5,7-Dihydroxychromone Clinical Trials

Size	Price	Qty
5mg	USD 269
25mg	USD 807

Clinical Trials

Global registry records indicate a Phase 2 clinical trial sponsored by the pharmaceutical company Hoffmann-La Roche to evaluate safety and therapeutic efficacy in patients with acute ischemic stroke. However, the study recruitment status is currently listed as withdrawn. Consequently, there is no active recruitment or completed data available for this clinical program.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05399550	Withdrawn	Acute Ischemic Stroke	Hoffmann-La Roche	2022-06-22	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

5,7-Dihydroxychromone functions as a potent activator of nuclear factor erythroid 2-related factor 2 (Nrf2)/antioxidant response element (ARE) signaling alongside peroxisome proliferator-activated receptor (PPAR) and liver X receptor (LXR) pathways, downstream triggering transcription of cytoprotective enzymes and modulating cellular glucose and lipid homeostasis. By suppressing oxidative damage and promoting cell survival during hypoxic or metabolic stress, this mechanistic profile underlies its therapeutic relevance in conditions such as acute ischemic stroke and diabetic metabolic dysfunction.

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>).