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Drug ReportsEdoxaban
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 Application2025-07-10
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
EDOXABAN TOSYLATE, SAVAYSA, DAIICHI SANKYO INC
2026-10-18M-14
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
208 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 fibrillationD001281EFO_0000275I48.0—914195495
ThromboembolismD013923——13821630
StrokeD020521EFO_0000712I63.9—5871230
Venous thromboembolismD054556EFO_0004286I7412721628
ThrombosisD013927——14461227
Ischemic strokeD000083242———3541121
Venous thrombosisD020246—I82.401343819
HemorrhageD006470MP_0001914R582163517
EmbolismD004617——1142412
Pulmonary embolismD011655EFO_0003827I261—32511
Show 32 more
Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———43——17
Peripheral arterial diseaseD058729EFO_0004265——1——12
Blood coagulationD001777GO_0007596——1——12
Replacement arthroplasty hipD019644———2———2
Hiv infectionsD015658EFO_0000764B20—1———1
InflammationD007249MP_0001845——1———1
Embolism and thrombosisD016769———1———1
Replacement arthroplasty kneeD019645———1———1
Mitral valve stenosisD008946EFO_0007372——1———1
Liver cirrhosisD008103EFO_0001422K74.0—1———1
Show 1 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Coagulation protein disordersD020147——2————2
Pancreatic neoplasmsD010190EFO_0003860C251————1
Bariatric surgeryD050110——1————1
Indications Without Phase
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)Loading
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
RxCUI—
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
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Savaysa
Adverse Events
Top Adverse Reactions
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9,526 adverse events reported
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