Pyridoxal hydrochloride Clinical Trials

Size	Price	Qty
100mg	USD 147

Clinical Trials

Several clinical trials are evaluating Phase 3 candidate therapies along with Phase Not Applicable observational and device-based interventions. These studies target conditions including Prader-Willi syndrome with hyperphagia, chronic musculoskeletal pain, coronary artery disease with chronic total occlusion, and thumb base osteoarthritis. Sponsored by commercial entities and academic research institutions—including Harmony Biosciences, ACADIA Pharmaceuticals, and Karolinska Institutet—these trials are currently recruiting or preparing to recruit participants.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06366464	Recruiting	Prader-Willi Syndrome	Harmony Biosciences LLC	2024-04-30	Phase 3
NCT06297447	Recruiting	Musculoskeletal Pain\|Chronic Pain	Bettina Eiger\|University of Southern Denmark\|Aalborg University\|Central Denmark Region\|Vrije Universiteit Brussel	2024-03-11	Not Applicable
NCT06275386	Not yet recruiting	Coronary Artery Disease\|Total Occlusion of Coronary Artery	National Institute of Cardiology Warsaw Poland	2024-03-01	Not Applicable
NCT06193499	Recruiting	Osteoarthritis Thumb	Karolinska Institutet	2024-01-17	Not Applicable
NCT06173531	Recruiting	Hyperphagia in Prader-Willi Syndrome	ACADIA Pharmaceuticals Inc.	2023-11-27	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pyridoxal hydrochloride functions as an active endogenous vitamin B6 metabolite that undergoes cellular phosphorylation to generate pyridoxal 5'-phosphate, an essential coenzyme required for enzymatic transamination, decarboxylation, and neurotransmitter biosynthesis. By sustaining crucial enzymatic pathways involved in metabolic and neuromuscular signaling, this compound modulates fundamental cellular processes relevant to clinical conditions evaluated in trials, such as chronic musculoskeletal pain, vascular occlusion in coronary artery disease, and neurodevelopmental hyperphagia in Prader-Willi syndrome.

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>).