4',5,7-Trimethoxyflavone Clinical Trials

Size	Price	Qty
5mg	USD 167
25mg	USD 509

Clinical Trials

Several clinical trials are evaluating therapeutic applications of this compound for diverse conditions, including chronic hepatitis B, acute leukemia, cardiovascular diseases, and acute migraine. Encompassing Phase 2 protocols as well as phase-unspecified or non-applicable studies, recruitment statuses range from actively recruiting to completed. Trial sponsors comprise both academic research institutions and pharmaceutical companies, including Allergan, the Ottawa Heart Institute Research Corporation, University Health Network Toronto, and Chongqing Medical University.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05755776	Recruiting	Chronic Hepatitis B	The Second Affiliated Hospital of Chongqing Medical University\|Jiangsu Hansoh Pharmaceutical Co. Ltd.	2023-03-01	--
NCT05236296	Recruiting	Leukemia Acute	University Health Network Toronto\|The Hospital for Sick Children	2022-04-12	Not Applicable
NCT04781504	Completed	Cardiovascular Diseases\|Coronary Heart Disease	Ottawa Heart Institute Research Corporation	2021-04-05	Not Applicable
NCT01657370	Completed	Migraine	Allergan	2012-08	Phase 2

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

Check the 4',5,7-Trimethoxyflavone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

4',5,7-Trimethoxyflavone induces cell death by upregulating the pro-apoptotic Bax/Bcl-xL expression ratio, leading to downstream caspase-3 activation, poly(ADP-ribose) polymerase degradation, and accumulation of cells in the sub-G1 phase with extensive DNA fragmentation. This cascade of apoptotic signaling drives cell death and targeted cytotoxicity, offering therapeutic relevance for oncological indications such as acute leukemia where induction of apoptosis in aberrant cells is critical.

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>).