Skip to content
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.
Download report
Favorite
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
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)
Baloxavir marboxil
Tradename
Company
Number
Date
Products
XOFLUZAGenentechN-210854 RX2018-10-24
3 products, RLD, RS
XOFLUZAGenentechN-214410 RX2020-11-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
xofluzaNew Drug Application2022-08-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
influenza a virusNCBITaxon_11320D009980—
influenza b virus—D009981—
Agency Specific
FDA
EMA
Expiration
Code
BALOXAVIR MARBOXIL, XOFLUZA, GENENTECH INC
2023-10-24NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Baloxavir Marboxil, Xofluza, Genentech Inc
112611982038-09-25DP
107598142037-08-09DS, DP
113061062037-08-09U-2816, U-3000
103924062036-04-27DP
106333972036-04-27U-2816, U-3000
89874412031-09-21DS, DP
89277102031-05-05DP
98158352030-06-14DP
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AX: Other antivirals in atc
— J05AX25: Baloxavir marboxil
HCPCS
No data
Clinical
Clinical Trials
11 clinical trials
View more details
Mock data
Subscribe for the real data
Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Human influenzaD007251EFO_0007328J11.1—162—9
Virus diseasesD014777B34———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PneumoniaD011014EFO_0003106J18——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—————11
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common nameBALOXAVIR MARBOXIL
INNbaloxavir marboxil
Description
Baloxavir marboxil, sold under the brand name Xofluza, is an antiviral medication for treatment of influenza A and influenza B flu. 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.
Classification
Small molecule
Drug classantivirals
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-ID1985606-14-1
RxCUI—
ChEMBL IDCHEMBL4297503
ChEBI ID—
PubChem CID124081896
DrugBankDB13997
UNII ID505CXM6OHG (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Xofluza - Roche
$
€
£
₣
Mock data
Subscribe for the real data
Mock data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Additional graphs summarizing 908 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
10,250 adverse events reported
View more details