Clinical Trials

Multiple clinical trials evaluate the biological effects and therapeutic potential of naringenin across diverse health indications, including hepatitis C infection, metabolic syndrome, vascular compliance, bone fractures, and general safety and pharmacokinetics. Predominantly sponsored by academic and medical research institutions such as Massachusetts General Hospital and Pennington Biomedical Research Center, these Phase 1, Early Phase 1, and unclassified phase studies encompass recruitment statuses ranging from completed to active and actively recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06612762 RECRUITING
Bone Fractures
Shahid Beheshti University of Medical Sciences
2024-11-03
NCT05073523 Completed
Healthy
Chalmers University of Technology
2021-09-27 Not Applicable
NCT04697355 COMPLETED
Energy Expenditure; Safety Issues; Glucose Metabolism
Pennington Biomedical Research Center
2021-04-19
NCT04731987 Active not recruiting
Metabolic Syndrome|Vascular Compliance|Predisposition to Cardiovascular Disease
University Hospital Clermont-Ferrand|UMR 1019 Unité de Nutrition Humaine INRAE Auvergne-Rhône Alpes Center|Department of Beverage Research Chair of analysis and technology of plant-based foods Geisenheim University|European Fruit Juice Association (AIJN)
2021-02-24 Not Applicable
NCT03582553 COMPLETED
Safety Issues; Pharmacokinetics
Pennington Biomedical Research Center
2018-05-25 EARLY_PHASE1
NCT03582553 Completed
Safety Issues|Pharmacokinetics
Pennington Biomedical Research Center|Louisiana Clinical and Translational Science Center
2018-05-25 Early Phase 1
NCT03032861 Completed
Intestinal Diseases
São Paulo State University
2016-09 Not Applicable
NCT02380144 Unknown status
Healthy
University of Hohenheim
2014-01 Not Applicable
NCT01091077 COMPLETED
Hepatitis C Virus; HCV Infection; Chronic HCV; Hepatitis C
Massachusetts General Hospital
2009-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Naringenin binds to cellular oxidative targets and inhibits cytochrome P450 isoforms, particularly CYP1A2, which modulates hepatic xenobiotic metabolism and reduces reactive oxygen species production to prevent oxidative DNA damage. This antioxidant and enzymatic inhibitory activity contributes to anti-inflammatory signaling and altered metabolic pathways, providing potential clinical utility in managing metabolic syndrome, glucose dysregulation, and viral infections such as hepatitis C.

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.