Savaysa, Lixiana(edoxaban)
Lixiana, Roteas, Savaysa (edoxaban) is a small molecule pharmaceutical. Edoxaban was first approved as Savaysa on 2015-01-08. It is used to treat pulmonary embolism and venous thrombosis in the USA. It has been approved in Europe to treat stroke and venous thromboembolism. The pharmaceutical is active against coagulation factor X.
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Commercial
Trade Name
FDA
EMA
Savaysa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Edoxaban tosylate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
SAVAYSA | Daiichi Pharmaceutical | N-206316 RX | 2015-01-08 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
savaysa | New Drug Application | 2021-03-11 |
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
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HCPCS
No data
Clinical
Clinical Trials
108 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 | — | 5 | 8 | 8 | 20 | 41 |
Venous thrombosis | D020246 | HP_0004936 | I82.40 | 1 | 3 | 3 | 2 | 2 | 11 |
Stroke | D020521 | EFO_0000712 | I63.9 | — | 3 | 2 | 2 | 1 | 7 |
Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | — | 3 | 1 | 2 | 6 |
Hemorrhage | D006470 | MP_0001914 | R58 | 2 | 1 | — | 1 | 1 | 5 |
Neoplasms | D009369 | C80 | — | — | 1 | 2 | 2 | 5 | |
Ischemic stroke | D000083242 | — | 1 | 1 | 1 | 2 | 5 | ||
Thrombosis | D013927 | — | 3 | — | 1 | 1 | 5 | ||
Thromboembolism | D013923 | HP_0001907 | — | 2 | 1 | 1 | — | 4 | |
Coronary artery disease | D003324 | I25.1 | — | — | — | 2 | 1 | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Venous thromboembolism | D054556 | EFO_0004286 | I74 | 1 | 2 | 7 | — | 6 | 16 |
Embolism | D004617 | — | — | 1 | — | 1 | 2 | ||
Covid-19 | D000086382 | U07.1 | — | — | 2 | — | — | 2 | |
Aortic valve stenosis | D001024 | EFO_0000266 | Q25.1 | — | — | 2 | — | — | 2 |
Cerebral hemorrhage | D002543 | — | — | 1 | — | — | 1 | ||
Hypertensive intracranial hemorrhage | D020299 | — | — | 1 | — | — | 1 | ||
Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | 1 | — | — | 1 |
Subdural hematoma | D006408 | HP_0100309 | — | — | 1 | — | — | 1 | |
Cerebral intraventricular hemorrhage | D000074042 | — | — | 1 | — | — | 1 | ||
Atrial flutter | D001282 | EFO_0003911 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 2 | 1 | — | — | 1 | 4 | ||
Replacement arthroplasty hip | D019644 | — | 2 | — | — | — | 2 | ||
Peripheral arterial disease | D058729 | EFO_0004265 | — | 1 | — | — | — | 1 | |
Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
Inflammation | D007249 | — | 1 | — | — | — | 1 | ||
Embolism and thrombosis | D016769 | — | 1 | — | — | — | 1 | ||
Replacement arthroplasty knee | D019645 | — | 1 | — | — | — | 1 | ||
Mitral valve stenosis | D008946 | EFO_0007372 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Coagulation protein disorders | D020147 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Oral surgery | D013515 | — | — | — | — | 1 | 1 | ||
Postoperative complications | D011183 | — | — | — | — | 1 | 1 | ||
Oral surgical procedures | D019647 | — | — | — | — | 1 | 1 | ||
Menorrhagia | D008595 | N92.0 | — | — | — | — | 1 | 1 | |
Intracranial arteriosclerosis | D002537 | EFO_1000860 | I67.2 | — | — | — | — | 1 | 1 |
Heart valve diseases | D006349 | EFO_0009551 | I08 | — | — | — | — | 1 | 1 |
Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
Frailty | D000073496 | R53.1 | — | — | — | — | 1 | 1 | |
Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | EDOXABAN |
INN | edoxaban |
Description | Edoxaban is a monocarboxylic acid amide that is used (as its tosylate monohydrate) for the treatment of deep vein thrombosis and pulmonary embolism. It has a role as an anticoagulant, an EC 3.4.21.6 (coagulation factor Xa) inhibitor and a platelet aggregation inhibitor. It is a monocarboxylic acid amide, a chloropyridine, a thiazolopyridine and a tertiary amino compound. It is a conjugate base of an edoxaban(1+). |
Classification | Small molecule |
Drug class | antithrombotics, blood coagulation factor XA inhibitors |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CN1CCc2nc(C(=O)N[C@@H]3C[C@@H](C(=O)N(C)C)CC[C@@H]3NC(=O)C(=O)Nc3ccc(Cl)cn3)sc2C1 |
Identifiers
PDB | — |
CAS-ID | 480449-70-5 |
RxCUI | 1599538 |
ChEMBL ID | CHEMBL1269025 |
ChEBI ID | 85973 |
PubChem CID | 10280735 |
DrugBank | DB09075 |
UNII ID | NDU3J18APO (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 6,130 documents
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Safety
Black-box Warning
Black-box warning for: Savaysa
Adverse Events
Top Adverse Reactions
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10 adverse events reported
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