Clinical Trials

Several clinical trials lacking assigned phases evaluate the therapeutic application of taxifolin as a dietary supplement, both alone and in combination formulations, for conditions including antioxidative stress, cold, influenza, aging, inflammation, and COVID-19. Sponsored by academic and research institutions such as the University of Southampton and Pirogov Russian National Research Medical University, these studies report varying recruitment statuses, ranging from active but not recruiting to unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05190432 ACTIVE_NOT_RECRUITING
Antioxidative Stress; Cold; Influenza; Aging; Inflammation
University of Southampton
2021-11-10
NCT04871802 UNKNOWN
Covid19
Pirogov Russian National Research Medical University
2021-05-10

(data from https://clinicaltrials.gov, updated on 2026-05-13)

Check the Taxifolin (Dihydroquercetin) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Taxifolin functions as a type I inhibitor of VEGFR-2 kinase and regulates gene expression through an antioxidant response element (ARE)-dependent mechanism, thereby blocking downstream angiogenic signaling and mitigating cellular oxidative stress. This modulation of kinase activity and oxidative response pathways underlies its prospective clinical utility in mitigating inflammation, cellular aging, and respiratory viral conditions including influenza and COVID-19.

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.