Gilteritinib
- Generic Name
- Gilteritinib
- Brand Names
- Xospata
- Drug Type
- Small Molecule
- Chemical Formula
- C29H44N8O3
- CAS Number
- 1254053-43-4
- Unique Ingredient Identifier
- 66D92MGC8M
- Background
Gilteritinib, also known as ASP2215, is a small molecule part of the FLT3 tyrosine kinase inhibitors that presented a greater selectivity and potency when compared with other agents from this group. It is a pyrazinecarboxamide derivative that showed high selectivity to FLT3 preventing the c-Kit -driven myelosuppression observed in other therapies. Gilteritinib was developed by Astellas Pharma and FDA approved on November 28, 2018. This drug was approved after being designed as an orphan drug with a fast track and priority review status.
- Indication
Gilteritinib is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with an FLT3 mutation detected by an FDA-approved test. This indication was expanded for a companion diagnostic to include use with gilteritinib such as the LeukoStrat CDx FLT3 Mutation Assay.
Acute myeloid leukemia is cancer that impacts the blood and bone marrow with a rapid progression. This condition produces low numbers of normal blood cells and the requirement of continuous need for transfusions.
- Associated Conditions
- Relapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML
- Conditions
- AML, AdultChemotherapy Effect
- Interventions
- First Posted Date
- 2022-01-05
- Last Posted Date
- 2024-10-03
- Lead Sponsor
- Chen Suning
- Target Recruit Count
- 188
- Registration Number
- NCT05177731
- Locations
- 🇨🇳
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology, Suzhou, Jiangsu, China
A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)
- Conditions
- Acute Myeloid LeukemiaRelapsed Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia
- Interventions
- First Posted Date
- 2021-08-31
- Last Posted Date
- 2024-08-07
- Lead Sponsor
- Kronos Bio
- Target Recruit Count
- 24
- Registration Number
- NCT05028751
- Locations
- 🇪🇸
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona, Spain
🇺🇸The Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML
- Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation
- Interventions
- First Posted Date
- 2021-08-27
- Last Posted Date
- 2025-05-21
- Target Recruit Count
- 22
- Registration Number
- NCT05024552
- Locations
- 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission
- Conditions
- Acute Myeloid Leukemia
- Interventions
- First Posted Date
- 2021-08-18
- Last Posted Date
- 2025-01-08
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 125
- Registration Number
- NCT05010772
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
- Conditions
- Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaMyelodysplastic Syndrome
- Interventions
- First Posted Date
- 2021-08-18
- Last Posted Date
- 2025-03-25
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 42
- Registration Number
- NCT05010122
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation
- Conditions
- Leukemia, Myeloid, AcuteLeukemia, Lymphocytic, Acute
- Interventions
- First Posted Date
- 2021-08-03
- Last Posted Date
- 2025-04-02
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 362
- Registration Number
- NCT04988555
- Locations
- 🇺🇸
Hoag Family Cancer Center, Newport Beach, California, United States
🇺🇸Colorado Blood Cancer Institute, Denver, Colorado, United States
🇺🇸University of Miami, Miami, Florida, United States
A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function
- Conditions
- Pharmacokinetics of ASP2215Normal Renal FunctionRenal ImpairedGilteritinib
- Interventions
- First Posted Date
- 2021-01-07
- Last Posted Date
- 2024-11-05
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 17
- Registration Number
- NCT04699877
- Locations
- 🇺🇸
Orange County Research Institute, Tustin, California, United States
🇺🇸National Institute of Clinical Research, Garden Grove, California, United States
🇺🇸Orlando Clinical Research Center, Orlando, Florida, United States
A Study to Assess the Safety of Xospata in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-Like Tyrosine Kinase 3 (FLT3) Mutation
- Conditions
- Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
- Interventions
- First Posted Date
- 2020-12-31
- Last Posted Date
- 2025-04-24
- Lead Sponsor
- Astellas Pharma Korea, Inc.
- Target Recruit Count
- 33
- Registration Number
- NCT04691648
- Locations
- 🇰🇷
Site KR82013, Wonju-si, Gangwon-do, Korea, Republic of
🇰🇷Site KR82006, Goyang-si, Gyeonggi-do, Korea, Republic of
🇰🇷Site KR82003, Jeollanam-do, Hwasun-gun, Korea, Republic of
Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation
- Conditions
- Recurrent Acute Myeloid Leukemia
- Interventions
- First Posted Date
- 2020-12-07
- Last Posted Date
- 2022-06-09
- Lead Sponsor
- City of Hope Medical Center
- Registration Number
- NCT04655391
- Locations
- 🇺🇸
City of Hope Meidcal Center, Duarte, California, United States
A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- First Posted Date
- 2020-04-07
- Last Posted Date
- 2024-05-31
- Lead Sponsor
- Celgene
- Target Recruit Count
- 22
- Registration Number
- NCT04336982
- Locations
- 🇺🇸
Local Institution - 104, San Francisco, California, United States
🇺🇸Local Institution - 103, Boston, Massachusetts, United States
🇨🇦Local Institution - 201, Toronto, Ontario, Canada
Drug Development Updates
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