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| Clinical data | |
|---|---|
| Trade names | Xospata |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619003 |
| License data | |
| Pregnancy category | |
| Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
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| CAS Number | |
| PubChemCID | |
| DrugBank | |
| ChemSpider | |
| UNII | |
| KEGG | |
| ChEBI | |
| CompTox Dashboard(EPA) | |
| Chemical and physical data | |
| Formula | C29H44N8O3 |
| Molar mass | 552.724 g·mol−1 |
| 3D model (JSmol) | |
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Gilteritinib, sold under the brand nameXospata, is an anti-cancer drug.[6]
Gilteritinib acts as aninhibitor ofFLT3, hence it is atyrosine kinase inhibitor.[7]
Gilteritinib wasdeveloped byAstellas Pharma.
In April 2018, Astellas filed anew drug application with theFood and Drug Administration for gilteritinib for the treatment of adult patients withFLT3 mutation–positive (both ITD and TKD[8]) relapsed or refractoryacute myeloid leukemia (AML).[9]
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.[10][4]
Gilteritinib was grantedorphan drug status by the U.S. FDA, the European Commission (EC) and the Japan Ministry of Health, Labor and Welfare, for some AML patients.[11]
Gilteritinib was approved for medical use in Australia in March 2020.[12]
