Isorhamnetin Clinical Trials

Size	Price	Qty
1mg	USD 107
5mg	USD 297

Clinical Trials

A completed clinical trial sponsored by an academic institution (University of Glasgow) evaluated healthy volunteers to examine how the endurance training status of athletes influences the bioavailability of flavanone compounds, including isorhamnetin. Conducted under an unassigned phase status (Phase Not Applicable), the study focused on baseline physiological parameters rather than disease intervention. Currently, the clinical research landscape for isorhamnetin remains restricted to foundational bioavailability research, with no ongoing or completed therapeutic efficacy trials registered.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02627547	Completed	Healthy	University of Glasgow	2013-09	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Isorhamnetin directly binds to and inhibits tyrosinase while scavenging reactive oxygen species, thereby suppressing downstream enzymatic melanin biosynthesis and reducing oxidative cellular stress. This antioxidant and enzymatic inhibitory activity underpins its clinical investigation in healthy human cohorts to evaluate its systemic bioavailability and metabolic profile.

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>).