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Xadago(safinamide)
Xadago (safinamide) is a small molecule pharmaceutical. Safinamide was first approved as Xadago on 2015-02-23. It is used to treat parkinson disease in the USA. It has been approved in Europe to treat parkinson disease. The pharmaceutical is active against amine oxidase [flavin-containing] B.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
Trade Name
FDA
EMA
Xadago
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Safinamide mesylate
Tradename
Company
Number
Date
Products
XADAGOMDD US OperationsN-207145 RX2017-03-21
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
xadagoNew Drug Application2020-12-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
parkinson diseaseEFO_0002508D010300G20
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Safinamide Mesylate, Xadago, Mdd Us
82833802031-03-21U-1993
80765152028-12-10DS, DPU-1993
82784852027-06-08DPU-1993
ATC Codes
N: Nervous system drugs
— N04: Anti-parkinson drugs
— N04B: Dopaminergic agents
— N04BD: Mao b inhibitors, dopaminergic anti-parkinson drugs
— N04BD03: Safinamide
HCPCS
No data
Clinical
Clinical Trials
25 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
Parkinson diseaseD010300EFO_0002508G201494219
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug-induced dyskinesiaD004409EFO_1000904——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple system atrophyD019578—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—3————3
Renal insufficiencyD051437HP_0000083N191————1
Hepatic insufficiencyD0485501————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSAFINAMIDE
INNsafinamide
Description
Safinamide is an amino acid amide.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@H](NCc1ccc(OCc2cccc(F)c2)cc1)C(N)=O
Identifiers
PDB—
CAS-ID133865-89-1
RxCUI1922448
ChEMBL IDCHEMBL396778
ChEBI ID—
PubChem CID131682
DrugBankDB06654
UNII ID90ENL74SIG (ChemIDplus, GSRS)
Target
Agency Approved
MAOB
MAOB
Organism
Homo sapiens
Gene name
MAOB
Gene synonyms
NCBI Gene ID
4129
Protein name
amine oxidase [flavin-containing] B
Protein synonyms
adrenalin oxidase, MAO, brain, MAO, platelet, MAO-B, Monoamine oxidase type B, tyramine oxidase
Uniprot ID
Q7Z6S2
Mouse ortholog
Maob (109731)
amine oxidase [flavin-containing] B (Q8C0B2)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Xadago - Supernus Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 674 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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66,415 adverse events reported
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