Nicotinuric acid Clinical Trials

Size	Price	Qty
25mg	USD 99

Clinical Trials

Multiple clinical trials have evaluated nicotinic acid metabolic pathways and nicotinuric acid biotransformation in conditions such as Parkinson's disease and heterozygous familial hypercholesterolemia. These include a completed study of unassigned phase sponsored by the VA Office of Research and Development on GPR109A receptor signaling, as well as a terminated Phase I trial sponsored by Merck Sharp & Dohme LLC assessing extended-release niacin in adolescent patients. Together, these studies demonstrate clinical interest in niacin receptor signaling across neurodegenerative and metabolic disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03462680	Completed	Parkinson''s Disease	VA Office of Research and Development	2016-09-28	Not Applicable
NCT01583647	Terminated	Hypercholesterolemia Familial\|Heterozygous Familial Hypercholesterolemia	Merck Sharp & Dohme LLC	2012-06	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nicotinuric acid is formed through the enzymatic conjugation of nicotinic acid with glycine in hepatic mitochondria, acting as the primary detoxification metabolite and a quantitative biomarker for niacin clearance. Quantitative assessment of this biotransformation metabolite allows evaluation of hepatic metabolic flux and receptor signaling dynamics, providing relevant diagnostic insight for therapeutic studies in familial hypercholesterolemia and Parkinson's 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>).