ASP2215 (gilteritinib) has been evaluated across numerous clinical trials spanning Phase I, Phase II, and Phase III studies. These investigations primarily target acute myeloid leukemia (AML)—focusing on relapsed or refractory disease, FLT3-ITD and FLT3-TKD mutations, and IDH1-mutated hematologic malignancies—alongside exploratory studies in advanced solid tumors. Sponsored by pharmaceutical entities such as Astellas Pharma and Celgene, academic institutions like M.D. Anderson Cancer Center, and alliances including the French Innovative Leukemia Organisation, these studies encompass recruitment statuses ranging from recruiting and active not recruiting to completed and terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03013998 | RECRUITING | Previously Untreated Relapsed Refractory Acute Myeloid Leukemia |
Beat AML, LLC |
2016-11 | PHASE2; PHASE3 |
| NCT02115295 | RECRUITING | Acute Biphenotypic Leukemia; Acute Myeloid Leukemia; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Blasts 10 Percent or More of Bone Marrow Nucleated Cells; Blasts 10 Percent or More of Peripheral Blood White Cells; de Novo Myelodysplastic Syndrome; Myelodysplastic Syndrome; Previously Treated Myelodysplastic Syndrome; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Acute Myeloid Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia |
M.D. Anderson Cancer Center |
2014-05-19 | PHASE2 |
| NCT07140016 | RECRUITING | Non-small Cell Lung Cancer (NSCLC); Anaplastic Lymphoma Kinase (ALK) Positive |
Astellas Pharma Global Development, Inc. |
2025-09-22 | PHASE1 |
| NCT07755202 | NOT_YET_RECRUITING | Acute Myeloid Leukemia; AML With FLT3 Mutation |
Florian Kuchenbauer |
2026-09-01 | PHASE2 |
| NCT04293562 | RECRUITING | Acute Myeloid Leukemia |
Children's Oncology Group |
2020-07-21 | PHASE3 |
| NCT06317649 | RECRUITING | Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2024-09-27 | PHASE2 |
| NCT05564390 | RECRUITING | Acute Myeloid Leukemia; Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm; Acute Myeloid Leukemia Post Cytotoxic Therapy; Acute Myeloid Leukemia, Myelodysplasia-Related; Myelodysplastic Syndrome |
National Cancer Institute (NCI) |
2024-06-18 | PHASE2 |
| NCT06696183 | RECRUITING | AML - Acute Myeloid Leukemia |
Technische Universität Dresden |
2025-04-25 | PHASE2 |
| NCT07407140 | NOT_YET_RECRUITING | AML, Adult |
Institute of Hematology & Blood Diseases Hospital, China |
2026-04-30 | PHASE3 |
| NCT07259707 | RECRUITING | Acute Myeloid Leukemia; FLT3 Internal Tandem Duplication Positive; Intermediate Risk Acute Myeloid Leukemia; Fit Patients |
First Affiliated Hospital of Zhejiang University |
2026-01-25 | PHASE2 |
| NCT06221683 | RECRUITING | AML, Childhood; Acute Myeloid Leukemia |
Children's Hospital of Soochow University |
2024-01-01 | PHASE2 |
| NCT07425808 | NOT_YET_RECRUITING | AML (Acute Myeloid Leukemia) |
European Organisation for Research and Treatment of Cancer - EORTC |
2026-12-01 | PHASE2; PHASE3 |
| NCT04140487 | RECRUITING | Recurrent Acute Myeloid Leukemia; Recurrent Chronic Myelomonocytic Leukemia; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Refractory Acute Myeloid Leukemia; Refractory Chronic Myelomonocytic Leukemia; Refractory Myelodysplastic/Myeloproliferative Neoplasm |
M.D. Anderson Cancer Center |
2019-12-17 | PHASE1; PHASE2 |
| NCT06667973 | NOT_YET_RECRUITING | Acute Myeloid Leukemia; FLT3 Gene Mutation; Adult AML; Diagnosis |
Gruppo Italiano Malattie EMatologiche dell'Adulto |
2025-06 | PHASE2 |
| NCT06992934 | NOT_YET_RECRUITING | Hematological Malignancies |
Centre Hospitalier Universitaire de Nice |
2026-09 | |
| NCT05520567 | ACTIVE_NOT_RECRUITING | Acute Myeloid Leukemia (AML); FLT3-mutated Acute Myeloid Leukemia |
Astellas Pharma Global Development, Inc. |
2023-01-31 | PHASE1; PHASE2 |
| NCT05199051 | ACTIVE_NOT_RECRUITING | AML; Leukaemia (Acute Myeloid) |
Centre Antoine Lacassagne |
2023-06-03 | PHASE2 |
| NCT07463651 | RECRUITING | Acute Myeloid Leukemia (AML); FLT3-ITD Mutation; Allogeneic Hematopoietic Cell Transplantation (HCT); Maintenance Therapy; Gilteritinib; Sorafenib |
The First Affiliated Hospital of Soochow University |
2026-05-01 | PHASE3 |
| NCT07131059 | RECRUITING | AML, Adult |
Institute of Hematology & Blood Diseases Hospital, China |
2024-05-11 | |
| NCT06265545 | RECRUITING | AML; Refractory; Relapsed |
Institute of Hematology & Blood Diseases Hospital, China |
2024-02-22 | |
| NCT05010122 | RECRUITING | Acute Myeloid Leukemia; Myelodysplastic Syndrome; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia |
M.D. Anderson Cancer Center |
2021-07-08 | PHASE1; PHASE2 |
| NCT06235801 | ACTIVE_NOT_RECRUITING | Myeloid Leukemia |
M.D. Anderson Cancer Center |
2024-05-22 | PHASE1; PHASE2 |
| NCT04988555 | RECRUITING | Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Acute; Multiple Myeloma; Myelodysplastic Syndromes |
Sumitomo Pharma America, Inc. |
2022-02-28 | PHASE1; PHASE2 |
| NCT07032727 | RECRUITING | Targeted Therapy; IDH1-Mutated Malignancies; Mutations |
M.D. Anderson Cancer Center |
2025-09-12 | PHASE2 |
| NCT07548710 | RECRUITING | Acute Myeloid Leukemia |
Ruijin Hospital |
2026-05-01 | PHASE2 |
| NCT05330377 | WITHDRAWN | Acute Myeloid Leukemia |
Ayman H Qasrawi |
2023-03 | PHASE1 |
| NCT06225427 | RECRUITING | Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8 |
University of Michigan Rogel Cancer Center |
2024-07-25 | PHASE1 |
| NCT05756777 | RECRUITING | Acute Myeloid Leukemia (AML) |
Memorial Sloan Kettering Cancer Center |
2023-10-25 | PHASE1 |
| NCT05024552 | RECRUITING | Acute Myeloid Leukemia With FLT3/ITD Mutation |
H. Lee Moffitt Cancer Center and Research Institute |
2022-02-25 | PHASE1 |
| NCT06222580 | RECRUITING | 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 |
Uma Borate |
2024-02-20 | PHASE1 |
| NCT05010772 | RECRUITING | Acute Myeloid Leukemia |
M.D. Anderson Cancer Center |
2021-10-25 | PHASE1 |
| NCT06001788 | RECRUITING | AML; AML With Mutated NPM1; Hematologic Malignancy; KMT2Ar; NPM1 Mutation; MLL Rearrangement; Leukemia; Acute Myeloid Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Acute Leukemia; Neoplasms by Histologic Type |
Kura Oncology, Inc. |
2024-02-22 | PHASE1 |
| NCT05955261 | SUSPENDED | Acute Myeloid Leukemia |
St. Jude Children's Research Hospital |
2023-07-25 | PHASE2 |
| NCT06022003 | RECRUITING | AML, Adult; Refractory AML; Relapsed Adult AML; FLT3-TKD Mutation; FLT3-ITD |
French Innovative Leukemia Organisation |
2024-01-13 | PHASE2 |
| NCT06561880 | RECRUITING | FLT3 Gene Mutation; AML |
Institute of Hematology & Blood Diseases Hospital, China |
2024-10-08 | PHASE1; PHASE2 |
| NCT05546580 | ACTIVE_NOT_RECRUITING | Acute Myeloid Leukemia, in Relapse; Acute Myeloid Leukemia Refractory |
Oryzon Genomics S.A. |
2022-11-14 | PHASE1 |
| NCT04027309 | ACTIVE_NOT_RECRUITING | Acute Myeloid Leukemia; Myelodysplastic Syndrome With Excess Blasts-2 |
Stichting Hemato-Oncologie voor Volwassenen Nederland |
2019-12-20 | PHASE3 |
| NCT04240002 | TERMINATED | Acute Myeloid Leukemia (AML); Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD) |
Astellas Pharma Global Development, Inc. |
2020-09-04 | PHASE1; PHASE2 |
| NCT05279859 | WITHDRAWN | Acute Myeloid Leukemia |
Erasca, Inc. |
2022-03-15 | PHASE1; PHASE2 |
| NCT05028751 | TERMINATED | Acute Myeloid Leukemia; Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia |
Kronos Bio |
2022-08-05 | PHASE1; PHASE2 |
| NCT05177731 | ACTIVE_NOT_RECRUITING | AML, Adult; Chemotherapy Effect |
Chen Suning |
2022-03-01 | PHASE3 |
| NCT06022003 | Recruiting | AML Adult|Refractory AML|Relapsed Adult AML|FLT3-TKD Mutation|FLT3-ITD |
French Innovative Leukemia Organisation|Acute Leukemia French Association |
2024-01-13 | Phase 2 |
| NCT03182244 | ACTIVE_NOT_RECRUITING | AML With FLT3 Mutation |
Astellas Pharma Inc |
2017-10-25 | PHASE3 |
| NCT04655391 | WITHDRAWN | Recurrent Acute Myeloid Leukemia |
City of Hope Medical Center |
2022-06-25 | PHASE1 |
| NCT04336982 | TERMINATED | Leukemia, Myeloid, Acute |
Celgene |
2020-08-05 | PHASE1 |
| NCT03836209 | COMPLETED | Acute Myeloid Leukemia |
PrECOG, LLC. |
2019-12-06 | PHASE2 |
| NCT02752035 | COMPLETED | Acute Myeloid Leukemia (AML); Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation |
Astellas Pharma Global Development, Inc. |
2016-08-01 | PHASE3 |
| NCT02997202 | COMPLETED | Acute Myeloid Leukemia |
Astellas Pharma Global Development, Inc. |
2017-08-16 | PHASE3 |
| NCT05520567 | Recruiting | Acute Myeloid Leukemia (AML)|FLT3-mutated Acute Myeloid Leukemia |
Astellas Pharma Global Development Inc.|Astellas Pharma Inc |
2023-01-27 | Phase 1|Phase 2 |
| NCT04699877 | COMPLETED | Renal Impaired; Gilteritinib; Normal Renal Function; Pharmacokinetics of ASP2215 |
Astellas Pharma Global Development, Inc. |
2021-01-28 | PHASE1 |
| NCT05791890 | Active not recruiting | Acute Myeloid Leukemia |
University of Rome Tor Vergata |
2022-05-31 | -- |
| NCT03625505 | COMPLETED | Acute Myeloid Leukemia (AML) |
AbbVie |
2018-10-18 | PHASE1 |
| NCT02310321 | COMPLETED | Acute Myeloid Leukemia; FLT3-mutated Acute Myeloid Leukemia |
Astellas Pharma Inc |
2015-02-26 | PHASE1; PHASE2 |
| NCT02236013 | COMPLETED | Acute Myeloid Leukemia |
Astellas Pharma Global Development, Inc. |
2015-01-07 | PHASE1 |
| NCT02927262 | COMPLETED | Acute Myeloid Leukemia (AML); Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation |
Astellas Pharma Global Development, Inc. |
2017-01-10 | PHASE2 |
| NCT03730012 | COMPLETED | Acute Myeloid Leukemia (AML); Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation |
Astellas Pharma Global Development, Inc. |
2019-06-19 | PHASE1; PHASE2 |
| NCT02561455 | COMPLETED | Advanced Solid Tumors; Acute Myeloid Leukemia |
Astellas Pharma Global Development, Inc. |
2016-05-03 | PHASE1; PHASE2 |
| NCT03964038 | COMPLETED | Healthy Volunteer |
Astellas Pharma Global Development, Inc. |
2019-05-21 | PHASE1 |
| NCT02421939 | COMPLETED | Leukemia, Acute Myeloid (AML) |
Astellas Pharma Global Development, Inc. |
2015-10-20 | PHASE3 |
| NCT02014558 | COMPLETED | Acute Myeloid Leukemia |
Astellas Pharma Global Development, Inc. |
2013-10-09 | PHASE1; PHASE2 |
| NCT02456883 | COMPLETED | Advanced Solid Tumors; Pharmacokinetics of 14C-labeled Gilteritinib |
Astellas Pharma Global Development, Inc. |
2016-03-04 | PHASE1 |
| NCT02495233 | TERMINATED | Non-Small-Cell Lung Cancer |
Astellas Pharma Global Development, Inc. |
2015-09-08 | PHASE1; PHASE2 |
| NCT02181660 | COMPLETED | Acute Myeloid Leukemia (AML) |
Astellas Pharma Inc |
2014-06-16 | PHASE1 |
| NCT02571816 | COMPLETED | Hepatic Impairment; Healthy |
Astellas Pharma Global Development, Inc. |
2015-10-23 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-09-03)
Check the
ASP2215 (Gilteritinib)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- ASP2215 (Gilteritinib) Mechanism of Action: FLT3 Inhibition in Leukemic Blast Cells Research
- ASP2215 (Gilteritinib) Working Concentration | Cell Culture | Treatment
- ASP2215 (Gilteritinib) Solubility in DMSO
- ASP2215 (Gilteritinib) Stock Solution
- ASP2215 (Gilteritinib) Storage
- ASP2215 (Gilteritinib) Stability
- ASP2215 (Gilteritinib) Combination Database
- ASP2215 (Gilteritinib) Molecular Weight
- ASP2215 (Gilteritinib) SMILES
- ASP2215 (Gilteritinib) CAS Number
- ASP2215 (Gilteritinib) Chemical Structure (2D and 3D)
- ASP2215 (Gilteritinib) IC50 for Cell-based and Cell-free Assays
- ASP2215 (Gilteritinib) Sigma (AMBH324AB971)? Try a better option.
- ASP2215 (Gilteritinib) MedChemExpress (HY-12432)? Try a better option.
- ASP2215 (Gilteritinib) Cayman (21503)? Try a better option.
- ASP2215 (Gilteritinib) APExBIO (A4691)? Try a better option.
- ASP2215 (Gilteritinib) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.