Acipimox Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Acipimox is documented in several clinical trials evaluating the metabolic consequences of lipolysis inhibition—such as skeletal muscle glucose utilization, glycogen dynamics, insulin sensitivity, and vascular function—primarily in pre-diabetes and type 2 diabetes mellitus. Encompassing Phase 1/Phase 2 and unassigned phase protocols, these studies range from completed trials to those currently actively recruiting participants. The research landscape involves academic, governmental, and industry sponsors, including Maastricht University Medical Center, Brigham and Women's Hospital, the University of Colorado Denver, the US Department of Veterans Affairs, and Pfizer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06317142	Recruiting	Pre Diabetes	Maastricht University Medical Center	2024-02-20	--
NCT01580813	Completed	Type 2 Diabetes	University of Colorado Denver\|US Department of Veterans Affairs\|Pfizer	2011-06	Not Applicable
NCT00153179	Completed	Type 2 Diabetes Mellitus	Brigham and Women''s Hospital	2005-09	Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Acipimox functions as a niacin derivative that inhibits lipolysis and hepatic triglyceride production, leading to decreased secretion of very-low-density lipoproteins and circulating free fatty acids. By lowering systemic free fatty acid levels, Acipimox alleviates lipid-induced insulin resistance and improves tissue glucose dynamics, which underlines its therapeutic relevance in managing pre-diabetes and type 2 diabetes mellitus.

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>).