Clinical Trials

Multiple clinical trials evaluate oleuropein across various health conditions, including muscular fatigue, COVID-19 respiratory infections, metabolic syndrome, abdominal obesity, knee joint discomfort, coronary artery disease, periodontitis, and healthy subjects, with formal trial phases designated as Not Applicable. Sponsored by corporate entities such as Société des Produits Nestlé alongside academic institutions and university medical centers, these studies encompass recruitment statuses ranging from completed and active but not recruiting to unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04520126 UNKNOWN
Coronary Artery Disease
University of Athens
 2020-12-01
NCT06673914 ACTIVE_NOT_RECRUITING
Metabolic Syndrome; Insulin Resistance; Obesity, Abdominal; Obesity
Atlas University
 2024-11-01
NCT05482373 UNKNOWN
Periodontitis
Jose Luis Quiles Morales
 2021-04-15
NCT05217433 COMPLETED
Muscular Fatigue
Société des Produits Nestlé (SPN)
 2021-11-04
NCT04873349 COMPLETED
Covid19; COVID-19 Respiratory Infection; Symptoms and Signs; COVID-19 Acute Bronchitis; Disseminated Intravascular Coagulation
Shimaa M. Abdelgawad
 2021-05-10
NCT05217433 Completed
Muscular Fatigue
Société des Produits Nestlé (SPN)|Maastricht University Medical Center
 2021-11-04 Not Applicable
NCT04328571 COMPLETED
Healthy Subjects
Société des Produits Nestlé (SPN)
 2020-02-10
NCT03072108 COMPLETED
Knee Discomfort; Knee Pain
Société des Produits Nestlé (SPN)
 2016-06-24

(data from https://clinicaltrials.gov, updated on 2024-05-29)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oleuropein directly binds to and inhibits peroxisome proliferator-activated receptor gamma (PPARγ) transcriptional activity while suppressing aromatase, thereby blocking downstream adipogenesis and pro-inflammatory signaling pathways. This inhibition promotes apoptosis and reduces oxidative cellular stress, offering a mechanistic basis for its clinical investigation in metabolic syndrome, obesity, coronary artery disease, and joint inflammation.

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>).

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