Clinical Trials

Numerous clinical trials evaluate linoleic acid across diverse therapeutic conditions, including essential fatty acid deficiency, parenteral nutrition-associated liver disease, pediatric malnutrition, cystic fibrosis, diabetes mellitus, asthma, and obesity. These investigations span early phase 1 through phase 4 as well as unassigned trials, sponsored by academic institutions such as Karolinska Institutet and pharmaceutical sponsors including Fresenius Kabi and Fujian Shengdi Pharmaceutical Co. Ltd. Evaluating protocols such as pediatric fatty acid status and cystic fibrosis supplementation, the research landscape reflects a dynamic recruitment spectrum encompassing completed, active, and upcoming studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06361511 RECRUITING
Sarcopenia
Ohio State University
 2025-04-16
NCT04677946 NOT_YET_RECRUITING
Insomnia Type; Sleep Disorder
Ohio State University
 2027-12
NCT02841618 ACTIVE_NOT_RECRUITING
Healthy Adults
Ohio State University
 2016-01
NCT04677920 ACTIVE_NOT_RECRUITING
Healthy Adults
Ohio State University
 2020-09-07
NCT07287514 RECRUITING
Insulin Resistance; Metabolic Disease
Pontificia Universidad Catolica de Chile
 2025-05-13
NCT05920018 UNKNOWN
Multiple Sclerosis, Relapsing-Remitting
Universität Münster
 2023-10-02
NCT06719466 ACTIVE_NOT_RECRUITING
Obese; Stomach Diseases
Zhang Manna
 2024-09-01
NCT04531410 COMPLETED
Cystic Fibrosis
Karolinska Institutet
 2021-10-25
NCT06274788 Not yet recruiting
Parenteral Nutrition Associated Liver Disease (PNALD)|Essential Fatty Acid Deficiency|Malnutrition|Pediatric ALL
Fresenius Kabi
 2024-05-01 Phase 4
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
NCT05788588 Active not recruiting
Parenteral Nutrition
Fujian Shengdi Pharmaceutical Co. Ltd.
 2023-04-28 Phase 3
NCT04728399 UNKNOWN
Overweight or Obesity
Fangfang Zeng
 2021-05-14
NCT05242224 Recruiting
Growth Disorders|Malnutrition Fetal|Stunting|Development; Delayed Malnutrition|Nutrition Disorder Fetal|Maternal Nutritional Disorders Affecting Fetus or Newborn
Washington University School of Medicine|St. Louis Children''s Hospital|St. Louis University|Children''s Discovery Institute|Universidad San Francisco de Quito
 2022-01-05 Not Applicable
NCT02962128 COMPLETED
Fatty Acid-Gene Interactions
Wake Forest University Health Sciences
 2016-11-29
NCT04531137 UNKNOWN
Overweight and Obesity; Body Weight
Indonesia University
 2020-08-05
NCT02433977 COMPLETED
Asthma
Gladwin, Mark, MD
 2015-09 PHASE2
NCT03883880 TERMINATED
Diet, Food Choice, Taste
Purdue University
 2019-01-05
NCT03115775 COMPLETED
Protein
Washington University School of Medicine
 2017-05-12
NCT03915808 COMPLETED
Obesity; Adiposity
Jiaomei Yang
 2019-03-27
NCT01251887 COMPLETED
Weight Gain; Healthy Subjects; Obesity; Women
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2010-11-12
NCT04641494 COMPLETED
Obesity; Lung Functions; Inflammation; Lipid Disorder
University of Chester
 2016-11-11
NCT02629627 COMPLETED
Metabolic Syndrome
Centro Universitario de Ciencias de la Salud, Mexico
 2016-03 PHASE2
NCT03914404 COMPLETED
Diabetic Neuropathy
Chonbuk National University Hospital
 2016-01-26 PHASE4
NCT02753907 COMPLETED
Healthy Subjects
Yonsei University
 2015-06 PHASE3
NCT02063802 UNKNOWN
Obesity
Laboratorios Silanes S.A. de C.V.
 2012-08 PHASE2
NCT00908791 COMPLETED
Breast Cancer
Dartmouth-Hitchcock Medical Center
 2009-06 EARLY_PHASE1
NCT00951158 TERMINATED
Advanced Solid Tumors
Dartmouth-Hitchcock Medical Center
 2010-03 PHASE1
NCT01234636 COMPLETED
Cardiovascular Disease
University of Aberdeen
 2010-11
NCT00638196 TERMINATED
Multiple Sclerosis
University of Rochester
 2008-03 PHASE1
NCT00607945 COMPLETED
Type 2 Diabetes Mellitus
Ohio State University
 2008-01 PHASE1
NCT02028975 COMPLETED
Type 2 Diabetes or Obesity Without Diabetes
Centre Hospitalier Universitaire Dijon
 2010-05-11
NCT00883649 COMPLETED
Keratoconjunctivitis Sicca
Virginia Eye Consultants
 2008-09
NCT01752972 COMPLETED
Arsenical Keratosis
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2011-04
NCT00608400 COMPLETED
Healthy
McGill University
 2008-12 PHASE1
NCT02183922 COMPLETED
Insulin Resistance; Oxidative Stress; Lipid Profile; Blood Pressure; Anthropometric Measure
Universidade Federal do Rio de Janeiro
 2008-05
NCT01841645 COMPLETED
Dietary Modification; Inflammation; Body Composition, Beneficial
Alexandre Guedes Torres
 2009-07
NCT01099163 COMPLETED
Type 2 Diabetes Mellitus
Shahid Beheshti University of Medical Sciences
 2009-01
NCT01026506 COMPLETED
Allergic Bronchial Asthma
University of Jena
 2008-01
NCT00706745 COMPLETED
Atherosclerosis
UMC Utrecht
 2007-06 PHASE3
NCT00575991 COMPLETED
Overweight
University of Wisconsin, Madison
 2007-01
NCT01047280 COMPLETED
Body Weight; Body Composition; Hyperlipidemia; Inflammation; Oxidative Stress
University of Manitoba
 2006-11 PHASE1
NCT02529046 COMPLETED
Lipid Metabolism Disorders; Obesity
Universidade Estadual de Londrina
 2007-03
NCT01121471 COMPLETED
Diabetes Mellitus
Ohio State University
 2004-12
NCT00204932 COMPLETED
Obesity
University of Wisconsin, Madison
 2004-07 PHASE2
NCT00876356 COMPLETED
Asthma
University of British Columbia
 2002-05
NCT01621087 COMPLETED
Coronary Heart Disease
National Institutes of Health Clinical Center (CC)
 1966-02
NCT00347373 COMPLETED
Obesity
University of North Carolina
 2004-08
NCT00473902 COMPLETED
Sarcopenia
Hamilton Health Sciences Corporation
 2003-08
NCT00449462 COMPLETED
Healthy
Wageningen University
 2007-03

(data from https://clinicaltrials.gov, updated on 2026-04-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Linoleic acid is an essential polyunsaturated fatty acid that integrates into lipid bilayers and serves as a fundamental metabolic substrate for the enzymatic biosynthesis of arachidonic acid and downstream eicosanoid signaling molecules. By preserving cell membrane fluidity, receptor function, and systemic lipid homeostasis, linoleic acid prevents cellular structural dysfunction, providing clear therapeutic relevance in addressing essential fatty acid deficiency, pediatric malnutrition, and related metabolic 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>).

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