Pyridoxine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials are evaluating pyridoxine for diverse metabolic, neurological, and cardiovascular conditions, such as pyridoxine-dependent epilepsy, ischemic stroke, type 2 diabetes mellitus, and vitamin deficiency. Sponsored primarily by academic, medical, and governmental entities—including University Hospital Angers, Barts & The London NHS Trust, and the German Federal Institute for Risk Assessment—these studies are either actively recruiting or not yet recruiting participants. Across these initiatives, trial phases are currently classified as unassigned or not applicable.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06323538	Not yet recruiting	Dietary Exposure\|Diabetes Mellitus Type 2\|Cardiovascular Diseases\|Bone Loss\|Sustainability\|Exposure\|Obesity\|Vitamin Deficiency\|Mineral Deficiency	German Federal Institute for Risk Assessment\|Max Rubner-Institut\|University of Bonn\|Research Institute for Plant-Based Nutrition\|University of Jena\|University of Regensburg\|Heidelberg University\|University of Vienna	2024-04-01	--
NCT06054347	Not yet recruiting	Pyridoxine-Dependent Epilepsy	University Hospital Angers	2023-11-01	--
NCT05474105	Recruiting	Ischemic Stroke	Barts & The London NHS Trust\|Queen Mary University of London\|Nutricia Research	2023-07-11	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pyridoxine serves as an essential precursor to pyridoxal 5'-phosphate, acting as an obligate cofactor for enzymes such as glutamic acid decarboxylase and GABA transaminase to regulate neurotransmitter synthesis and cellular amino acid metabolism. Restoration of these enzymatic pathways mitigates neurometabolic dysregulation, supporting its clinical application in addressing conditions such as pyridoxine-dependent epilepsy, ischemic stroke, and metabolic disorders associated with vitamin deficiency.

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>).