2-Hydroxypyridine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial is currently actively recruiting participants to evaluate the effects of a 120-day supplementation intervention in individuals diagnosed with Sickle Cell Disease carrying the SS genotype. Operating as a pilot study without a formal phase designation, the trial is supported by a collaborative network of academic, health authority, and biotechnology sponsors. The ongoing investigation aims to characterize therapeutic outcomes and patient responses in sickle cell pathophysiology.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05789355	Recruiting	Sickle Cell Disease	LGD\|CEN Biotech\|Assistance Publique Hopitaux De Marseille\|Etablissement Français du Sang	2023-04-01	Not Applicable

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

Check the 2-Hydroxypyridine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

2-Hydroxypyridine acts as a tautomeric bifunctional catalyst that engages functional chemical residues to promote efficient amide coupling during peptide synthesis and metabolic substrate interactions. Through these catalytic interactions, the compound modulates downstream biochemical processes and cellular pathway stability, supporting therapeutic strategies aimed at mitigating pathological erythrocyte sickling and microvascular complications in Sickle Cell Disease.

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>).