Clinical Trials

A clinical trial involving syringic acid was completed in healthy volunteers to evaluate physiological parameters, specifically gut microbiome modifications following dietary polyphenol intake. Conducted without a formal clinical phase designation, this pilot study was supported by academic and agricultural sponsors, including the University of California, Los Angeles, and the California Table Grape Commission. Ultimately, this early-stage effort demonstrates how natural phenolic compounds may modulate human microbiome composition and metabolic wellness.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05025189 Completed
Healthy
University of California Los Angeles|The California Table grape Commission
2020-10-05 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a naturally occurring phenolic compound, syringic acid directly scavenges reactive oxygen species and inhibits the formation of advanced glycation end-products, thereby suppressing downstream nuclear factor kappa B activation and pro-inflammatory cytokine expression. This attenuation of oxidative and glycative stress reduces cellular apoptosis and endothelial damage, providing a biochemical basis for evaluating its health-promoting and metabolic effects in healthy human subjects.

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.