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)
Mechanism and Biochemical Profile
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>).