Clinical Trials

Several Phase I clinical trials sponsored by Kyowa Kirin Inc. or its corporate affiliates evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of KW-2449 in patient populations with hematologic malignancies, including acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, and myelodysplastic syndromes. All recorded trials for this compound have been terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00779480 TERMINATED
Acute Myelogenous Leukemia (AML)
Kyowa Kirin Co., Ltd.
 2009-01 PHASE1
NCT00346632 TERMINATED
Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndromes; Chronic Myelogenous Leukemia
Kyowa Kirin, Inc.
 2006-06 PHASE1
NCT00346632 Terminated
Acute Myelogenous Leukemia|Acute Lymphoblastic Leukemia|Myelodysplastic Syndromes|Chronic Myelogenous Leukemia
Kyowa Kirin Inc.
 2006-06 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-04-25)

Check the KW-2449 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

KW-2449 is a multi-targeted kinase inhibitor that selectively binds FLT3, ABL, ABL-T315I, and Aurora kinases, thereby blocking downstream oncogenic phosphorylation cascades and suppressing leukemic cell growth. This targeted multi-kinase inhibition directly addresses key oncogenic drivers in hematologic malignancies, providing the mechanistic rationale for evaluating KW-2449 in clinical trials for acute myelogenous leukemia, chronic myelogenous leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes.

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.