Drug Name |
Baloxavir marboxil |
Drug ID |
BADD_D02520 |
Description |
Baloxavir marboxil is an antiviral drug developed by Shionogi Co., a Japanese pharmaceutical company and Roche for the treatment of influenza A and influenza B infections. The drug was initially approved for use in Japan in February 2018 and approved by the FDA on October 24, 2018 [L4779], [A39895] for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours [FDA label]. Baloxavir marboxil, a cap-endonuclease inhibitor, has a unique mechanism of action when compared to the currently existing neuraminidase inhibitor drug class used to treat influenza infections [A39894]. |
Indications and Usage |
For the treatment of influenza A and B virus infection [L1473, L1475], [FDA label] in patients 12 and older who have been symptomatic for no more than 48 hours.
Clinical trials of this drug did not include subjects 65 years of age and older to determine whether they respond in a different way than younger subjects [FDA label]. |
Marketing Status |
approved; investigational |
ATC Code |
J05AX25 |
DrugBank ID |
DB13997
|
KEGG ID |
D11021
|
MeSH ID |
C000628402
|
PubChem ID |
124081896
|
TTD Drug ID |
D0O5AG
|
NDC Product Code |
50242-583; 12806-8600; 12806-8770; 53044-877; 53044-828; 53044-004; 50242-877; 14501-0109; 53044-836; 62128-0394; 50242-860; 53044-860 |
UNII |
505CXM6OHG
|
Synonyms |
baloxavir | (12aR)-12-((11S)-7,8-difluoro-6,11-dihydrodibenzo(b,e)thiepin-11-yl)-7-hydroxy-3,4,12,12a-tetrahydro-1h-(1,4)oxazino(3,4-c)pyrido(2,1-f)(1,2,4)triazine-6,8-dione | Xofluza | baloxavir marboxil | (((12aR)-12-((11S)-7,8-difluoro-6,11-dihydrodibenzo(b,E)thiepin-11-yl)-6,8-dioxo-3,4,6,8,12,12ahexahydro-1H-(1,4)oxazino(3,4-C)pyrido(2,1-F)(1,2,4)triazin-7-yl)oxy)methyl methyl carbonate |