α-Linolenic acid Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Numerous Phase II through Phase IV clinical trials evaluate the therapeutic potential of alpha-linolenic acid across cardiovascular, metabolic, and critical care conditions, including hypertension, morbid obesity, atherosclerosis, diabetic neuropathy, parenteral nutrition-associated liver disease, and essential fatty acid deficiency. Sponsored by academic medical centers such as the University of Sao Paulo and Maastricht University Medical Center as well as pharmaceutical companies like Fresenius Kabi, these clinical trials range in status from completed and actively recruiting to withdrawn or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07392723	RECRUITING	Cognitive Dysfunction; Alzheimer Disease; Blood-Brain Barrier; Apolipoprotein E, Deficiency or Defect of; Brain Aging; Fatty Acids, Omega-3	Michal Schnaider Beeri, Ph.D.	2025-01-12	PHASE2
NCT06274788	Not yet recruiting	Parenteral Nutrition Associated Liver Disease (PNALD)\|Essential Fatty Acid Deficiency\|Malnutrition\|Pediatric ALL	Fresenius Kabi	2024-05-01	Phase 4
NCT05053347	COMPLETED	Elevated Blood Sugar	Huazhong University of Science and Technology	2022-07-01
NCT04481724	COMPLETED	Weight Trajectory	Virta Health	2020-07-22
NCT03040856	WITHDRAWN	Omega 3 Supplements During Pregnancy	Sheba Medical Center	2022-02-01
NCT02433977	COMPLETED	Asthma	Gladwin, Mark, MD	2015-09	PHASE2
NCT03558776	COMPLETED	Endogenous Conversion of Alpha Linolenic Acid	University of Jena	2018-03-13
NCT03914404	COMPLETED	Diabetic Neuropathy	Chonbuk National University Hospital	2016-01-26	PHASE4
NCT02243969	COMPLETED	Hypertension; Lipid Metabolism Disorders	Maastricht University Medical Center	2014-05
NCT02609295	COMPLETED	Hypercholesterolemia	Yonsei University	2015-02	PHASE3
NCT01768429	COMPLETED	Hyperglycemia	University of Eastern Finland	2012-10
NCT02410161	COMPLETED	Healthy	Université de Sherbrooke	2013-07
NCT00502021	UNKNOWN	Morbid Obesity; Atherosclerosis; Systemic Inflammation	University of Sao Paulo	2007-08	PHASE2
NCT00874536	COMPLETED	Attention Deficit Hyperactivity Disorder	Hadassah Medical Organization	2009-04
NCT03025620	COMPLETED	Cardiovascular Diseases; Inflammation; Metabolism Disorder, Lipid	Assistance Publique - Hôpitaux de Paris	2006-11
NCT01634776	COMPLETED	Effect of Fatty Acids on Memory Performance of Toddlers	University of North Carolina, Chapel Hill	2009-02
NCT01179971	COMPLETED	Rheumatoid Arthritis	Charite University, Berlin, Germany	2008-12	PHASE2
NCT00967733	COMPLETED	Cardiovascular Disease	Harvard School of Public Health (HSPH)	2009-02
NCT00609180	TERMINATED	Respiratory Distress Syndrome, Adult	National Heart, Lung, and Blood Institute (NHLBI)	2007-12	PHASE3
NCT00329680	COMPLETED	Sepsis; Severe Sepsis; Septic Shock	Fernandes Tavora Hospital	2007-06	PHASE4
NCT00465153	COMPLETED	Inflammation; Sarcopenia	University of Saskatchewan	2007-04	PHASE3
NCT00004420	COMPLETED	Juvenile Rheumatoid Arthritis	FDA Office of Orphan Products Development	1994-09
NCT00309439	UNKNOWN	Atrial Fibrillation; Diet Therapy; Prostate Cancer	University of Toronto		PHASE2

(data from https://clinicaltrials.gov, updated on 2026-02-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alpha-linolenic acid incorporates into cellular membranes and modulates the phosphoinositide 3-kinase (PI3K)/Akt signaling axis, thereby suppressing downstream pro-thrombotic and pro-inflammatory signaling cascades within vascular cells. By inhibiting hyperactive PI3K/Akt pathways and mitigating aberrant platelet aggregation, alpha-linolenic acid exerts anti-thrombotic and anti-arrhythmic effects that provide a mechanistic basis for its clinical investigation in cardiovascular and inflammatory disorders such as atherosclerosis and hypertension.

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>).