Pyridoxal phosphate Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of pyridoxal phosphate across metabolic, genetic, neurological, and cardiovascular conditions, including pseudoxanthoma elasticum, tardive dyskinesia, and myocardial ischemia. Spanning early phase 1 through phase 4 development to assess safety and efficacy, these studies encompass completed, active, recruiting, terminated, and withdrawn protocols. They are supported by a mixture of academic institutions and pharmaceutical sponsors, including Case Western Reserve University, Daiichi Sankyo, and Medicure.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04706013	RECRUITING	Pyridox(am)Ine 5'-Phosphate Oxidase Deficiency	Medicure	2024-02-16	PHASE3
NCT07469462	RECRUITING	Neural Inhibition; Anxiety; Depression	University of Reading	2026-05-01
NCT06234501	RECRUITING	Autism	University of Reading	2024-11-08
NCT04762316	COMPLETED	Uterine Fibroids Affecting Pregnancy	Trieu, Nguyen Thi, M.D.	2019-01-01	PHASE4
NCT05569252	Active not recruiting	Pseudoxanthoma Elasticum	Daiichi Sankyo\|PXE International	2022-10-20	Phase 2
NCT05025722	Completed	Pseudoxanthoma Elasticum	Daiichi Sankyo\|PXE International\|Thomas Jefferson University	2021-08-30	--
NCT03738943	COMPLETED	Receptor Blockade	Colorado State University	2019-02-07	EARLY_PHASE1
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
NCT01281878	COMPLETED	Primary Hyperoxaluria Type I	University of Cologne	2010-12	PHASE2
NCT00917293	TERMINATED	Tardive Dyskinesia	Medicure	2009-05	PHASE2
NCT01908452	WITHDRAWN	Tardive Dyskinesia	Beersheva Mental Health Center	2011-07	PHASE3
NCT00933998	COMPLETED	Diabetic Peripheral Neuropathy	Carolina Musculoskeletal Institute	2006-06
NCT00000588	COMPLETED	Anemia (Iron-Loading); Beta-Thalassemia; Hematologic Diseases; Hemoglobinopathies; Thalassemia; Iron Overload	Case Western Reserve University	1989-06-05	PHASE2
NCT00157716	COMPLETED	Coronary Artery Bypass Graft Surgery; Myocardial Ischemia; Reperfusion Injury; Myocardial Revascularization	Medicure	2004-04	PHASE2
NCT00402506	COMPLETED	Coronary Artery Bypass Graft Surgery; Myocardial Ischemia; Reperfusion Injury	Medicure	2006-11	PHASE3
NCT00157729	COMPLETED	Diabetes Mellitus Type 2; Hypertension; Metabolic Syndrome	Medicure	2004-08	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-10-16)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pyridoxal phosphate serves as an essential enzymatic coenzyme by covalently binding active-site lysine residues via Schiff base formation, thereby facilitating critical transamination, decarboxylation, and deamination reactions in amino acid metabolism and neurotransmitter biosynthesis. By restoring normal intracellular enzymatic function and mitigating metabolic pathway deficits, this cofactor addresses therapeutic mechanisms relevant to clinical trial conditions such as pyridoxine-dependent epilepsy, tardive dyskinesia, and myocardial ischemia.

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>).