NDAORALTABLETPriority Review
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
25
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XOSPATA (gilteritinib) is an oral small-molecule tyrosine kinase inhibitor developed by Astellas and approved by the FDA on November 28, 2018. It is indicated for acute myeloid leukemia (AML), myelodysplastic syndrome with excess blasts-2 (MDS-EB-2), non-small cell lung cancer, and anaplastic lymphoma kinase positive malignancies. The drug functions as a FLT3 inhibitor and represents a targeted therapy option for patients with specific molecular alterations in hematologic and solid tumors.
$0.1BPart D
10.2 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (25)
FLT3-ITD Targeted Therapy in Fit AML Patients
Started Dec 2026
230 enrolled
AML (Acute Myeloid Leukemia)
A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
Started Sep 2025
40 enrolled
Non-small Cell Lung Cancer (NSCLC)Anaplastic Lymphoma Kinase (ALK) Positive
Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant
Started Jan 2025
114 enrolled
Acute Myeloid Leukemia
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
Started May 2024
20 enrolled
Myeloid Leukemia
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
Started Jun 2023
18 enrolled
Acute Myeloid Leukemia (AML)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.