREAKINGNEWS: @US_FDA approves @JanssenUS therapy for the treatment and prevention of #bloodclots in #pediatric patients, providing an alternative to injectable anticoagulants that have long been the standard of care. |
| 2021-12-21 | Bayer | Regulatory U.S. FDA approves Xarelto™ to treat venous thromboembolism (VTE) and to prevent VTE in children bayer.com ↗ |
| 2021-12-20 | Janssen Research & Development, LLC | Regulatory FDA Approves Two New Indications for XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for XARELTO® (rivaroxaban): the treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged two years and older with congenital heart disease who have undergone the Fontan procedure. |
| 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). |
| 2021-09-27 | Janssen Research & Development, LLC | Results New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events jnj.com ↗
also found treatment with XARELTO®was associated with a similar safety profile compared to aspirin. |
| 2021-09-27 | Janssen Research & Development, LLC | Results New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events jnj.com ↗
New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events |
| 2021-09-27 | Bayer | Results New data for rivaroxaban in patients following the Fontan procedure and at risk for blood clots and blood clot related events bayer.com ↗
A comparable and low prevalence of bleeding events in both treatment arms was observed. |
| 2021-08-24 | Janssen Research & Development, LLC | Regulatory FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD jnj.com ↗ |
| 2021-08-24 | Janssen Research & Development, LLC | Regulatory FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. |
| 2021-08-24 | Bayer | Regulatory U.S. FDA approves expansion of the peripheral artery disease (PAD) indication for Xarelto™ plus aspirin bayer.com ↗
The U.S. Food and Drug Administration (FDA) has approved an expansion of the peripheral artery disease (PAD) indication for the Xarelto™ (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. |
| 2021-06-23 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to U.S. FDA for XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO®(rivaroxaban) in pediatric patients. |
| 2021-06-23 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to U.S. FDA for XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. |
| 2021-06-23 | Bayer | Regulatory Rivaroxaban application submitted to U.S. FDA for approval to treat VTE and to prevent VTE in children bayer.com ↗
Bayer´s development partner, Janssen Research & Development, LLC has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of the oral anticoagulant Xarelto™ (rivaroxaban) in pediatric patients. |
| 2021-05-17 | Bayer | Results Large real-world study shows benefit of rivaroxaban in patients with nonvalvular atrial fibrillation with type 2 diabetes bayer.com ↗
Real-world data presented at the American College of Cardiology's 70th Annual Scientific Session & Expo (ACC.21) showed that the oral Factor Xa inhibitor rivaroxaban (Xarelto™) was associated with reduced vascular mortality in patients with nonvalvular atrial fibrillation (NVAF) and comorbid type 2 diabetes (T2D), with fewer bleeding-related hospitalizations versus warfarin. |
| 2021-05-16 | Janssen Research & Development, LLC | Results Late-Breaking Data at ACC.21 Show XARELTO® (rivaroxaban) Plus Aspirin Significantly Reduced Total Ischemic Events in Peripheral Artery Disease (PAD) Patients After Lower-Extremity Revascularization jnj.com ↗
This analysis showed a very high burden of subsequent events and a consistent 14 percent reduction in both primary endpoint events and total vascular events over a median of 2.5 years. |
| 2021-05-16 | Janssen Research & Development, LLC | Results Late-Breaking Data at ACC.21 Show XARELTO® (rivaroxaban) Plus Aspirin Significantly Reduced Total Ischemic Events in Peripheral Artery Disease (PAD) Patients After Lower-Extremity Revascularization jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today presented new data from the Phase 3 VOYAGER PAD study which showed XARELTO ® (rivaroxaban) (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER) compared to aspirin alone regardless of whether it was the first, second, third, or subsequent event. |
| 2021-01-22 | Bayer | Regulatory Japan approves rivaroxaban (XareltoTM) to treat children with venous thromboembolism (VTE) and to prevent recurrence bayer.com ↗
The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto™) to treat VTE and prevent VTE recurrence in children, including catheter related thrombosis, cerebral vein and sinus thrombosis. |
| 2020-11-13 | Bayer | Regulatory Positive CHMP opinion for extension of rivaroxaban marketing authorization to treat venous thromboembolism (VTE) in children bayer.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a marketing authorization extension of the oral Factor Xa inhibitor, rivaroxaban (Xarelto™). |
| 2020-10-26 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO® (rivaroxaban) in Patients with Peripheral Artery Disease jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO®(rivaroxaban) in patients with peripheral artery disease (PAD). |
| 2020-10-26 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO® (rivaroxaban) in Patients with Peripheral Artery Disease jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). |
| 2020-10-26 | Bayer | Regulatory Rivaroxaban application submitted to U.S. FDA for new indication in patients after lower-extremity revascularization due to symptomatic PAD bayer.com ↗ |
| 2020-06-01 | Alembic Pharmaceuticals Ltd. | Regulatory 22nd June, 2020, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the Company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Rivaroxaban Tablets, 1 O mg, 15 mg, and 20 mg. |
| 2020-03-29 | Bayer | Results Rivaroxaban significantly reduced risk of major venous thromboembolism following nonmajor orthopaedic surgery bayer.com ↗
Bayer’s Factor Xa inhibitor, rivaroxaban (Xarelto™) reduced the risk of major venous thromboembolism (VTE) by about 75% in adult patients during a period of immobilization after nonmajor lower limb orthopaedic surgery, when compared to enoxaparin. |
| 2020-03-28 | Janssen Research & Development, LLC | Results Landmark Phase 3 VOYAGER PAD Study of XARELTO® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization jnj.com ↗
VOYAGER PAD is the only study to show a significant benefit using dual pathway inhibition, an anticoagulant plus aspirin, in this patient population. |
| 2020-03-28 | Janssen Research & Development, LLC | Results Landmark Phase 3 VOYAGER PAD Study of XARELTO® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization jnj.com ↗ |
| 2020-03-28 | Bayer | Results Xarelto™ 2.5 mg plus aspirin significantly lowered the combined risk of limb ischemia and major cardiovascular events in patients with symptomatic peripheral artery disease post revascularization bayer.com ↗
In the Phase III VOYAGER PAD study Bayer´s Factor Xa inhibitor Xarelto™ (rivaroxaban) met its primary efficacy endpoint. |
| 2019-11-25 | Bayer | Regulatory Bayer submits application to EMA for use of rivaroxaban in children with venous thromboembolism bayer.com ↗
Bayer has submitted an application to the European Medicines Agency (EMA) to extend the Xarelto marketing authorization, making it available for children up to 17 years old with confirmed VTE, including cerebral vein and sinus thrombosis. |
| 2019-10-14 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves XARELTO® (rivaroxaban) to Help Prevent Blood Clots in Acutely Ill Medical Patients jnj.com ↗
With the approval of this new indication, XARELTO®can be initiated for these patients during hospitalization and continued after discharge for a total recommended duration of 31 to 39 days. |
| 2019-10-14 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves XARELTO® (rivaroxaban) to Help Prevent Blood Clots in Acutely Ill Medical Patients jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved XARELTO® (rivaroxaban) for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding. |
| 2019-10-14 | Bayer | Regulatory U.S. FDA approves rivaroxaban to help prevent blood clots in acutely ill medical patients bayer.com ↗
Bayer AG and its development partner Janssen Research & Development, LLC announced today that the U.S. Food and Drug Administration (FDA) has approved rivaroxaban (Xarelto™) for the prevention of venous thromboembolism (VTE), or blood clots, in acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding. |
| 2019-09-20 | Janssen Research & Development, LLC | Results XARELTO® (rivaroxaban) Reduces Recurrent Blood Clots and Total Medical Costs in Morbidly Obese Patients jnj.com ↗
Notably, patients taking XARELTO®had significantly reduced healthcare resource utilization (HRU) and total medical costs compared to those taking 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 ↗
Results show Eliquis was associated with a lower rate of major bleeding and comparable rates of stroke and systemic thromboembolic events versus dabigatran or rivaroxaban |
| 2019-07-08 | Janssen Research & Development, LLC | Results XARELTO® (rivaroxaban) Helps Protect Pediatric Patients from Blood Clots in Late-Breaking Phase 3 EINSTEIN-Jr Study jnj.com ↗
These results from the largest pediatric study ever conducted for the treatment of VTE also show that the efficacy and safety profile of XARELTO®in a pediatric population with VTE is comparable to what has been observed in previous studies of adults with VTE. |
| 2019-07-08 | Bayer | Results Rivaroxaban demonstrates strong efficacy and safety profile in phase III study in children with thromboembolism bayer.com ↗
Results from the phase III EINSTEIN-Jr. study showed a strong efficacy and safety profile of rivaroxaban in children with VTE, with results similar to those seen in previous studies in adults. |
| 2019-04-29 | Bayer | Results Study reaffirms safety and efficacy profile of Xarelto™ for the prevention of stroke in patients with atrial fibrillation bayer.com ↗
The study demonstrated that in patients with atrial fibrillation and chronic kidney disease Xarelto delivered comparable effectiveness and better safety outcomes when compared to phenprocoumon. |
| 2018-12-14 | Janssen Research & Development, LLC | Regulatory Janssen Submits Supplemental New Drug Application (sNDA) to FDA for XARELTO® (rivaroxaban) to Prevent Venous Thromboembolism (VTE) in Acute Medically Ill Patients jnj.com ↗
Janssen Submits Supplemental New Drug Application (sNDA) to FDA for XARELTO® (rivaroxaban) to Prevent Venous Thromboembolism (VTE) in Acute Medically Ill Patients |
| 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 |
| 2018-10-12 | Bayer | Regulatory U.S. FDA approves Bayer’s Xarelto® for patients with coronary or peripheral artery disease bayer.com ↗
The U.S. Food and Drug Administration (FDA) has approved rivaroxaban (Xarelto®), 2.5 mg twice daily, plus aspirin low dose once daily to reduce the risk of major cardiovascular events including cardiovascular (CV) death, heart attack or stroke in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). |
| 2018-08-27 | Janssen Research & Development, LLC | Results XARELTO® (rivaroxaban) Significantly Reduced Major Cardiovascular Events in Patients with Stable Coronary and Peripheral Artery Disease in Pivotal Phase 3 Study jnj.com ↗
XARELTO® (rivaroxaban) Significantly Reduced Major Cardiovascular Events in Patients with Stable Coronary and Peripheral Artery Disease in Pivotal Phase 3 Study |
| 2018-08-27 | Janssen Research & Development, LLC | Results Janssen Announces Results from MARINER and COMMANDER HF Studies jnj.com ↗
In both studies, there was no significant difference found between XARELTO® (rivaroxaban) and placebo for the primary efficacy endpoints. |
| 2018-08-27 | Bayer | Results Results of COMMANDER HF and MARINER studies with rivaroxaban published bayer.com ↗
Study results did not show a statistical difference in primary endpoints |
| 2018-08-24 | Bayer | Regulatory Bayer secures approval in the EU for Xarelto® (rivaroxaban) for patients with coronary or peripheral artery disease bayer.com ↗ |
| 2018-07-27 | Bayer | Regulatory Bayer receives positive CHMP opinion for rivaroxaban for patients with coronary or peripheral artery disease bayer.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a new indication of Bayer´s oral Factor Xa inhibitor Xarelto® (rivaroxaban). |
| 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 |
| 2018-01-25 | Boehringer Ingelheim | Results New Real-World Analysis Finds Lower Risk of Major Bleeding and Similar Risk of Stroke with Standard Dose of Pradaxa® Compared to Rivaroxaban in NVAF Patients Newly Initiating Treatment prnewswire.com ↗ |
| 2018-01-16 | Bayer | Results FDA report reaffirms safety profile and effectiveness of Bayer’s Xarelto® in routine clinical practice bayer.com ↗
Findings from the study - part of the active drug safety surveillance of the FDA - noted that a lower risk of ischemic stroke and intercranial haemorrhage was associated with the use of rivaroxaban compared to warfarin, whilst the risk of gastrointestinal bleeding was lower with warfarin. |
| 2017-12-11 | Janssen Research & Development, LLC | Regulatory Janssen Submits Supplemental New Drug Application to FDA Seeking New Indications for XARELTO® (rivaroxaban) for Patients with Chronic Coronary and/or Peripheral Artery Disease (CAD/PAD) jnj.com ↗
Janssen Submits Supplemental New Drug Application to FDA Seeking New Indications for XARELTO® (rivaroxaban) for Patients with Chronic Coronary and/or Peripheral Artery Disease (CAD/PAD) |
| 2017-12-11 | Bayer | Regulatory Bayer’s rivaroxaban submitted to U.S. FDA for approval in patients with coronary and/or peripheral artery disease bayer.com ↗
Bayer´s development partner, Janssen Research & Development, LLC has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the rivaroxaban (Xarelto®) vascular dose, 2.5 mg twice daily, to be used in combination with low dose aspirin. |
| 2017-11-06 | Bayer | Regulatory Bayer submits application for marketing approval of rivaroxaban for patients with coronary or peripheral artery disease to European Medicines Agency bayer.com ↗
Bayer has submitted an application to the European Medicines Agency (EMA) for the marketing authorization of the vascular dose of its Factor Xa inhibitor rivaroxaban (Xarelto®) in combination with aspirin for the treatment of patients with coronary artery disease (CAD) or peripheral artery disease (PAD). |
| 2017-10-30 | Janssen Research & Development, LLC | Regulatory FDA Approves New 10 mg Dosing for XARELTO® (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE) jnj.com ↗
Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) approved the 10 mg once-daily dose of XARELTO® (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at least six months of initial anticoagulation therapy. |
| 2017-10-30 | Bayer | Regulatory Bayer receives FDA approval for Xarelto® 10 mg once daily for the extended treatment of venous thromboembolism bayer.com ↗
The FDA approval of the 10 mg dose provides physicians with an additional therapeutic option enabling them to continue the extended treatment with the regimen that best suits the benefit-risk-assessment of the individual patient. |
| 2017-10-05 | Janssen Research & Development, LLC | Results NAVIGATE ESUS Study Stopped Early Due to Comparable Efficacy in Treatment Arms jnj.com ↗
NAVIGATE ESUS Study Stopped Early Due to Comparable Efficacy in Treatment Arms |
| 2017-10-05 | Bayer | Results Bayer’s NAVIGATE ESUS study halted early as it indicated comparable efficacy between treatment arms bayer.com ↗ |
| 2017-09-15 | Bayer | Regulatory Bayer receives positive CHMP opinion for rivaroxaban 10 mg once daily for the extended prevention of venous thromboembolism bayer.com ↗
Bayer AG announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion to update the label for its oral Factor Xa inhibitor Xarelto® (rivaroxaban) to include a 10 mg once daily dose for the extended prevention of recurrent venous thromboembolism (VTE). |
| 2017-08-27 | Bayer | Results Bayer’s Xarelto® significantly lowered the combined risk of stroke, cardiovascular death and heart attack in patients with chronic coronary or peripheral artery disease by 24% bayer.com ↗
The benefit shown in the combined efficacy endpoint, major adverse cardiovascular events (MACE), for rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily was mainly driven by a significant reduction of stroke (42%) and CV death (22%). |
| 2017-07-21 | Bayer | Regulatory Xarelto in Combination with SAPT Receives Positive CHMP Opinion for Treatment of Patients with Atrial Fibrillation requiring oral Anticoagulation and undergoing PCI with Stent Placement bayer.com ↗ |
| 2017-05-01 | Janssen Research & Development, LLC | Regulatory Janssen Research & Development Submits Supplemental New Drug Application to U.S. FDA Based on EINSTEIN CHOICE Data, Which Showed Superiority with XARELTO® (rivaroxaban) Versus Aspirin in Reducing Risk of Recurrent Venous Thromboembolism (VTE), with Low Rates of Major Bleeding Across Groups jnj.com ↗
Janssen Research & Development Submits Supplemental New Drug Application to U.S. FDA |
| 2017-03-18 | Janssen Research & Development, LLC | Results New Phase 3 Study Finds XARELTO® to Be Superior to Aspirin for Long-Term Prevention of Recurrent Blood Clots Without Observing any Significant Increase in Major Bleeding in Patients with Venous Thromboembolism jnj.com ↗ |
| 2017-02-08 | Janssen Research & Development, LLC | Results Phase 3 COMPASS Study of XARELTO® (rivaroxaban) Stopping Early for Efficacy; Study Meets Primary Endpoint of Prevention of Major Adverse Cardiac Events in Patients with Coronary Artery Disease or Peripheral Artery Disease jnj.com ↗
Study Meets Primary Endpoint of Prevention of Major Adverse Cardiac Events in Patients with Coronary Artery Disease or Peripheral Artery Disease |
| 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). |
| 2015-12-07 | Janssen Research & Development, LLC | Results Real-World Data Confirms Safety and Efficacy Profile of XARELTO®, With Shorter Hospital Stays, for the Treatment of Deep Vein Thrombosis jnj.com ↗
Patients taking XARELTO® also had shorter length of hospital stays than those given standard anticoagulation. |
| 2015-09-01 | Janssen Research & Development, LLC | Results New Global Real-World Data from Atrial Fibrillation Studies Confirm the Safety Profile of XARELTO® jnj.com ↗
The results found the rates and patterns of major bleeding in routine clinical practice were low (2.89 and 2.1 per 100 person-years, respectively) and generally consistent with those observed in Phase 3 clinical research. |
| 2015-05-15 | Janssen Research & Development, LLC | Results Real-World Data Presented at American Geriatrics Society Meeting Show Consistent Safety of XARELTO® in Elderly Patients jnj.com ↗
The data show the rates of major bleeding and fatal outcomes in elderly patients treated in routine clinical practice generally are consistent with those reported in Phase 3 clinical trials, which show a correlation between increased age and bleeding. |
| 2015-05-14 | Janssen Research & Development, LLC | Results New Data on XARELTO® Versus Vitamin K Antagonists in Atrial Fibrillation Patients Undergoing Catheter Ablation Presented at Heart Rhythm 2015 jnj.com ↗ |
| 2015-03-30 | Janssen Research & Development, LLC | Results New Study Shows Reduced Hospital Admissions and Costs for Deep Vein Thrombosis Patients Treated with XARELTO® Compared to Traditional Therapy, With No Difference in Subsequent Hospital Visits jnj.com ↗
A 27 percent reduction in hospital admissions when patients were treated with XARELTO® instead of LMWH and warfarin (p<0.001). |
| 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). |
| 2015-03-02 | Janssen Research & Development, LLC | Results Findings to be Presented at Annual Scientific Session of the American College of Cardiology (ACC) About an Additional Potential Reversal Strategy for and Real-World Safety Performance of XARELTO® jnj.com ↗ |
| 2015-01-14 | Janssen Research & Development, LLC | Results Real-World Data Published in Clinical Cardiology Show Consistent Safety Performance of Once-Daily XARELTO® jnj.com ↗
Of the 27,467 patients receiving XARELTO, an incidence of major bleeding was observed at 2.86 per 100 person-years, which was generally consistent with rates reported in the ROCKET-AF clinical trial. |
| 2014-11-18 | Janssen Research & Development, LLC | Results Real-World Data Presented at the American Heart Association (AHA) Scientific Sessions Underscore Hospitalization and Outpatient Cost-Savings for XARELTO® Compared to Standard of Care jnj.com ↗
New data presented today at the American Heart Association (AHA) 2014 Scientific Sessions showed once-daily XARELTO® (rivaroxaban) is associated with significantly fewer hospitalization days and outpatient visits compared to warfarin in patients with non-valvular atrial fibrillation (NVAF). |
| 2014-09-02 | Janssen Research & Development, LLC | Results New Data Show Once-Daily XARELTO® May Be an Alternative to Vitamin K Antagonists in Treating Atrial Fibrillation Patients Undergoing Elective Cardioversion jnj.com ↗
In addition, 0.61 percent of patients treated with XARELTO® were also observed to have a major bleeding event compared with 0.81 percent for VKA. |
| 2014-01-16 | Janssen Research & Development, LLC | Regulatory FDA Advisory Committee Recommends Against Approval of the Use of Oral Anticoagulant XARELTO® to Reduce the Risk of Thrombotic Cardiovascular Events in Patients with Acute Coronary Syndrome jnj.com ↗
FDA Advisory Committee Recommends Against Approval of the Use of Oral Anticoagulant XARELTO® to Reduce the Risk of Thrombotic Cardiovascular Events in Patients with Acute Coronary Syndrome |
| 2013-09-20 | Janssen Research & Development, LLC | Results Pooled Analysis Confirms XARELTO® has Similar Efficacy and Reduces the Incidence of Major Bleeding by Nearly Half Compared to Standard of Care in Treatment of DVT and PE jnj.com ↗ |
| 2013-06-28 | Janssen Research & Development, LLC | Regulatory FDA Issues Complete Response Letter for XARELTO® (rivaroxaban) to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome jnj.com ↗
FDA Issues Complete Response Letter for XARELTO ® (rivaroxaban) to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome |
| 2013-03-04 | Janssen Research & Development, LLC | Regulatory FDA Issues Complete Response Letter for XARELTO® (rivaroxaban) for the Reduction of Cardiovascular Events in Patients with Acute Coronary Syndrome jnj.com ↗ |
| 2012-06-05 | BioInvent International AB | Results BioInvent and ThromboGenics Announce Results from Phase IIb Venous Thromboembolism Prevention Study with TB-402 bioinvent.com ↗
The study showed that the incidence of venous thromboembolism (VTE) was similar with both drugs but patients receiving TB-402 had a significantly higher incidence of bleeding events. |
All press releases naming this drug 116 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 116 releases opens the full record — a long page | ||
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 397 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RIVAROXABAN | “AF patients with a CHA2DS2-VASc score >2 and no previous history of overt coronary disease, severe peripheral arterial disease (PAD) or major stroke will be registered and...” PMID 27558002 ↗ Aug 2016392“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 ↗ “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 ↗ “Century Clot-guided rivaroxaban prophylactic therapy (2.5 mg twice daily, if the hypercoagulable state, defined as CR ≥24) in combination with standard DAPT could reduce LVT...” NCT06013020 ↗ “For patients with creatinine clearance ≥50 ml/min, oral rivaroxaban 20 mg daily was administered, whereas for patients with creatinine clearance between 30-49 ml/min, oral...” NCT06021808 ↗ “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 ↗ “The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month...” NCT03804697 ↗ “Patients will be treated with warfarin with dose adjusted to goal International Normalized Ratio (INR) of 2-3 or rivaroxaban standard dose (15 mg twice daily for 3 weeks then...” NCT02331095 ↗ “Non-vitamin K antagonist oral anticoagulant therapy (e.g., apixaban, rivaroxaban, dabigatran, or edoxaban) administered according to approved labeling and guideline-recommended dosing.” NCT07497893 ↗ |
| Known as | BAY59-7939 | “Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism” NCT00403767 ↗42“One promising therapeutic option is rivaroxaban (BAY 59-7939, Rivaroxaban), an orally administered direct factor Xa inhibitor” NCT02438098 ↗ “Two Strategies of Rivaroxaban [JNJ39039039; BAY-59-7939] and One of Oral Vitamin K Antagonist” NCT01830543 ↗ “Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.” NCT00362232 ↗ “Drug: Xarelto (Rivaroxaban, BAY59-7939)” NCT00973245 ↗ “Drug: Rivaroxaban (Xarelto, BAY59-7939)” NCT02504216 ↗ “Drug: Rivaroxaban (Xarelto, BAY59-7939)” NCT01853800 ↗ “Drug: Rivaroxaban (Xarelto, BAY59-7939)” NCT01507051 ↗ “Drug: Rivaroxaban (Xarelto, BAY59-7939)” NCT01442792 ↗ “Rivaroxaban (Xarelto, BAY59-7939)” NCT00439777 ↗ “Rivaroxaban (Xarelto, BAY59-7939)” NCT02309411 ↗ |
| Known as | JNJ39039039 | “Two Strategies of Rivaroxaban [JNJ39039039; BAY-59-7939] and One of Oral Vitamin K Antagonist” NCT01830543 ↗ |
| Known as | Rivaroxaban (Xarelto) | “Rivaroxaban (Xarelto)” NCT07011095 ↗ |
| Known as | Rivaroxaban accord | ChEMBL registry synonym — accepted as the source's own label CHEMBL198362 ↗ |
| Known as | Rivaroxaban viatris (previously rivaroxaban mylan) | ChEMBL registry synonym — accepted as the source's own label CHEMBL198362 ↗ |
| Known as | Rivaroxabana | “Xarelto 15 mg Rivaroxabana 15 mg” NCT05515120 ↗ |
| Known as | Rovaltro | “Rivaroxaban (Rovaltro®) is a novel oral anticoagulant” NCT04569279 ↗ |
| Known as | Xarelto | “Thromboprophylactic regimens Aspirin®(acetylsalicylic acid, AA, Bayer) 300mg/day or Xarelto® (rivaroxaban, factor Xa-inhibitor, Bayer) 10mg/day will be randomly(according to...” NCT02271399 ↗48“Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)” NCT04684212 ↗ “A Randomized, Controlled, Phase 2b Study to Evaluate Safety and Efficacy of Rivaroxaban (Xarelto®) for High Risk People With Mild COVID-19” NCT04504032 ↗ “Blood concentrations of rivaroxaban (Xarelto, Titusville, New Jersey) at 4 weeks were undetectable in 21% patients from Eastern Europe” PMID 33549557 ↗ Feb 2021 “Single administration of oral rivaroxaban in the form of Xarelto® 10mg tablets (Bayer Schering Pharma, Berlin, Germany).” NCT02970773 ↗ “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 ↗ “Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.” NCT00362232 ↗ “a new blood thinner called rivaroxaban (Xarelto) can be used to treat HIT” NCT01598168 ↗ “Drug: Rivaroxaban (Xarelto, BAY59-7939)” NCT01442792 ↗ |
| Known as | Xarelto is the brand name for rivaroxaban | “Xarelto is the brand name for rivaroxaban” NCT01478282 ↗ |
| Action | Inhibit | “an oral direct inhibitor of factor Xa” PMID 18579811 ↗ Jun 2008 |
| Modality | Other / unclassified | “direct oral anticoagulant” NCT04794569 ↗ |
| Route | Oral | “10 mg of oral rivaroxaban once daily” PMID 18579811 ↗ Jun 2008 |
| Target | F10 | “the direct factor Xa inhibitor rivaroxaban” NCT01812200 ↗ |