Gilteritinib

Gilteritinib

Clinical data
Trade names	Xospata
AHFS/Drugs.com	Monograph
MedlinePlus	a619003
License data	US DailyMed: Gilteritinib
Pregnancy category	AU: D
Routes of administration	By mouth
ATC code	L01EX13 (WHO)
Legal status
Legal status	AU: S4 (Prescription only) CA: ℞-only UK: POM (Prescription only) US: ℞-only EU: Rx-only In general: ℞ (Prescription only)
Identifiers
IUPAC name 6-Ethyl-3-[3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]anilino]-5-(oxan-4-ylamino)pyrazine-2-carboxamide
CAS Number	1254053-43-4
PubChem CID	49803313
DrugBank	DB12141
ChemSpider	32055842
UNII	66D92MGC8M
KEGG	D10709 as salt: D10800
ChEBI	CHEBI:145372
Chemical and physical data
Formula	C29H44N8O3
Molar mass	552.724 g·mol−1
3D model (JSmol)	Interactive image
SMILES CCc1nc(C(=O)N)c(Nc2ccc(N3CCC(CC3)N4CCN(C)CC4)c(OC)c2)nc1NC5CCOCC5
InChI InChI=1S/C29H44N8O3/c1-4-23-28(31-20-9-17-40-18-10-20)34-29(26(33-23)27(30)38)32-21-5-6-24(25(19-21)39-3)37-11-7-22(8-12-37)36-15-13-35(2)14-16-36/h5-6,19-20,22H,4,7-18H2,1-3H3,(H2,30,38)(H2,31,32,34) Key:GYQYAJJFPNQOOW-UHFFFAOYSA-N

Gilteritinib, sold under the brand name Xospata, is an anti-cancer drug. It acts as an inhibitor of FLT3, hence it is a tyrosine kinase inhibitor.

It was developed by Astellas Pharma.

In April 2018, Astellas filed a new drug application with the Food and Drug Administration for gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML).

In November 2018, the FDA approved gilteritinib for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

Gilteritinib was granted orphan drug status by the U.S. FDA, the European Commission (EC) and the Japan Ministry of Health, Labor and Welfare, for some AML patients.

Gilteritinib was approved for medical use in Australia in March 2020.

Further reading

• AusPAR: Gilteritinib (as fumarate). Therapeutic Goods Administration (TGA) (Report). September 2020.

External links

• "Gilteritinib". Drug Information Portal. U.S. National Library of Medicine.
• "Gilteritinib fumarate". NCI Drug Dictionary. National Cancer Institute.
• "Gilteritinib fumarate". National Cancer Institute. 17 January 2019.