HM43239 Clinical Trials

Size	Price	Qty
5mg	USD 159
100mg	USD 970

Clinical Trials

A clinical trial sponsored by Aptose Biosciences Inc. is actively recruiting patients to evaluate the investigational agent HM43239 in hematologic oncology. This Phase 1/2 study assesses the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in individuals with relapsed or refractory acute myeloid leukemia. By targeting mutant FLT3 pathways, the investigation seeks to establish the therapeutic activity and clinical feasibility of this compound in an advanced patient cohort.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03850574	Recruiting	Relapsed or Refractory Acute Myeloid Leukemia	Aptose Biosciences Inc.	2019-03-11	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the HM43239 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

HM43239 is a potent small-molecule inhibitor of FLT3 kinase that selectively binds to and inhibits both wild-type FLT3 and its activating mutations, including ITD, D835Y TKD, and ITD/TKD double mutants, thereby suppressing downstream oncogenic signaling pathways and promoting leukemic cell apoptosis. This selective biochemical inhibition halts leukemic proliferation, demonstrating therapeutic relevance for patients suffering from relapsed or refractory acute myeloid leukemia harboring FLT3 driver 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>).