Friday, July 10, 2026

Drug profile · INN

gilteritinib

gilteritinib (XOSPATA) is a tyrosine-protein kinase receptor flt3 inhibitor. Associated with Astellas Pharma Inc.

EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L01) L01EX13
Patents linked 0
Pipeline programs 12
News articles 0
Drug details — gilteritinib
Class
Antineoplastic and immunomodulating agents (L01)
Route
Patents
0
Programs
12
Data quality
0.83

Quick answer

gilteritinib (XOSPATA) is a tyrosine-protein kinase receptor flt3 inhibitor. Associated with Astellas Pharma Inc.

Key facts

INN gilteritinib
Brand XOSPATA
Mechanism Tyrosine-protein kinase receptor FLT3 inhibitor
Target Receptor-type tyrosine-protein kinase FLT3
Therapeutic class Antineoplastic and immunomodulating agents (L01)
ATC code L01EX13

Mechanism of action

Tyrosine-protein kinase receptor FLT3 inhibitor

Primary target: Receptor-type tyrosine-protein kinase FLT3

Approval history

Authority Status Date
EMA approved
TGA approved

Pipeline programs

  1. 2215-CL-0201 Phase 3 · Astellas Pharma · Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in
  2. Gilteritinib Phase 3 · First People's Hospital · Acute Myeloid Leukemia (AML)
  3. IRST204.07 Phase 3 · Istituto Gentili Italia · Acute myeloid leukemia
  4. gilteritinib Phase 3 · Astellas Pharma · Acute Myeloid Leukemia (AML)
  5. 2215-CL-0603 Phase 2 · Astellas Pharma · FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplicatio
  6. GVA + HDAC Consolidation & Gilteritinib Maintenance Phase 2 · First People's Hospital · Acute Myeloid Leukemia
  7. Gilteritinib Phase 2 · Astellas Pharma · Non-Small-Cell Lung Cancer
  8. Xospata 40 mg film-coated tablets Phase 2 · Createrna Science and · Acute myeloid leukaemia, Acute myeloid leukaemia

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is gilteritinib?

gilteritinib (XOSPATA) is a tyrosine-protein kinase receptor flt3 inhibitor. Associated with Astellas Pharma Inc.

What is the brand name for gilteritinib?

XOSPATA is a marketed brand name for gilteritinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.