Gilteritinib

Generic Name: Gilteritinib

Brand Names: Xospata

Drug Type: Small Molecule

Chemical Formula: C_₂₉H_₄₄N_₈O_₃

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

Clinical Trials

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

Recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Gilteritinib

First Posted Date: 2024-12-16

Last Posted Date: 2025-02-04

Lead Sponsor: Astellas Pharma Singapore Pte. Ltd.

Target Recruit Count: 200

Registration Number: NCT06734585

Locations: 🇭🇰
HK852001, Hong Kong, Hong Kong

Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment

Phase 2

Not yet recruiting

Conditions: AML - Acute Myeloid Leukemia

Interventions: Drug: Gilteritinib (GILT)
Drug: Venetoclax (VEN)
Drug: Azacitidine (AZA)

First Posted Date: 2024-11-20

Last Posted Date: 2025-02-26

Lead Sponsor: Technische Universität Dresden

Target Recruit Count: 60

Registration Number: NCT06696183

Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia

Phase 2

Not yet recruiting

Conditions: Acute Myeloid Leukemia
FLT3 Gene Mutation
Adult AML
Diagnosis

Interventions: Drug: Gilteritinib

First Posted Date: 2024-10-31

Last Posted Date: 2025-03-12

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 80

Registration Number: NCT06667973

The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation

Phase 1

Not yet recruiting

Conditions: FLT3 Gene Mutation
AML

Interventions: Drug: Gilteritinib
Drug: Cytarabine

First Posted Date: 2024-08-20

Last Posted Date: 2024-08-20

Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Target Recruit Count: 36

Registration Number: NCT06561880

Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)

Phase 2

Recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Azacitidine
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Gilteritinib
Drug: Venetoclax

First Posted Date: 2024-03-19

Last Posted Date: 2025-05-18

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 147

Registration Number: NCT06317649

Locations: 🇺🇸
Banner University Medical Center - Tucson, Tucson, Arizona, United States
🇺🇸
University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
🇺🇸
Kaiser Permanente Dublin, Dublin, California, United States

and more 170 locations

A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

Phase 1

Recruiting

Conditions: Myeloid Leukemia

Interventions: Drug: Gilteritinib
Drug: Momelotinib

First Posted Date: 2024-02-01

Last Posted Date: 2025-02-10

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 20

Registration Number: NCT06235801

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

Gilteritinib for the Treatment of ALK NSCLC

Phase 1

Recruiting

Conditions: Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Echocardiography
Drug: Gilteritinib
Procedure: Magnetic Resonance Imaging
Other: Questionnaire Administration

First Posted Date: 2024-01-26

Last Posted Date: 2025-02-25

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 30

Registration Number: NCT06225427

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia With FLT3/ITD Mutation
Acute Myeloid Leukemia With KMT2A Rearrangement
Acute Myeloid Leukemia With NPM1 Mutation
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration and Biopsy
Drug: Gilteritinib
Drug: Revumenib

First Posted Date: 2024-01-24

Last Posted Date: 2025-04-02

Lead Sponsor: Uma Borate

Target Recruit Count: 30

Registration Number: NCT06222580

Locations: 🇺🇸
UNC Hospitals, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML

Phase 2

Recruiting

Conditions: AML, Childhood
Acute Myeloid Leukemia

Interventions: Drug: Homoharringtonine
Drug: Mitoxantrone hydrochloride liposome
Drug: Cytarabine
Drug: Recombinant Human Granulocyte Colony-Stimulating Factor
Drug: Etoposide
Drug: Idarubicin Hydrochloride
Drug: Venetoclax
Drug: Sorafenib
Drug: Gilteritinib
Drug: Avapritinib

First Posted Date: 2024-01-24

Last Posted Date: 2024-08-22

Lead Sponsor: Children's Hospital of Soochow University

Target Recruit Count: 500

Registration Number: NCT06221683

Locations: 🇨🇳
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
🇨🇳
XiangYa Hospital Central South University, Changsha, Hunan, China
🇨🇳
Children's Hospital of Soochow University, Suzhou, Jiangsu, China

and more 10 locations

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

Phase 2

Recruiting

Conditions: AML, Adult
Refractory AML
Relapsed Adult AML
FLT3-TKD Mutation
FLT3-ITD

Interventions: Drug: AzaCITIDine Oral Tablet
Drug: Xospata

First Posted Date: 2023-09-01

Last Posted Date: 2025-03-24

Lead Sponsor: French Innovative Leukemia Organisation

Target Recruit Count: 33

Registration Number: NCT06022003

Locations: 🇫🇷
Paris Saint Louis, Paris, France
🇫🇷
Créteil CHU HENRI MONDOR, Créteil, France
🇫🇷
Angers CHU, Angers, France

and more 17 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy