Clinical Trials

Several clinical trials evaluate conditions associated with Hexadecanedioic acid and related formulations, investigating diverse areas including patient adherence, infant weight gain, prostate cancer, gut health, and dietary body weight changes. Sponsored by academic medical centers, government entities such as the National Cancer Institute, and industry research organizations, these studies are classified as Phase "Not Applicable" and range in recruitment status from completed to active, not recruiting, and recruiting. Collectively, these investigations represent a multifaceted evaluation of metabolic, nutritional, and oncological outcomes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
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
NCT04541095 Recruiting
Weight Gain
Ospedali Riuniti Ancona|Istituto di Ricerca Pediatrica Città della Speranza|Bunge Loders Croklaan
 2023-01-16 Not Applicable
NCT03665922 Active not recruiting
Prostate Cancer
University of Pittsburgh|National Cancer Institute (NCI)
 2019-05-01 Not Applicable
NCT05791370 Completed
Diet|Healthy
Malaysia Palm Oil Board|Universiti Putra Malaysia
 2019-01-01 Not Applicable
NCT04832217 Completed
Body Weight Changes|Habits Diet|Habit Food|Life Change Events
Universidad de Zaragoza
 2019-01-20 Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hexadecanedioic acid functions as a long-chain dicarboxylic acid that integrates into cellular lipid pathways, thereby disrupting aberrant lipid metabolism and downstream cell-signaling cascades required for tumor survival. This inhibition of metabolic signaling suppresses pathological cellular proliferation, contributing to its antitumor activity and therapeutic potential in clinical research areas such as prostate cancer and metabolic health.

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.