Clinical Trials

Several completed clinical trials have evaluated the therapeutic application of octanoic acid in early-stage development, encompassing Phase 1 and Phase 1/Phase 2 designs sponsored by Cerecin and Osaka University. These investigations targeted Alzheimer Disease and Idiopathic Triglyceride Deposit Cardiomyovasculopathy. Having fully completed recruitment, these trials established baseline clinical pharmacokinetic, safety, and therapeutic data for the compound.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03971123 Completed
Alzheimer Disease
Cerecin
 2019-08-30 Phase 1
NCT02502578 Completed
Idiopathic Triglyceride Deposit Cardiomyovasculopathy
Osaka University
 2015-09 Phase 1|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Octanoic acid functions as a medium-chain fatty acid that undergoes mitochondrial beta-oxidation to generate acetyl-CoA and ketone bodies, thereby modulating intracellular lipid metabolism and oxidative phosphorylation pathways. By serving as a direct metabolic energy substrate and regulating triglyceride turnover, it enhances cellular bioenergetics and reduces aberrant lipid accumulation, offering therapeutic relevance for metabolic and neurodegenerative disorders such as Alzheimer Disease and Idiopathic Triglyceride Deposit Cardiomyovasculopathy.

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.