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 (discontinued: 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 | 2024-07-09 |
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
20 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 | 10 | 3 | 2 | 17 |
| Virus diseases | D014777 | — | B34 | — | — | — | 3 | — | 3 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | 1 | — | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | 1 | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | 1 | — | 1 |
| Transplantation | D014180 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | — | — | — | 2 | — | — | 2 |
| 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 |
| Syndrome | D013577 | — | — | — | — | 1 | — | — | 1 |
| Influenza b virus | D009981 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic neoplasms | D019337 | — | — | — | 1 | — | — | — | 1 |
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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Trends
PubMed Central
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Additional graphs summarizing 1,114 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,799 adverse events reported
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