Clinical Trials

Multiple clinical trials evaluate ferulic acid across Phase 1, Phase 2, and non-phase interventional protocols in healthy cohorts—including healthy males and elderly populations—as well as in patients with periodontitis and behavioral and psychiatric symptoms of dementia. Sponsored by academic universities, research councils, and commercial entities, these studies encompass various recruitment statuses, including completed, active not recruiting, unknown, and not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07801521 NOT_YET_RECRUITING
Healthy Elder People
Oregon Health and Science University
2026-11-15
NCT07404072 ACTIVE_NOT_RECRUITING
Periodontitis
Salah Awad Alanazi
2025-05-16 PHASE1; PHASE2
NCT03451760 UNKNOWN
Behavioral and Psychiatric Symptoms of Dementia
Glovia Co., Ltd.
2018-09 PHASE2
NCT02731755 Completed
Healthy
University of Reading|Biotechnology and Biological Sciences Research Council|Rothamsted Research|PepsiCo Global R&D|University of Roehampton
2016-01 Not Applicable
NCT00777543 COMPLETED
Healthy Males
Maastricht University Medical Center
2008-11

(data from https://clinicaltrials.gov, updated on 2026-09-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ferulic acid functions as a fibroblast growth factor receptor (FGFR) inhibitor targeting FGFR1 and FGFR2 while actively scavenging reactive oxygen species, thereby blocking downstream receptor signaling pathways and suppressing cellular oxidative stress. This dual inhibition of growth factor signaling and oxidative cellular damage provides the biological rationale for its clinical evaluation in mitigating periodontitis, behavioral and psychiatric symptoms of dementia, and vascular oxidative stress 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.