Pipecolic acid Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Multiple completed clinical trials have evaluated pipecolic acid under non-applicable phase designations, focusing on healthy individuals and patients with pyridoxine-dependent epilepsy. A clinical trial sponsored by Chalmers University of Technology investigated dose-response relationships of dietary biomarkers in healthy cohorts. Additionally, a clinical trial sponsored by Vitaflo International Ltd in collaboration with Radboud University Medical Center and Great Ormond Street Hospital for Children NHS Foundation Trust assessed specialized dietary management in pyridoxine-dependent epilepsy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05073523	Completed	Healthy	Chalmers University of Technology	2021-09-27	Not Applicable
NCT04672226	Completed	Pyridoxine Dependant Epilepsy	Vitaflo International Ltd\|Radboud University Medical Center\|Great Ormond Street Hospital for Children NHS Foundation Trust	2021-06-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pipecolic acid functions as a key lysine catabolite that modulates metabolic and neurotransmitter signaling networks in human physiological fluids including plasma and cerebrospinal fluid. Altered homeostasis of this metabolite disrupts neurochemical balance, rendering its quantification clinically relevant as a biomarker for assessing dietary metabolic responses and guiding intervention in pyridoxine-dependent epilepsy.

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>).