Clinical Trials

Several clinical trials lacking formal phase designations have evaluated eriocitrin for the management of pre-diabetes and insulin resistance. Sponsored by academic investigators, including Thais Cesar and São Paulo State University, these studies focused on reducing hyperglycemia, evaluating metabolic parameters, and examining intestinal microbiota alterations in pre-diabetic subjects. Most of these trials have completed recruitment, whereas a clinical trial was ultimately terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03928249 COMPLETED
Pre Diabetes
São Paulo State University
 2019-12-01
NCT03925909 TERMINATED
Pre Diabetes
São Paulo State University
 2019-05-01
NCT03215043 COMPLETED
Pre Diabetes
Thais Cesar
 2017-07-02

(data from https://clinicaltrials.gov, updated on 2020-10-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Eriocitrin functions as an antioxidant flavone glycoside that scavenges reactive oxygen species and suppresses downstream oxidative and inflammatory signaling pathways in metabolic tissues. By mitigating oxidative damage and promoting cellular redox balance, eriocitrin supports insulin sensitivity and glucose regulation in pre-diabetic conditions.

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.