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Xarelto(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
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
nervous system diseasesD009422
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
operative surgical proceduresD013514
Trade Name
FDA
EMA
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
XARELTOJohnson & JohnsonN-022406 RX2011-07-01
4 products, RLD
XARELTOJohnson & JohnsonN-215859 RX2021-12-20
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
xareltoNew Drug Application2023-02-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary embolismEFO_0003827D011655I26
venous thrombosisHP_0004936D020246I82.40
Agency Specific
FDA
EMA
Expiration
Code
RIVAROXABAN, XARELTO, JANSSEN PHARMS
2025-06-20PED
2025-02-23PED
2024-12-20NP
2024-08-23I-867
2023-09-10PED
2023-04-11PED
2023-03-10M-284
Patent Expiration
Patent
Expires
Flag
FDA Information
Rivaroxaban, Xarelto, Janssen Pharms
108283102039-01-31U-3207, U-3208
95392182034-02-17U-1953, U-1954, U-1955, U-1957, U-2143, U-2641, U-3285, U-3288, U-3289
94150532024-11-13DPU-1167, U-1200, U-1301, U-1302, U-2142, U-2435, U-2640, U-3205, U-3206, U-3284, U-3286, U-3287
71574562024-08-28DS, DPU-1301, U-1302
ATC Codes
B: Blood and blood forming organ drugs
B01: Antithrombotic agents
B01A: Antithrombotic agents
B01AF: Direct factor xa inhibitors
B01AF01: Rivaroxaban
HCPCS
No data
Clinical
Clinical Trials
399 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atrial fibrillationD001281EFO_0000275I48.02513215191
Venous thromboembolismD054556EFO_0004286I742102372161
Venous thrombosisD020246HP_0004936I82.4024991538
Pulmonary embolismD011655EFO_0003827I261461323
StrokeD020521EFO_0000712I63.9486621
Acute coronary syndromeD054058EFO_0005672327416
ThrombosisD0139273134414
HemorrhageD006470MP_0001914R581325313
NeoplasmsD009369C801171312
Peripheral arterial diseaseD058729EFO_0004265215412
Show 41 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ischemic strokeD0000832424539
Liver cirrhosisD008103EFO_0001422K74.021114
Renal insufficiencyD051437HP_0000083N191113
Heart valve diseasesD006349EFO_0009551I08223
Rheumatic heart diseaseD012214EFO_1001161I09.933
Intracranial thrombosisD0207671213
Intracranial hemorrhagesD020300EFO_0000551I62112
May-thurner syndromeD062108112
Brain ischemiaD002545I67.821112
Sickle cell anemiaD000755EFO_0000697D57112
Show 27 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients132116
Bariatric surgeryD050110112
Pancreatic neoplasmsD010190EFO_0003860C2511
Stomach neoplasmsD013274EFO_0003897C1611
Esophageal neoplasmsD004938C1511
Duodenal neoplasmsD00437911
Liver neoplasmsD008113EFO_1001513C22.011
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A11
Biliary tract neoplasmsD001661C24.911
Ampulla of vater cancer11
Show 4 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD01381044
PharmacokineticsD01059922
Biological availabilityD00168222
Morbid obesityD009767EFO_000107411
Coagulation protein disordersD02014711
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Replacement arthroplasty kneeD01964522
Replacement arthroplasty hipD01964422
ThrombophiliaD019851D68.5911
Oral surgeryD01351511
Postoperative complicationsD01118311
Oral surgical proceduresD01964711
MenorrhagiaD008595N92.011
Periodontal diseasesD010510K05.611
Pituitary acth hypersecretionD047748EFO_1001110E24.011
FrailtyD000073496R53.111
Show 4 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRIVAROXABAN
INNrivaroxaban
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 classantithrombotics, 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
PDB2W26
CAS-ID366789-02-8
RxCUI1114195
ChEMBL IDCHEMBL198362
ChEBI ID68579
PubChem CID9875401
DrugBankDB06228
UNII ID9NDF7JZ4M3 (ChemIDplus, GSRS)
Target
Agency Approved
F10
F10
Organism
Homo sapiens
Gene name
F10
Gene synonyms
NCBI Gene ID
Protein name
coagulation factor X
Protein synonyms
factor X, factor Xa, prothrombinase, Stuart factor, Stuart-Prower factor
Uniprot ID
Mouse ortholog
F10 (14058)
coagulation factor X (Q99L32)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Xarelto - Johnson & Johnson
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 17,190 documents
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Safety
Black-box Warning
Black-box warning for: Xarelto
Adverse Events
Top Adverse Reactions
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138,519 adverse events reported
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