Pyridoxal 5-phosphate monohydrate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A completed clinical trial evaluated the feasibility and dietary management utility of a specialized medical food formulation containing pyridoxal 5-phosphate monohydrate in patients with pyridoxine-dependent epilepsy. Conducted as a phase-not-applicable feasibility study, the research was supported by a collaboration between industry and academic medical centers, including Vitaflo International Ltd, Radboud University Medical Center, and Great Ormond Street Hospital for Children NHS Foundation Trust. Overall, this reflects a targeted clinical focus on metabolic epilepsy interventions utilizing active vitamin B6 derivative formulations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
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 Pyridoxal 5-phosphate monohydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pyridoxal 5-phosphate monohydrate functions as an essential enzymatic cofactor that binds to pyridoxal phosphate-dependent enzymes, facilitating critical transamination, decarboxylation, and racemization reactions in amino acid metabolism. By restoring functional coenzyme activity and normal neurotransmitter biosynthesis, this compound mitigates metabolic disruption and seizure susceptibility in patients with 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>).