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Gilteritinib · Xospata, ASP-2215

Small molecule · Inhibitor of FMS-like tyrosine kinase 3 (FLT3) · developed by Astellas

Approved FDA, Nov 2018
1 Registered trials

What is Gilteritinib?

Gilteritinib is an orally bioavailable small-molecule inhibitor of receptor tyrosine kinases, primarily FLT3, and also AXL, ALK, and LTK. It binds to and inhibits both wild-type and mutated forms of these kinases, blocking their signal transduction and reducing proliferation in cancer cells.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Xospata, ASP-2215
Drug type
Small molecule
Targets
FMS-like tyrosine kinase 3 (FLT3), AXL (secondary target), anaplastic lymphoma kinase (ALK) (secondary target), leukocyte receptor tyrosine kinase (LTK) (secondary target)
Mechanism
Inhibitor of FMS-like tyrosine kinase 3 (FLT3)
Pathways
FLT3-mediated signal transduction, AXL-mediated signal transduction, ALK-mediated signal transduction, LTK-mediated signal transduction
Therapy area
Hematology, Oncology
Developer
Astellas
In trials of
SNDX
FDA status
Approved as Xospata (November 28, 2018), NDA211349 · FDA label
UNII
66D92MGC8M

✅ FDA-approved uses

From the indications section of the FDA label (version of Jan 1, 2022). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT03013998 Phase 2/3 Previously Untreated Relapsed Refractory Acute Myeloid Leukemia Recruiting SNDX

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Other drugs acting on FLT3

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.