Xarelto(rivaroxaban)
Rivaroxaban, Xarelto (rivaroxaban) is a small molecule pharmaceutical. Rivaroxaban was first approved as Xarelto on 2008-09-30. It is used to treat pulmonary embolism and venous thrombosis in the USA. It has been approved in Europe to treat acute coronary syndrome, atrial fibrillation, coronary artery disease, peripheral arterial disease, and pulmonary embolism amongst others. The pharmaceutical is active against coagulation factor X.
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Commercial
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Xarelto
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rivaroxaban
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XARELTO | Johnson & Johnson | N-022406 RX | 2011-07-01 | 4 products, RLD |
| XARELTO | Johnson & Johnson | N-215859 RX | 2021-12-20 | 1 products, RLD, RS |
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pulmonary embolism | EFO_0003827 | D011655 | I26 |
| venous thrombosis | HP_0004936 | D020246 | I82.40 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
RIVAROXABAN, XARELTO, JANSSEN PHARMS | |||
| 2025-06-20 | PED | ||
| 2025-02-23 | PED | ||
| 2024-12-20 | NP | ||
| 2024-08-23 | I-867 | ||
| 2023-09-10 | PED | ||
| 2023-04-11 | PED | ||
| 2023-03-10 | M-284 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Rivaroxaban, Xarelto, Janssen Pharms | |||
| 10828310 | 2039-01-31 | U-3207, U-3208 | |
| 9539218 | 2034-02-17 | U-1953, U-1954, U-1955, U-1957, U-2143, U-2641, U-3285, U-3288, U-3289 | |
| 9415053 | 2024-11-13 | DP | U-1167, U-1200, U-1301, U-1302, U-2142, U-2435, U-2640, U-3205, U-3206, U-3284, U-3286, U-3287 |
| 7157456 | 2024-08-28 | DS, DP | U-1301, U-1302 |
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Clinical
Clinical Trials
602 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | 2 | 7 | 17 | 33 | 99 | 157 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | 3 | 11 | 26 | 7 | 34 | 78 |
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | 2 | 6 | 10 | 10 | 25 | 51 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 4 | 9 | 11 | 17 | 39 |
| Pulmonary embolism | D011655 | HP_0002204 | I26 | — | 1 | 5 | 6 | 22 | 33 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | 3 | 7 | 5 | 8 | 23 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | 3 | 2 | 7 | 10 | 22 |
| Coronary artery disease | D003324 | — | I25.1 | — | 2 | 2 | 10 | 6 | 20 |
| Ischemic stroke | D000083242 | — | — | — | 4 | 4 | 1 | 11 | 18 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | 7 | 2 | 6 | 16 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 13 | 4 | 1 | — | 2 | 19 |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | — | 2 | — | 3 | 5 |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | 2 | 2 | — | 2 | 5 |
| Intracranial thrombosis | D020767 | — | — | 1 | 2 | 1 | — | 1 | 4 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 2 | 1 | 1 | — | 1 | 4 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | 1 | — | 1 | 3 |
| Rheumatic heart disease | D012214 | EFO_1001161 | I09.9 | — | — | 3 | — | — | 3 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | 1 | — | 1 | 2 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | 1 | — | 1 | 2 |
| Cerebral hemorrhage | D002543 | — | — | — | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | 2 | 3 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | 1 | — | — | — | 2 |
| Transient ischemic attack | D002546 | EFO_0003764 | G45.9 | — | 1 | — | — | 1 | 2 |
| Brain ischemia | D002545 | EFO_0003883 | I67.82 | — | 1 | — | — | 1 | 2 |
| Bariatric surgery | D050110 | — | — | 1 | 1 | — | — | — | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 1 | — | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | 1 | — | — | — | 1 |
| Duodenal neoplasms | D004379 | — | — | — | 1 | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | — | — | — | 1 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 4 | — | — | — | — | 4 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | 1 | 3 |
| Biological availability | D001682 | — | — | 2 | — | — | — | — | 2 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | — | — | — | — | 1 |
| Coagulation protein disorders | D020147 | — | — | 1 | — | — | — | — | 1 |
| Immune system diseases | D007154 | — | D89.9 | 1 | — | — | — | — | 1 |
| Immunotherapy | D007167 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombophilia | D019851 | — | D68.59 | — | — | — | — | 2 | 2 |
| Replacement arthroplasty knee | D019645 | — | — | — | — | — | — | 2 | 2 |
| Replacement arthroplasty hip | D019644 | — | — | — | — | — | — | 2 | 2 |
| Patient satisfaction | D017060 | — | — | — | — | — | — | 1 | 1 |
| Patient participation | D010358 | — | — | — | — | — | — | 1 | 1 |
| Oral surgery | D013515 | — | — | — | — | — | — | 1 | 1 |
| Postoperative complications | D011183 | — | — | — | — | — | — | 1 | 1 |
| Oral surgical procedures | D019647 | — | — | — | — | — | — | 1 | 1 |
| Postoperative hemorrhage | D019106 | — | — | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
Show 26 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Rivaroxaban |
| INN | rivaroxaban |
| Description | Rivaroxaban is a monocarboxylic acid amide obtained by formal condensation of the carboxy group of 5-chlorothiophene-2-carboxylic acid with the amino group of 4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one. It is an anticoagulant used for prophylaxis of venous thromboembolism in patients with knee or hip replacement surgery. It has a role as an anticoagulant and an EC 3.4.21.6 (coagulation factor Xa) inhibitor. It is a member of thiophenes, an organochlorine compound, an oxazolidinone, a member of morpholines, a lactam, an aromatic amide and a monocarboxylic acid amide. Rivaroxaban is an orally bioavailable oxazolidinone derivative and direct inhibitor of the coagulation factor Xa with anticoagulant activity. 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. |
| Classification | Small molecule |
| Drug class | antithrombotics, blood coagulation factor XA inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1 |
Identifiers
| PDB | — |
| CAS-ID | 366789-02-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL198362 |
| ChEBI ID | 68579 |
| PubChem CID | 9875401 |
| DrugBank | DB06228 |
| UNII ID | 9NDF7JZ4M3 (ChemIDplus, GSRS) |
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Xarelto – Johnson & Johnson
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Rivaroxaban
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Safety
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132,140 adverse events reported
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