N-Methylnicotinamide Clinical Trials

Size	Price	Qty
100mg	USD 147
1g	USD 247

Clinical Trials

Multiple clinical trials operating outside standard phase classifications evaluate N-Methylnicotinamide across diverse therapeutic settings, sponsored by academic and medical institutions including Stanford University, Vanderbilt University Medical Center, and Trinity College Dublin. A clinical trial actively recruiting participants assesses structured cardiac rehabilitation protocols in patients with single-ventricle congenital heart failure. Meanwhile, a clinical trial that is active but not recruiting investigates exercise and protein supplementation strategies to manage chronic disease, physical disability, and addiction among vulnerable populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06150950	Recruiting	Heart Failure Congenital\|Single-ventricle	Stanford University\|Vanderbilt University Medical Center\|Adult Congenital Heart Association\|Julie Fletcher Memorial Fund\|Pete Huttlinger Memorial Fund	2024-05-05	Not Applicable
NCT06264895	Active not recruiting	Social Exclusion\|Chronic Disease\|Physical Disability\|Addiction	University of Dublin Trinity College	2024-02-26	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

N-Methylnicotinamide functions as an active endogenous metabolite that modulates the asymmetric dimethylarginine-dimethylarginine dimethylaminohydrolase (ADMA-DDAH) axis to restore nitric oxide synthase signaling. By suppressing ADMA-induced oxidative stress and preserving microvascular endothelial integrity, this compound mitigates atherogenesis and vascular dysfunction, offering potential clinical utility in conditions characterized by chronic cardiovascular impairment and physical disability.

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>).