Flumatinib (HH-GV-678) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 447

Clinical Trials

Numerous clinical trials evaluate flumatinib across Phase 1 through Phase 4 studies, primarily focusing on chronic and accelerated phase chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Sponsored by pharmaceutical entities such as Jiangsu Hansoh Pharmaceutical Co., Ltd. alongside academic medical centers, these trials display varied recruitment statuses, including active recruiting, completed, and terminated. Key investigation themes include evaluating first-line therapeutic efficacy, safety during treatment transitions, and comparative outcomes against standard tyrosine kinase inhibitors like imatinib.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05367765	NOT_YET_RECRUITING	CML, Chronic Phase	Jiangsu Hansoh Pharmaceutical Co., Ltd.	2022-04-30	PHASE4
NCT06530810	NOT_YET_RECRUITING	Chronic Myelogenous Leukemia; CML Chronic Phase; CML Accelerated Phase	Jiangsu Hansoh Pharmaceutical Co., Ltd.	2024-07-31	PHASE1
NCT05433532	COMPLETED	Philadelphia Chromosome; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Chronic Myeloid Leukemia; Mixed Phenotype Acute Leukemia	The First Affiliated Hospital of Soochow University	2022-05-01	PHASE2
NCT04677439	UNKNOWN	Flumatinib; Chronic Myeloid Leukemia, Chronic Phase; Imatinib	Shenzhen Second People's Hospital	2021-01-01	PHASE4
NCT04933526	UNKNOWN	Chronic Myeloid Leukemia in Chronic Phase	Shenzhen Second People's Hospital	2021-07-01	PHASE4
NCT05071482	TERMINATED	Acute Leukemia	Institute of Hematology & Blood Diseases Hospital, China	2021-09-16	PHASE4
NCT04375683	UNKNOWN	Acute Lymphocytic Leukemia, Adult B-Cell; BCR-ABL1 Fusion Protein Expression	Zhongda Hospital	2020-03-01	PHASE3
NCT05353205	UNKNOWN	CML, Chronic Phase	Jiangsu Hansoh Pharmaceutical Co., Ltd.	2021-11-23	PHASE4
NCT04933526	Recruiting	Chronic Myeloid Leukemia in Chronic Phase	Shenzhen Second People''s Hospital	2021-07-01	Phase 4
NCT04677439	Unknown status	Flumatinib\|Chronic Myeloid Leukemia Chronic Phase\|Imatinib	Shenzhen Second People''s Hospital\|Hainan General Hospital\|Sanya Central Hospital\|First Affiliated Hospital of Shantou University Medical Collegeity\|Peking University Shenzhen Hospital\|Dongguan People''s Hospital	2021-01-01	Phase 4
NCT02204644	COMPLETED	CML, CML-CP,MMR,TKI	Jiangsu Hansoh Pharmaceutical Co., Ltd.	2014-06	PHASE3
NCT02511340	UNKNOWN	Chronic Myelogenous Leukemia	Jiangsu Hansoh Pharmaceutical Co., Ltd.	2013-01	PHASE2
NCT01503502	UNKNOWN	Myelogenous Leukemia, Chronic	Jiangsu HengRui Medicine Co., Ltd.	2011-08	PHASE2

(data from https://clinicaltrials.gov, updated on 2022-05-10)

Check the Flumatinib (HH-GV-678) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Flumatinib selectively binds to the ATP-binding site of Bcr-Abl, c-Abl, PDGFR, and c-Kit receptor tyrosine kinases, blocking downstream autophosphorylation and oncogenic signaling cascades. This enzymatic inhibition suppresses leukemic cell proliferation and induces apoptosis, providing therapeutic efficacy in Bcr-Abl-driven malignancies such as chronic myeloid leukemia and acute lymphoblastic leukemia.

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>).