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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
Therapeutic Area
MeSH
respiratory tract diseasesD012140
nervous system diseasesD009422
cardiovascular diseasesD002318
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
SAVAYSADaiichi PharmaceuticalN-206316 RX2015-01-08
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
savaysaNew Drug Application2021-03-11
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary embolismEFO_0003827D011655I26
venous thrombosisHP_0004936D020246I82.40
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Edoxaban Tosylate, Savaysa, Daiichi Sankyo Inc
91495322028-03-28DP
73652052027-04-18DP
ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AF: Direct factor xa inhibitors
— B01AF03: Edoxaban
HCPCS
No data
Clinical
Clinical Trials
108 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_0000275I48.0—5882041
Venous thrombosisD020246HP_0004936I82.401332211
StrokeD020521EFO_0000712I63.9—32217
Pulmonary embolismD011655EFO_0003827I26——3126
HemorrhageD006470MP_0001914R5821—115
NeoplasmsD009369C80——1225
Ischemic strokeD000083242—11125
ThrombosisD013927—3—115
ThromboembolismD013923HP_0001907—211—4
Coronary artery diseaseD003324I25.1———213
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Venous thromboembolismD054556EFO_0004286I74127—616
EmbolismD004617——1—12
Covid-19D000086382U07.1——2——2
Aortic valve stenosisD001024EFO_0000266Q25.1——2——2
Cerebral hemorrhageD002543——1——1
Hypertensive intracranial hemorrhageD020299——1——1
Subarachnoid hemorrhageD013345EFO_0000713I60——1——1
Subdural hematomaD006408HP_0100309——1——1
Cerebral intraventricular hemorrhageD000074042——1——1
Atrial flutterD001282EFO_0003911——1——1
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—21——14
Replacement arthroplasty hipD019644—2———2
Peripheral arterial diseaseD058729EFO_0004265—1———1
Hiv infectionsD015658EFO_0000764B20—1———1
InflammationD007249—1———1
Embolism and thrombosisD016769—1———1
Replacement arthroplasty kneeD019645—1———1
Mitral valve stenosisD008946EFO_0007372—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Coagulation protein disordersD0201471————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Oral surgeryD013515————11
Postoperative complicationsD011183————11
Oral surgical proceduresD019647————11
MenorrhagiaD008595N92.0————11
Intracranial arteriosclerosisD002537EFO_1000860I67.2————11
Heart valve diseasesD006349EFO_0009551I08————11
Heart failureD006333EFO_0003144I50————11
FrailtyD000073496R53.1————11
Myocardial infarctionD009203EFO_0000612I21————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEDOXABAN
INNedoxaban
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 classantithrombotics, 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-ID480449-70-5
RxCUI1599538
ChEMBL IDCHEMBL1269025
ChEBI ID85973
PubChem CID10280735
DrugBankDB09075
UNII IDNDU3J18APO (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
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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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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