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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_0000275I48.05882041
Venous thrombosisD020246HP_0004936I82.401332211
StrokeD020521EFO_0000712I63.932217
Pulmonary embolismD011655EFO_0003827I263126
HemorrhageD006470MP_0001914R5821115
NeoplasmsD009369C801225
Ischemic strokeD00008324211125
ThrombosisD0139273115
ThromboembolismD013923HP_00019072114
Coronary artery diseaseD003324I25.1213
Show 4 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Venous thromboembolismD054556EFO_0004286I74127616
EmbolismD004617112
Covid-19D000086382U07.122
Aortic valve stenosisD001024EFO_0000266Q25.122
Cerebral hemorrhageD00254311
Hypertensive intracranial hemorrhageD02029911
Subarachnoid hemorrhageD013345EFO_0000713I6011
Subdural hematomaD006408HP_010030911
Cerebral intraventricular hemorrhageD00007404211
Atrial flutterD001282EFO_000391111
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients2114
Replacement arthroplasty hipD01964422
Peripheral arterial diseaseD058729EFO_000426511
Hiv infectionsD015658EFO_0000764B2011
InflammationD00724911
Embolism and thrombosisD01676911
Replacement arthroplasty kneeD01964511
Mitral valve stenosisD008946EFO_000737211
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Coagulation protein disordersD02014711
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Oral surgeryD01351511
Postoperative complicationsD01118311
Oral surgical proceduresD01964711
MenorrhagiaD008595N92.011
Intracranial arteriosclerosisD002537EFO_1000860I67.211
Heart valve diseasesD006349EFO_0009551I0811
Heart failureD006333EFO_0003144I5011
FrailtyD000073496R53.111
Myocardial infarctionD009203EFO_0000612I2111
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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