Pyridoxal 5′-phosphate hydrate Clinical Trials

Size	Price	Qty
25mg	USD 107
1g	USD 490

Clinical Trials

Several clinical trials involving Pyridoxal 5′-phosphate encompass early-phase and pilot study designs evaluating upper limb amputation at the wrist, pseudoxanthoma elasticum, and healthy volunteer cohorts. With recruitment statuses ranging from active recruitment to full completion, these studies are supported by academic healthcare centers such as Azienda Ospedaliero Universitaria Pisana alongside industrial sponsors including Daiichi Sankyo and Alexion Pharmaceuticals.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06176482	Recruiting	Upper Limb Amputation at the Wrist	Azienda Ospedaliero Universitaria Pisana\|Scuola Superiore Sant''Anna di Pisa	2023-03-01	Not Applicable
NCT05569252	Active not recruiting	Pseudoxanthoma Elasticum	Daiichi Sankyo\|PXE International	2022-10-20	Phase 2
NCT05307978	Completed	Healthy	Alexion Pharmaceuticals Inc.	2022-04-12	Phase 1

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

Check the Pyridoxal 5′-phosphate hydrate 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 functions as an essential coenzyme that binds enzymatic targets, inhibits viral DNA polymerases, and disrupts NEIL2 interaction with damaged DNA, thereby suppressing aberrant enzymatic activity and modulating intracellular nucleic acid repair. These fundamental biochemical and cellular effects provide the biological foundation for evaluating Pyridoxal 5′-phosphate across clinical settings including pseudoxanthoma elasticum, upper limb amputation at the wrist, and healthy control populations.

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>).