Numerous clinical trials evaluate arachidonic acid across diverse therapeutic and nutritional applications, spanning Phase 1 through Phase 4 interventional and observational studies. Sponsored by academic institutions such as Memorial Sloan Kettering Cancer Center and industrial partners like Fresenius Kabi, these protocols investigate conditions including essential fatty acid deficiency, parenteral nutrition-associated liver disease, infant nutritional requirements, coronary artery disease, and head and neck squamous cell carcinoma. Ranging from completed to active recruitment, trials evaluate interventions such as infant supplementation, intravenous lipid formulations, and cardiovascular modulation.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05380401 | RECRUITING | Premature |
The University of Texas Health Science Center at San Antonio |
2023-03-09 | |
| NCT06827873 | NOT_YET_RECRUITING | Influenza Vaccine Response |
Tsinghua University |
2025-02 | |
| NCT06366893 | UNKNOWN | Infant, Premature, Diseases |
Hospital Universitari Vall d'Hebron Research Institute |
2024-03-04 | |
| NCT05191823 | ACTIVE_NOT_RECRUITING | Preterm Birth; Child Development |
Sarah Keim |
2021-12-01 | |
| NCT06274788 | Not yet recruiting | Parenteral Nutrition Associated Liver Disease (PNALD)|Essential Fatty Acid Deficiency|Malnutrition|Pediatric ALL |
Fresenius Kabi |
2024-05-01 | Phase 4 |
| NCT05987384 | COMPLETED | Rabies Vaccination Reaction |
Tsinghua University |
2023-05-03 | |
| NCT05788588 | Active not recruiting | Parenteral Nutrition |
Fujian Shengdi Pharmaceutical Co. Ltd. |
2023-04-28 | Phase 3 |
| NCT04827251 | Recruiting | Coronary Artery Disease |
University of Sao Paulo|Fundação de Amparo à Pesquisa do Estado de São Paulo |
2022-09-01 | Not Applicable |
| NCT05542147 | Recruiting | Type 2 Diabetes|Cardiovascular Diseases|Pharmacogenomic Drug Interaction |
Mario Luca Morieri|University Hospital Padova |
2022-07-03 | Not Applicable |
| NCT01576783 | COMPLETED | Preterm Birth; Child Development |
Sarah Keim |
2012-04-26 | PHASE4 |
| NCT00982462 | COMPLETED | Infant Development |
Retina Foundation of the Southwest |
2011-01-20 | |
| NCT02219412 | COMPLETED | Coronary Heart Disease |
Yong Huo |
2014-08 | PHASE4 |
| NCT02503020 | COMPLETED | Impaired Psychomotor Development |
Health Research Institute of Santiago |
2011-07 | PHASE2 |
| NCT02092857 | COMPLETED | Focus: Nutritional Requirements for Infants |
University of Alberta |
2009-12 | PHASE1 |
| NCT02144389 | COMPLETED | Schistosomiasis; Bilharzia |
dsm-firmenich Switzerland AG |
2013-01 | |
| NCT01021215 | COMPLETED | Tobacco Use Disorder |
National Cancer Institute (NCI) |
2010-05 | PHASE1; PHASE2 |
| NCT01154894 | COMPLETED | Autism Spectrum Disorders |
Ashiya University |
2009-02 | |
| NCT01300130 | COMPLETED | Prematurity of Fetus |
Ludwig-Maximilians - University of Munich |
1995-06 |
(data from https://clinicaltrials.gov, updated on 2025-09-24)
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>).