Clinical Trials

Multiple clinical trials evaluate Eicosapentaenoic acid ethyl ester in gastrointestinal oncology and microbiome modulation, specifically assessing its therapeutic and preventive potential in colorectal adenoma, colon cancer, and colorectal cancer in patients undergoing endoscopic surgery. Encompassing Phase 1/Phase 2 and Phase 2 investigations, these studies are sponsored by Massachusetts General Hospital, the National Institutes of Health, and the Harvard School of Public Health. Recruitment statuses include both completed and prematurely withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04216251 Completed
Colorectal Adenoma|Colorectal Cancer|Endoscopic Surgery|Eicosapentaenoic Acid|Gastrointestinal Microbiome
Massachusetts General Hospital|National Institutes of Health (NIH)
 2020-12-09 Phase 1|Phase 2
NCT03661047 Withdrawn
Colon Cancer
Massachusetts General Hospital|Harvard School of Public Health (HSPH)
 2019-11-30 Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Eicosapentaenoic acid ethyl ester acts as an omega-3 fatty acid lipid regulator that incorporates into cellular membranes and alters lipid synthesis pathways, thereby reducing serum triglyceride levels without elevating low-density lipoprotein cholesterol. This attenuation of pro-inflammatory lipid signaling and metabolic dysregulation provides a mechanistic basis for its clinical evaluation in colorectal adenoma and colon cancer management.

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.