Rivaroxaban clinical trials
Rivaroxaban is named as an intervention in 51 current clinical trials in our China, Canada, France, Denmark, South Korea, Germany, Italy, Sweden, Switzerland, USA, Poland, Spain, Netherlands, Brazil, Australia, Mexico, Israel, UK, Czechia, Taiwan, India, Austria, Norway, Belgium, Turkey, Japan and Egypt registers. 39 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Ottawa Hospital Research Institute (4). The most-studied condition is Atrial Fibrillation. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Rivaroxaban is approved
All regulators →Of the three regulators tracked here, the first to approve Rivaroxaban was Canada, on 15 Sep 2008. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Rivaroxaban patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Rivaroxaban, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 1 listed patent; the last listed expires 17 Aug 2034 (US 9539218, including a 6-month paediatric extension).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Rivaroxaban
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Rivaroxaban works
All drug targets →- Coagulation factor X inhibitor InhibitorTarget: F10 coagulation factor X✓ In ChEMBL and the Guide to Pharmacology
- Behcet diseasePhase 3
- Portal vein thrombosisPhase 3
- ST Elevation Myocardial InfarctionPhase 3
- ThrombocytopeniaPhase 3
- ThromboembolismPhase 3
- Aortic stenosisPhase 3
- Autoimmune polyendocrinopathyPhase 3
- Cardiovascular disorderPhase 3
- HemorrhagePhase 3
- Mitral valve stenosisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL198362, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6388, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Rivaroxaban
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Rivaroxaban. 5 are current, and 5 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome NICE TA335 | Recommended | 25 Mar 2015 | Current |
| Rivaroxaban for treating pulmonary embolism and preventing recurrent venous thromboembolism NICE TA287 | Recommended | 26 Jun 2013 | Current |
| Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism NICE TA261 | Recommended | 25 Jul 2012 | Current |
| Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation NICE TA256 | Recommended | 23 May 2012 Updated 2 Jul 2021 | Current |
| Rivaroxaban for preventing venous thromboembolism after hip or knee replacement surgery NICE TA170 | Recommended | 22 Apr 2009 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Rivaroxaban
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 65 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Xarelto, Rivaroxaban Accord (generic), Rivaroxaban Viatris (previously Rivaroxaban Mylan) (generic), Svariya (previously Rivaroxaban Koanaa) (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Rivaroxaban
- ATC code
- B01AF01
- ChEMBL
- CHEMBL198362
- DrugBank
- DB06228
- PubChem CID
- 9875401
- CAS number
- 366789-02-8
- FDA UNII
- 9NDF7JZ4M3
- Wikidata
- Q420262
- Wikipedia
- Rivaroxaban
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Rivaroxaban
51 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Rivaroxaban in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Rivaroxaban. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants with Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)
2025-522954-37-00 · Hemic and Lymphatic Diseases
|
Phase 3 | Authorised | Regeneron Pharmaceuticals Inc | Spain, Slovakia, Hungary + 16 more |
|
Pulmonary Embolism & Anticoagulation Evaluation in Cancer Patient - PEACE
2025-524110-28-00 · CTIS ↗ · Cardiovascular Diseases
|
Phase 4 | Authorised | Region Hovedstaden | Denmark |
Rivaroxaban across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
65 single-substance products containing Rivaroxaban on the HPRA medicines list.
- Rivaroxaban Clonmel 15 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/035/003 · Marketed
- Rivaroxaban Clonmel 20 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/035/004 · Marketed
- Rivaroxaban Krka 10 mg film-coated tabletsKRKA, d.d., Novo mesto · PA1347/098/002 · Marketed
- Rivaroxaban Krka 15 mg film-coated tabletsKRKA, d.d., Novo mesto · PA1347/098/003 · Marketed
- Rivaroxaban Krka 20 mg film-coated tabletsKRKA, d.d., Novo mesto · PA1347/098/004 · Marketed
Supply shortages
- Rivaroxaban For SuspensionUS (FDA) · Resolved · updated 18 Sep 2026
- Xarelto 1 mg/ml Granulat zur Herstellung einer Suspension zum EinnehmenGermany (BfArM) · Other reason · 15 Jun 2026 to 31 Dec 2028
- Xarelto 1 mg/ml Granulat zur Herstellung einer Suspension zum EinnehmenGermany (BfArM) · Other reason · 24 Sep 2026 to 30 Nov 2026
Recent approvals
- Svariya (previously Rivaroxaban Koanaa)EMA · 21 Nov 2025 · generic · PGF Pharma International d.o.o.
Conditions studied with Rivaroxaban
88 conditionsAll 88 conditions
| Condition (as registered) | Trials |
|---|---|
| Atrial Fibrillation | 10 |
| Stroke | 6 |
| Venous Thromboembolism | 6 |
| Pulmonary Embolism | 5 |
| Deep Vein Thrombosis | 3 |
| Anticoagulant Adverse Reaction | 2 |
| Kawasaki Disease | 2 |
| Coronary Artery Aneurysm | 2 |
| Percutaneous Coronary Intervention | 2 |
| Multiple Myeloma | 2 |
| Venous Thromboembolism (VTE) | 2 |
| Ischemic Stroke | 2 |
| Prevention of Venous Thromboembolism | 2 |
| Thrombosis | 2 |
| Cardiovascular Diseases | 2 |
| Peripheral Artery Disease (PAD) | 1 |
| Atrial Fibrillation (AF) | 1 |
| Portal Vein Thrombosis | 1 |
| Anticoagulant Therapy | 1 |
| Variceal Bleeding | 1 |
| Idiopathic Membranous Nephropathy | 1 |
| Major Adverse Cardiac Events | 1 |
| ST-segment Elevation Myocardial Infarction (STEMI) | 1 |
| Left Ventricular Thrombus | 1 |
| Pilot Study | 1 |
| Rivaroxaban | 1 |
| Coronary Artery Disease | 1 |
| Acute Coronary Syndrome | 1 |
| Large-Artery Atherosclerosis (Embolus/Thrombosis) | 1 |
| Iliac Vein Thrombosis | 1 |
| Iliac Vein Obstruction | 1 |
| Iliac Vein Stenosis | 1 |
| Bleeding Post Cardiac Surgery | 1 |
| Indication for Anticoagulation | 1 |
| Hip Arthroplasty, Total | 1 |
| Children Under 2 Years | 1 |
| Antiphospholipid Syndrome | 1 |
| Anticoagulants Causing Adverse Effects in Therapeutic Use | 1 |
| Embolism | 1 |
| Embolism and Thrombosis | 1 |
| Lung Diseases | 1 |
| Behcet Syndrome | 1 |
| Cerebral Infarction | 1 |
| Lower Limb Trauma | 1 |
| Chronic Hemodialysis Patients | 1 |
| Intracardiac Thrombus | 1 |
| Hip Fracture Surgery | 1 |
| Cardiovascular Prevention | 1 |
| Aortic Valve Stenosis | 1 |
| Heart Diseases | 1 |
| Heart Valve Diseases | 1 |
| Atrial Flutter | 1 |
| Lymphoma | 1 |
| Leukemia | 1 |
| Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma | 1 |
| Venous Thromboembolic Disease | 1 |
| Liver Cirrhosis | 1 |
| Behcet Disease | 1 |
| Behcet Disease and Vascular Involvement | 1 |
| Deep Venous Thromboses | 1 |
| Post Thrombotic Syndrome | 1 |
| Staphylococcus Aureus Endocarditis | 1 |
| Staphylococcus Aureus Septicemia | 1 |
| Staphylococcus Aureus Bacteremia | 1 |
| Staphylococcus Aureus Bloodstream Infection | 1 |
| Cancer | 1 |
| Urologic Cancer | 1 |
| Hip Fractures | 1 |
| SVT | 1 |
| Superficial Vein Thrombosis | 1 |
| Peripheral Arterial Disease | 1 |
| Venous Thormboembolism | 1 |
| Vascular Surgery Patient with PAD / Carotid Stenosis | 1 |
| Intracranial Arteriosclerosis | 1 |
| Coronary Artery Ectasia | 1 |
| Acute Coronary Syndromes (ACS) | 1 |
| STEMI - ST Elevation Myocardial Infarction | 1 |
| NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI) | 1 |
| Congenital Heart Disease | 1 |
| Fontan Procedure | 1 |
| Children | 1 |
| AORTIC VALVE DISEASES | 1 |
| Thromboembolism | 1 |
| Postpartum Period | 1 |
| Cesarean Section Surgery | 1 |
| VTE (Venous Thromboembolism) | 1 |
| Morbid Obesity | 1 |
| Bariatric Surgery Candidate | 1 |
Sponsors
lead sponsor per trial+ 26 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Rivaroxaban trials
How many clinical trials are testing Rivaroxaban?
51 current trials in our China, Canada, France, Denmark, South Korea, Germany, Italy, Sweden, Switzerland, USA, Poland, Spain, Netherlands, Brazil, Australia, Mexico, Israel, UK, Czechia, Taiwan, India, Austria, Norway, Belgium, Turkey, Japan and Egypt registers name Rivaroxaban (also registered as Xarelto, BAY59-7939) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Rivaroxaban trials recruiting patients?
Yes. 39 of the 51 trials are recruiting: 12 with sites in China, 9 with sites in Canada, 6 with sites in France, 2 with sites in Denmark, 4 with sites in South Korea, 4 with sites in Germany, 2 with sites in Italy, 2 with sites in Sweden, 3 with sites in Switzerland, 1 with sites in USA, 1 with sites in Poland, 1 with sites in Spain, 2 with sites in Netherlands, 2 with sites in Brazil, 2 with sites in Australia, 1 with sites in Mexico, 1 with sites in Israel, 1 with sites in UK, 1 with sites in India, 1 with sites in Austria, 1 with sites in Norway, 1 with sites in Belgium and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Rivaroxaban clinical trials?
Ottawa Hospital Research Institute (4), Population Health Research Institute (2), China National Center for Cardiovascular Diseases (2) and Children's Hospital of Fudan University (2), among 41 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Rivaroxaban licensed in Ireland?
Yes. The HPRA medicines list includes 65 single-substance products containing Rivaroxaban, for example Rivaroxaban Clonmel 15 mg film-coated tablets (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Rivaroxaban shortage?
The registers we track list 3 entries for Rivaroxaban: US FDA: resolved; 2 German notices. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Rivaroxaban works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Rivaroxaban works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Rivaroxaban (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.