Clinical Trials

Multiple clinical trials evaluate the natural antioxidant compound tyrosol and its formulations in healthy volunteers and populations with cardiovascular disease to investigate its bioavailability and potential therapeutic effects. Categorized as non-phase interventions, these studies have recruitment statuses listed as completed or active, not recruiting. They are sponsored by academic and clinical institutions—including Anglia Ruskin University, Parc de Salut Mar, and Instituto Kurz—alongside industrial collaborator Fattoria La Vialla.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06285682 Active not recruiting
Healthy
Anglia Ruskin University|Fattoria La Vialla|Instituto Kurz
2024-02-03 Not Applicable
NCT02783989 Completed
Cardiovascular Disease
Parc de Salut Mar
2016-01-20 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tyrosol exerts antioxidant and anti-inflammatory activity by scavenging reactive oxygen species and suppressing nuclear factor kappa B (NF-κB) activation, which consequently attenuates the expression of downstream pro-inflammatory cytokines. This reduction in oxidative stress and cellular inflammation supports its evaluation in clinical trials assessing vascular health in cardiovascular disease as well as polyphenol bioavailability in healthy individuals.

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.