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 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XOSPATA (gilteritinib) is an oral small-molecule FLT3 inhibitor approved by the FDA in November 2018 for relapsed or refractory acute myeloid leukemia (AML) in adult patients. It targets FLT3-ITD and FLT3-TKD mutations, which drive proliferation in a subset of AML cases.
$90MPart D
PeakStable
9.8 years to LOEDrug is in peak commercial phase with modest Medicare spending, indicating established market penetration but limited growth trajectory for commercial teams.
Mechanism 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
40 enrolled
Myeloid Leukemia
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
Started Oct 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.