Clinical Trials

Multiple clinical trials have evaluated the therapeutic potential, bioavailability, and physiological effects of ellagic acid across conditions including metabolic syndrome, selected cancers, HPV infection, muscular injury, cardiovascular risk, and menopause. Sponsored primarily by academic and governmental institutions, these early-stage (Phase 1 and 2) and nutritional intervention studies comprise completed protocols, active non-recruiting trials, and unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07182370 ACTIVE_NOT_RECRUITING
Menopause Related Conditions; Cardiovascular Risk
National Research Council, Spain
 2024-01-15
NCT04011618 UNKNOWN
Metabolic Syndrome
University of Guadalajara
 2019-09-17 PHASE2
NCT04958018 Completed
Muscular Injury
Appalachian State University
 2021-06-16 Not Applicable
NCT04066816 COMPLETED
Colo-rectal Cancer; Colon Cancer; Diet Habit
UConn Health
 2019-05-20
NCT05025189 Completed
Healthy
University of California Los Angeles|The California Table grape Commission
 2020-10-05 Not Applicable
NCT03713164 COMPLETED
Healthy
University of California, Los Angeles
 2018-02-22
NCT02263378 COMPLETED
HPV Infection
University of Messina
 2014-09
NCT02056496 Completed
Healthy
National Research Council Spain|Universidad Católica San Antonio de Murcia
 2014-01 Phase 1
NCT00455416 UNKNOWN
Follicular Lymphoma
Oslo University Hospital
 2007-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-09-19)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ellagic acid directly binds to and inhibits topoisomerase I and topoisomerase II, thereby disrupting essential DNA replication and repair machinery within proliferative cells. This targeted enzymatic inhibition suppresses biochemical pathways required for cell cycle progression and induces apoptotic cell death, underlying its relevance in clinical investigations for conditions such as colorectal cancer and follicular lymphoma.

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.