Clinical Trials

A completed clinical trial sponsored by an academic institution, Tufts University, investigated the metabolic effects of an enzymatically modified form of isoquercitrin in overweight and obese individuals. Conducted without an assigned clinical phase, the study focused on weight management to evaluate the safety and body fat-reducing efficacy of the compound. Overall, clinical research on isoquercitrin remains limited, primarily addressing nutritional and metabolic health applications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02818699 COMPLETED
Overweight; Obese
Tufts University
2016-08-01

(data from https://clinicaltrials.gov, updated on 2025-12-10)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Isoquercitrin acts as a flavonoid inhibitor of the Wnt/β-catenin signaling pathway downstream of β-catenin nuclear translocation, suppressing β-catenin-mediated transcriptional activation and regulating downstream genes involved in cell differentiation and metabolic processes. Through this modulation of Wnt/β-catenin signaling and subsequent attenuation of adipogenesis, isoquercitrin reduces intracellular fat accumulation, establishing a mechanistic basis for its clinical investigation in overweight and obese populations.

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>).

Note: Technical data last updated: Sep 1, 2026.