XOSPATA

Peak

gilteritinib

NDAORALTABLETPriority Review
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

kinases, including FMS-like tyrosine kinase 3 (FLT3). Gilteritinib demonstrated the ability to inhibit FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, tyrosine kinase domain mutations (TKD) FLT3-D835Y and FLT3-ITD-D835Y, and it induced apoptosis in…

Clinical Trials (5)

NCT07140016Phase 1Recruiting

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
NCT06734585N/ACompleted

Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant

Started Jan 2025
114 enrolled
Acute Myeloid Leukemia
NCT06235801Phase 1/2Recruiting

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
NCT05756777Phase 1Recruiting

A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)

Started Jun 2023
36 enrolled
Acute Myeloid Leukemia (AML)
NCT05199051Phase 2Active Not Recruiting

A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML

Started Jun 2023
19 enrolled
AMLLeukaemia (Acute Myeloid)

Loss of Exclusivity

LOE Date
Jul 1, 2036
125 months away
Patent Expiry
Jul 1, 2036

Patent Records (5)

Patent #ExpiryTypeUse Code
9487491
Jul 28, 2030
U-2456
8969336
Nov 28, 2032
SubstanceProduct
11938131
Jul 1, 2036
Product
11938132
Jul 1, 2036
Product
10786500
Jul 1, 2036
Product