Clinical Trials

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)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an essential polyunsaturated fatty acid, arachidonic acid serves as a primary substrate for cyclooxygenase, lipoxygenase, and cytochrome P450 enzymes, leading to the biosynthesis of bioactive eicosanoid mediators including prostaglandins, thromboxanes, and leukotrienes that regulate inflammatory signaling, vascular tone, and cell survival. These downstream lipid signaling networks modulate cellular immunity, platelet aggregation, and membrane integrity, providing the physiological rationale for supplementing arachidonic acid in parenteral nutrition formulations and assessing its impact on pediatric lipid deficiency and cardiovascular 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>).

Note: Technical data last updated: Sep 1, 2026.