Last reviewed 2026-04-22 · How we verify

Gilteritinib (GILT)

Gilteritinib is a tyrosine kinase inhibitor that selectively targets FLT3 (FMS-like tyrosine kinase 3) to inhibit proliferation of acute myeloid leukemia cells.

Gilteritinib is a tyrosine kinase inhibitor that selectively targets FLT3 (FMS-like tyrosine kinase 3) to inhibit proliferation of acute myeloid leukemia cells. Used for Acute myeloid leukemia (AML) with FLT3 mutation, relapsed or refractory, Acute myeloid leukemia (AML) with FLT3 mutation, newly diagnosed (in combination with chemotherapy).

At a glance

Mechanism of action

Gilteritinib binds to and inhibits FLT3, a receptor tyrosine kinase that is frequently mutated or overexpressed in acute myeloid leukemia (AML). By blocking FLT3 signaling, the drug suppresses the growth and survival of leukemic blasts. It has activity against both FLT3-ITD (internal tandem duplication) and FLT3-TKD (tyrosine kinase domain) mutations.

Approved indications

• Acute myeloid leukemia (AML) with FLT3 mutation, relapsed or refractory
• Acute myeloid leukemia (AML) with FLT3 mutation, newly diagnosed (in combination with chemotherapy)

Common side effects

• Febrile neutropenia
• Thrombocytopenia
• Anemia
• Nausea
• Diarrhea
• Vomiting
• Fatigue
• QT prolongation

Key clinical trials

• Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment (PHASE2)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Gilteritinib (GILT) CI brief — competitive landscape report
• Gilteritinib (GILT) updates RSS · CI watch RSS
• Technische Universität Dresden portfolio CI