Xofluza(baloxavir marboxil)
Xofluza (baloxavir marboxil) is a small molecule pharmaceutical. Baloxavir marboxil was first approved as Xofluza on 2018-10-24. It is used to treat influenza a virus and influenza b virus in the USA. It has been approved in Europe to treat human influenza.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| respiratory tract diseases | D012140 |
Trade Name
FDA
EMA
Xofluza
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xofluza | New Drug Application | 2023-06-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| influenza a virus | NCBITaxon_11320 | D009980 | — |
| influenza b virus | — | D009981 | — |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
18 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Human influenza | D007251 | EFO_0007328 | J11.1 | — | 3 | 7 | 2 | — | 11 |
| Virus diseases | D014777 | — | B34 | — | — | — | 2 | — | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | — | — | — | 1 | — | — | 1 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | 1 | — | — | 1 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Baloxavir marboxil |
| INN | baloxavir marboxil |
| Description | Baloxavir marboxil, sold under the brand name Xofluza, is an antiviral medication for treatment of influenza A and influenza B. It was approved for medical use both in Japan and in the United States in 2018, and is taken as a single dose by mouth. It may reduce the duration of flu symptoms by about a day, but is prone to selection of resistant mutants that render it ineffectual.[unreliable medical source?]
|
| Classification | Small molecule |
| Drug class | antivirals |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COC(=O)OCOc1c2n(ccc1=O)N([C@@H]1c3ccccc3SCc3c1ccc(F)c3F)[C@@H]1COCCN1C2=O |
Identifiers
| PDB | — |
| CAS-ID | 1830312-72-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297503 |
| ChEBI ID | — |
| PubChem CID | 124081896 |
| DrugBank | DB13997 |
| UNII ID | 505CXM6OHG (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Xofluza – Roche
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,052 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,509 adverse events reported
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