Clinical Trials
Multiple clinical trials have evaluated γ-Linolenic acid and associated lipid formulations across Phase 2, Phase 4, and unassigned phases for hyperlipidemia, relapsing-remitting multiple sclerosis, and adherence biomarkers. Academic and government entities, including the University of Mississippi Medical Center and the National Center for Complementary and Integrative Health, sponsored a completed biomarker study. Additionally, industry sponsors Takeda and Boston Scientific Corporation conducted a completed Phase 4 trial examining vascular endothelial function and a terminated Phase 2 trial evaluating structured lipid formulations, respectively.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05556967 | Completed | Adherence Patient |
University of Mississippi Medical Center|University of Mississippi National Center for Natural Products Research|National Center for Complementary and Integrative Health (NCCIH) |
2023-08-09 | Not Applicable |
| NCT02824432 | Completed | Hyperlipidemia |
Takeda |
2016-08-04 | Phase 4 |
| NCT01037907 | Terminated | Relapsing Remitting Multiple Sclerosis |
Boston Scientific Corporation |
2009-11 | Phase 2 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
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>).