Clinical Trials

Multiple clinical trials are investigating Capric acid across Phase 2 and non-applicable phase designations, targeting postoperative pain reduction and physiological responses in healthy volunteers. These studies evaluate active drug delivery strategies as well as general physiological parameters. Sponsored by academic and research organizations—including Rutgers, The State University of New Jersey (alongside iPill Dispenser), and Escola Superior de Tecnologia da Saúde do Porto—the trials are currently listed as not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04414917 Not yet recruiting
Pain Postoperative
Rutgers The State University of New Jersey|iPill Dispenser
 2024-11 Phase 2
NCT05922189 Not yet recruiting
Healthy
Escola Superior de Tecnologia da Saúde do Porto
 2024-09-01 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Capric acid directly binds to and inhibits AMPA receptors while concurrently modulating peroxisome proliferator-activated receptors, thereby attenuating excitatory glutamatergic signaling and downstream biochemical cascades. This inhibition reduces neuronal excitability and cellular activation, ultimately leading to anticonvulsant and analgesic phenotypes relevant to postoperative pain management and neurological control.

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.