Clinical Trials
Multiple clinical trials evaluate palmitoleic acid across conditions including metabolic disorders (prediabetes, insulin resistance, overweight, and obesity), inflammatory bowel disease, early breast cancer, and pressure ulcer prevention. Spanning early phase 1, phase 2, phase 4, and unassigned phases, these studies encompass completed, actively recruiting, enrolling by invitation, and active not recruiting recruitment stages. Sponsorship is driven by academic medical centers, national research institutes, and biotechnology companies, such as Brigham and Women's Hospital, Eli Lilly and Company, and Tersus Life Sciences LLC.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07417696 | NOT_YET_RECRUITING | Crohn's Disease |
Chinese Medical Association |
2026-04-01 | PHASE4 |
| NCT03372733 | RECRUITING | Cardiovascular Disease |
National Heart, Lung, and Blood Institute (NHLBI) |
2018-07-31 | PHASE2 |
| NCT05560971 | ACTIVE_NOT_RECRUITING | PreDiabetes; Insulin Resistance; Overweight; Obesity |
Brigham and Women's Hospital |
2022-11-01 | |
| NCT06928701 | RECRUITING | Early Breast Cancer; Neoadjuvant Treatment |
University of Eastern Piedmont |
2024-09-01 | |
| NCT07547254 | ENROLLING_BY_INVITATION | Pressure Ulcer Prevention |
Ruijin Hospital |
2025-12-01 | |
| 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 |
| NCT03625427 | COMPLETED | Chronic Inflammation; Overweight |
University of North Carolina, Chapel Hill |
2019-09-26 | |
| NCT05560971 | Recruiting | PreDiabetes|Insulin Resistance|Overweight|Obesity |
Brigham and Women''s Hospital|Tersus Life Sciences LLC |
2022-11-01 | Not Applicable |
| NCT04124042 | Completed | Osteoarthritis Knee |
Xalud Therapeutics Inc. |
2020-02-14 | Phase 2 |
| NCT03305809 | Completed | Lewy Body Dementia |
Eli Lilly and Company |
2017-11-09 | Phase 2 |
| NCT02682849 | Completed | Retained Blood Syndrome |
John M. Stulak|Mayo Clinic |
2016-05-10 | -- |
| NCT01771224 | UNKNOWN | Inflammatory Bowel Disease; Ulcerative Colitis |
National Institute of Medical Sciences and Nutrition, Salvador Zubiran |
2013-01 | EARLY_PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-02-18)
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>).