Clinical Trials

Numerous clinical trials evaluate quizartinib across Early Phase 1 through Phase 3 protocols, primarily focusing on hematologic malignancies, such as FLT3-ITD-mutated acute myeloid leukemia, myelodysplastic syndromes, and pediatric myeloid cancers, as well as pharmacokinetic assessments in healthy subjects. Sponsored by pharmaceutical entities, academic medical centers, and cooperative pediatric groups, these studies currently encompass recruiting, active, completed, and terminated statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06578247 ACTIVE_NOT_RECRUITING
Leukemia
Daiichi Sankyo
 2024-11-19 PHASE3
NCT05735184 RECRUITING
Acute Myeloid Leukemia; Mixed Lineage Leukemia Gene Mutation; Refractory AML; AML With Mutated NPM1; Acute Myeloid Leukemia Recurrent; Acute Myeloid Leukemia, in Relapse; NPM1 Mutation; KMT2Ar; Myeloid Sarcoma; Nucleophosmin 1-mutated Acute Myeloid Leukemia
Kura Oncology, Inc.
 2023-07-18 PHASE1
NCT07478991 RECRUITING
Acute Myeloid Leukemia, Adult
PETHEMA Foundation
 2026-07-02 PHASE3
NCT06769490 RECRUITING
Acute Myeloid Leukemia
M.D. Anderson Cancer Center
 2025-07-10 PHASE1
NCT06824168 RECRUITING
Acute Myeloid Leukemia; Leukemia
Daiichi Sankyo
 2025-07-18 PHASE2
NCT06262438 RECRUITING
Acute Myeloid Leukemia in Children
Princess Maxima Center for Pediatric Oncology
 2024-02-06 PHASE2
NCT03661307 RECRUITING
Acute Myeloid Leukemia; Myelodysplastic Syndrome; Recurrent Acute Myeloid Leukemia; Recurrent Myelodysplastic Syndrome; Refractory Acute Myeloid Leukemia
M.D. Anderson Cancer Center
 2018-10-31 PHASE1; PHASE2
NCT04128748 ACTIVE_NOT_RECRUITING
Acute Myeloid Leukemia; Blasts More Than 10 Percent of Bone Marrow Nucleated Cells; High Risk Myelodysplastic Syndrome; Recurrent Acute Myeloid Leukemia; Recurrent Myelodysplastic Syndrome; Refractory Acute Myeloid Leukemia; Refractory Myelodysplastic Syndrome
M.D. Anderson Cancer Center
 2020-05-27 PHASE1; PHASE2
NCT04047641 RECRUITING
Acute Myeloid Leukemia; Blasts 20 Percent or More of Bone Marrow Nucleated Cells; High Risk Myelodysplastic Syndrome; Recurrent Acute Biphenotypic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent High Risk Myelodysplastic Syndrome; Refractory Acute Myeloid Leukemia; Refractory High Risk Myelodysplastic Syndrome
M.D. Anderson Cancer Center
 2019-10-22 PHASE1; PHASE2
NCT04493138 ACTIVE_NOT_RECRUITING
Chronic Myelomonocytic Leukemia; Myelodysplastic Syndrome; Myeloproliferative Neoplasm; Recurrent Chronic Myelomonocytic Leukemia; Recurrent Myelodysplastic Syndrome; Recurrent Myeloproliferative Neoplasm
M.D. Anderson Cancer Center
 2020-07-21 PHASE1; PHASE2
NCT07548710 RECRUITING
Acute Myeloid Leukemia
Ruijin Hospital
 2026-05-01 PHASE2
NCT03793478 ACTIVE_NOT_RECRUITING
Acute Myeloid Leukemia
Daiichi Sankyo
 2018-08-15 PHASE1; PHASE2
NCT06740799 RECRUITING
Hepatic Impairment
Daiichi Sankyo
 2024-09-30 PHASE1
NCT06772246 COMPLETED
Healthy Subjects
Daiichi Sankyo
 2024-10-24 PHASE1
NCT04676243 WITHDRAWN
Acute Myeloid Leukemia
University Hospital Heidelberg
 2022-05 PHASE3
NCT06740825 COMPLETED
Healthy Subjects
Daiichi Sankyo
 2024-10-29 PHASE1
NCT04687761 COMPLETED
Leukemia, Myeloid, Acute; De Novo; Age More 60yr
PETHEMA Foundation
 2020-11-04 PHASE1; PHASE2
NCT04107727 COMPLETED
Acute Myeloid Leukemia
PETHEMA Foundation
 2019-09-05 PHASE2
NCT04112589 UNKNOWN
Acute Myeloid Leukemia
PETHEMA Foundation
 2019-12-26 PHASE1; PHASE2
NCT03735875 TERMINATED
Acute Myeloid Leukemia With FLT3/ITD Mutation; Recurrent Acute Myeloid Leukemia; Refractory Acute Leukemia
M.D. Anderson Cancer Center
 2019-01-25 PHASE1; PHASE2
NCT01892371 COMPLETED
FLT3 Gene Mutation Negative; FLT3 Internal Tandem Duplication Positive; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Myelomonocytic Leukemia; Recurrent Myelodysplastic Syndrome; Refractory Acute Myeloid Leukemia; Refractory Chronic Myelomonocytic Leukemia; Refractory Myelodysplastic Syndrome
M.D. Anderson Cancer Center
 2013-11-12 PHASE1; PHASE2
NCT03989713 TERMINATED
AML According to WHO 2016 Classification (Except Acute Promyelocytic Leukemia) AND (Refractory to Induction Therapy OR Relapsed After First Line Treatment)
Prof. Dr. Richard F Schlenk
 2020-07-17 PHASE2
NCT03723681 COMPLETED
Acute Myeloid Leukemia (AML)
Daiichi Sankyo Co., Ltd.
 2018-11-05 PHASE1
NCT02668653 COMPLETED
Acute Myeloid Leukemia; Leukemia
Daiichi Sankyo
 2016-09-01 PHASE3
NCT04473664 COMPLETED
Hepatic Impairment; Moderate Impaired Hepatic Function
Daiichi Sankyo
 2020-09-22 PHASE1
NCT04796831 COMPLETED
Healthy Subjects
Daiichi Sankyo
 2021-04-26 PHASE1
NCT04209725 TERMINATED
Leukemia, Myeloid, Acute
SCRI Development Innovations, LLC
 2020-06-03 PHASE2
NCT03552029 TERMINATED
Acute Myeloid Leukemia
Daiichi Sankyo
 2018-12-12 PHASE1
NCT04459585 COMPLETED
Healthy Subjects; Drug-drug Interaction; Pharmacokinetics; Quizartinib
Daiichi Sankyo Co., Ltd.
 2020-08-28 EARLY_PHASE1
NCT04459598 COMPLETED
Healthy Subjects; Drug-drug Interaction; Pharmacokinetics; Quizartinib
Daiichi Sankyo Co., Ltd.
 2020-08-19 PHASE1
NCT03135054 UNKNOWN
AML; FLT3-ITD Mutation
The University of Hong Kong
 2017-10-01 PHASE2
NCT04473664 Completed
Hepatic Impairment|Moderate Impaired Hepatic Function
Daiichi Sankyo
 2020-09-22 Phase 1
NCT04459585 Completed
Healthy Subjects|Drug-drug Interaction|Pharmacokinetics|Quizartinib
Daiichi Sankyo Co. Ltd.|Daiichi Sankyo
 2020-08-28 Early Phase 1
NCT04459598 Completed
Healthy Subjects|Drug-drug Interaction|Pharmacokinetics|Quizartinib
Daiichi Sankyo Co. Ltd.|Daiichi Sankyo
 2020-08-19 Phase 1
NCT04209725 Terminated
Leukemia Myeloid Acute
SCRI Development Innovations LLC
 2020-06-03 Phase 2
NCT02675478 COMPLETED
Relapsed AML; Refractory AML
Daiichi Sankyo Co., Ltd.
 2016-02 PHASE1
NCT02984995 COMPLETED
Leukemia, Myeloid, Acute
Daiichi Sankyo Co., Ltd.
 2016-12-08 PHASE2
NCT02039726 COMPLETED
AML
Daiichi Sankyo
 2014-05 PHASE3
NCT02834390 COMPLETED
Acute Myeloid Leukemia
Daiichi Sankyo Co., Ltd.
 2016-08-12 PHASE1
NCT01565668 COMPLETED
Leukemia, Myeloid, Acute
Daiichi Sankyo
 2012-04 PHASE2
NCT01468467 COMPLETED
Leukemia, Myeloid, Acute
Daiichi Sankyo
 2012-04 PHASE1
NCT01390337 COMPLETED
Leukemia, Myeloid, Acute
Daiichi Sankyo
 2011-10 PHASE1
NCT01236144 COMPLETED
Acute Myeloid Leukaemia; High Risk Myelodysplastic Syndrome
Cardiff University
 2011-04 PHASE1; PHASE2
NCT01411267 COMPLETED
Lymphoblastic Leukemia, Acute, Childhood; Myelogenous Leukemia, Acute, Childhood
Therapeutic Advances in Childhood Leukemia Consortium
 2011-09-01 PHASE1
NCT00989261 COMPLETED
Acute Myeloid Leukemia
Daiichi Sankyo
 2009-11 PHASE2
NCT01049893 COMPLETED
Solid Tumors
Daiichi Sankyo
 2010-01 PHASE1
NCT00462761 COMPLETED
Acute Myeloid Leukemia; Leukemia; Myelodysplastic Syndrome; AML; MDS
Daiichi Sankyo
 2007-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-02)

Check the Quizartinib (AC220) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Quizartinib selectively binds to and inhibits the receptor tyrosine kinase FLT3, effectively blocking downstream oncogenic signal transduction and inducing apoptotic cell death in FLT3-dependent cell lines. This targeted inhibition suppresses leukemic cell proliferation, providing a clear biochemical rationale for its evaluation in clinical trials targeting acute myeloid leukemia and related hematologic malignancies harboring FLT3 mutations.

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>).

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Note: Technical data last updated: Sep 1, 2026.