XOSPATA (gilteritinib fumarate)
Xospata treats adults with acute myeloid leukemia (AML) that has either returned or failed to respond to previous treatments. It helps patients whose cancer cells carry a specific genetic change known as a FLT3 mutation. This medication is used when a diagnostic test confirms the presence of this mutation in the patient's leukemic cells.
How XOSPATA Works
This drug works by blocking the activity of several proteins called receptor tyrosine kinases, specifically targeting the FLT3 receptor. By inhibiting these signals, it stops the growth and spread of leukemia cells and triggers programmed cell death. This process is effective against various forms of the mutation, including FLT3-ITD and tyrosine kinase domain mutations.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-11-28
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- TABLET
XOSPATA Approval History
What XOSPATA Treats
1 indicationsXOSPATA is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Myeloid Leukemia
XOSPATA Boxed Warning
DIFFERENTIATION SYNDROME Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precautions ( ...
WARNING: DIFFERENTIATION SYNDROME Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution. ( 5.1 , 6.1 )
XOSPATA Target & Pathway
ProTarget
XOSPATA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in XOSPATA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications XOSPATA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to XOSPATA
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04293562 | AAML1831 NCI-2020-00546, AAML1831 | Ph 3 | recruiting | A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations |
| NCT06022003 OGILAR | FILOAML-RR-01 OGILAR 2022-501372-25-00 | Ph 2 | recruiting | Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia |
| NCT04655391 | 20456 NCI-2020-10595, 20456 | Ph 1 | withdrawn | Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XOSPATA FDA Label Details
Indications & Usage
FDA Label (PDF)XOSPATA is indicated for the treatment of Acute Myeloid Leukemia.
WARNING: DIFFERENTIATION SYNDROME Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or pe...
XOSPATA Patents & Exclusivity
Patents (8 active)
Pro Intelligence Preview
Deep insights for XOSPATA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 8 active patents
Trial Analysis
- • 3 total trials
- • Stage: Growth
Competitive Landscape
- • 18 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment