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
Therapeutic Areas
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 | 2024-02-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| venous thrombosis | — | D020246 | I82.40 |
| pulmonary embolism | EFO_0003827 | D011655 | I26 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
EDOXABAN TOSYLATE, SAVAYSA, DAIICHI SANKYO INC | |||
| 2026-10-18 | M-14 | ||
HCPCS
No data
Clinical
Clinical Trials
190 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 | — | 3 | 6 | 4 | 10 | 23 |
| Thrombosis | D013927 | — | — | 1 | 5 | 3 | 1 | — | 10 |
| Embolism | D004617 | — | — | — | 1 | 4 | 1 | — | 6 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | 2 | 1 | 1 | 5 |
| Coronary artery disease | D003324 | — | I25.1 | — | 1 | 1 | 3 | — | 4 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | — | — | 1 | — | 2 |
| Coronary disease | D003327 | — | — | — | — | — | 2 | — | 2 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | 2 | — | 2 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | 1 | — | 1 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thromboembolism | D013923 | — | — | 1 | 3 | 7 | — | 3 | 14 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | 1 | 2 | 7 | — | 3 | 13 |
| Venous thrombosis | D020246 | — | I82.40 | 1 | 3 | 3 | — | — | 7 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | — | 3 | — | — | 3 |
| Ischemic stroke | D000083242 | — | — | — | — | 1 | — | 1 | 2 |
| Renal insufficiency | D051437 | — | N19 | — | — | 2 | — | — | 2 |
| Aortic valve stenosis | D001024 | EFO_0000266 | — | — | — | 1 | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 1 | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | — | 1 | — | — | 1 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Replacement arthroplasty hip | D019644 | — | — | — | 2 | — | — | — | 2 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | 1 | — | — | — | 1 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | 1 | — | — | — | 1 |
| Embolism and thrombosis | D016769 | — | — | — | 1 | — | — | — | 1 |
| Replacement arthroplasty knee | D019645 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemia | D007511 | EFO_0000556 | — | — | — | — | — | 1 | 1 |
| Cerebral infarction | D002544 | — | I63 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 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 | — |
| ChEMBL ID | CHEMBL1269025 |
| ChEBI ID | 85973 |
| PubChem CID | 10280735 |
| DrugBank | DB09075 |
| UNII ID | NDU3J18APO (ChemIDplus, GSRS) |
Target
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Safety
Black-box Warning
Black-box warning for: Savaysa
Adverse Events
Top Adverse Reactions
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8,276 adverse events reported
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