Friday, July 10, 2026

Drug profile · INN

gilteritinib fumarate

gilteritinib fumarate (XOSPATA) is a tyrosine-protein kinase receptor flt3 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved PMDA: approved
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — gilteritinib fumarate
US status
approved
Class
Route
ORAL
Patents
0
Programs
2
Data quality
0.84

Quick answer

gilteritinib fumarate (XOSPATA) is a tyrosine-protein kinase receptor flt3 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN gilteritinib fumarate
Brand XOSPATA
Mechanism Tyrosine-protein kinase receptor FLT3 inhibitor
Target Receptor-type tyrosine-protein kinase FLT3
Route ORAL
Formulation TABLET

Mechanism of action

Tyrosine-protein kinase receptor FLT3 inhibitor

Primary target: Receptor-type tyrosine-protein kinase FLT3

Approval history

Authority Status Date
FDA approved
PMDA approved

Pipeline programs

  1. Gilteritinib Phase 3 · First People's Hospital · Acute Myeloid Leukemia (AML)
  2. Gilteritinib Phase 1 · Jazz Pharmaceuticals Ireland · Acute Myeloid Leukemia With FLT3/ITD Mutation

Related & competitor drugs

  1. quizartinib dihydrochloride Tyrosine-protein kinase receptor FLT3 inhibitor
  2. gilteritinib Antineoplastic and immunomodulating agents (L01)
  3. quizartinib hydrochloride Tyrosine-protein kinase receptor FLT3 inhibitor

Frequently asked questions

What is gilteritinib fumarate?

gilteritinib fumarate (XOSPATA) is a tyrosine-protein kinase receptor flt3 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for gilteritinib fumarate?

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

What is the US approval status of gilteritinib fumarate?

gilteritinib fumarate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.