1-Methylnicotinamide chloride Clinical Trials

Size	Price	Qty
25mg	USD 99
1g	USD 970

Clinical Trials

Multiple clinical trials have evaluated 1-methylnicotinamide chloride for lipid-regulating therapy and cardiovascular health, specifically examining hyperlipidemia, hypertriglyceridemia, and mixed hyperlipidemia. Led by industry sponsors such as Pharmena North America and Cortria Corporation, these completed early-phase evaluations included a randomized crossover pharmacokinetics study and a multi-center dose-escalation pilot study. Together, these investigations establish an initial human safety and efficacy profile for 1-methylnicotinamide in managing dyslipidemia.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02008084	COMPLETED	Hypertriglyceridemia; Mixed Hyperlipidemia	Cortria Corporation	2013-12	PHASE2
NCT00685737	Completed	Hyperlipidemia	Pharmena North America	2007-12	Phase 1

(data from https://clinicaltrials.gov, updated on 2016-01-27)

Check the 1-Methylnicotinamide chloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an active endogenous metabolite of nicotinamide, 1-methylnicotinamide chloride markedly stimulates prostacyclin generation and modulates vascular endothelial function to exert robust anti-thrombotic and anti-inflammatory activities. This enhancement of prostacyclin synthesis and endothelial protection supports vascular homeostasis, providing clinical relevance for regulating lipid profiles and treating hyperlipidemia and hypertriglyceridemia.

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>).