Xadago(safinamide)
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 diseases | D009422 |
Trade Name
FDA
EMA
Xadago (generic drugs available since 2023-06-14)
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 |
|---|---|---|---|---|
| XADAGO | MDD US Operations | N-207145 RX | 2017-03-21 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xadago | New Drug Application | 2023-12-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| parkinson disease | EFO_0002508 | D010300 | G20 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 4 | 10 | 4 | 3 | 21 |
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyskinesias | D020820 | HP_0002310 | G24 | — | 1 | 1 | — | — | 2 |
| Drug-induced dyskinesia | D004409 | EFO_1000904 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Shy-drager syndrome | D012791 | EFO_1001050 | — | — | 1 | — | — | — | 1 |
| Multiple system atrophy | D019578 | — | — | — | 1 | — | — | — | 1 |
| Atrophy | D001284 | — | — | — | 1 | — | — | — | 1 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | 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 insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Safinamide |
| INN | safinamide |
| 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-ID | 133865-89-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL396778 |
| ChEBI ID | — |
| PubChem CID | 131682 |
| DrugBank | DB06654 |
| UNII ID | 90ENL74SIG (ChemIDplus, GSRS) |
Target
Agency Approved
MAOB
MAOB
Alternate
No data
Variants
No data
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Xadago – Supernus Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 940 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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394 adverse events reported
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