Perhexiline maleate Clinical Trials

Size	Price	Qty
5mg	USD 259
25mg	USD 777

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3 have investigated the therapeutic potential of perhexiline maleate across cardiovascular conditions, including hypertrophic cardiomyopathy, chronic and diastolic heart failure, diabetic cardiomyopathy, and myocardial reperfusion injury. Sponsored by academic research institutions and industry partners, these studies evaluate metabolic support, cardiac energetics, and left ventricular remodeling. Registry records indicate recruitment statuses ranging from completed trials to unknown or withdrawn studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04426578	UNKNOWN	Hypertrophic Cardiomyopathy	Flinders University	2020-12-01	PHASE2
NCT02431221	WITHDRAWN	Hypertrophic Cardiomyopathy	Heart Metabolics Limited		PHASE3
NCT02862600	TERMINATED	Cardiomyopathy, Hypertrophic; Cardiomyopathy, Hypertrophic, Familial	Heart Metabolics Limited	2016-08-01	PHASE2
NCT00839228	COMPLETED	Diastolic Heart Failure	University of Aberdeen	2009-03	PHASE2
NCT00989508	UNKNOWN	Myocardial Reperfusion Injury; Cardiac Output, Low; Hypertrophy, Left Ventricular	University Hospital Birmingham	2009-10	PHASE2; PHASE3
NCT00841139	COMPLETED	Chronic Heart Failure	University Hospital Birmingham NHS Foundation Trust	2009-02	PHASE2
NCT00500552	COMPLETED	Hypertrophic Cardiomyopathy	University Hospital Birmingham	2006-12	PHASE2
NCT00845364	COMPLETED	Myocardial Reperfusion Injury; Cardiac Output, Low	University Hospital Birmingham	2007-02	PHASE2; PHASE3
NCT00628056	UNKNOWN	Diabetic Cardiomyopathy	University Hospital Birmingham	2006-10	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2021-03-11)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Perhexiline maleate functions as a potent inhibitor of carnitine palmitoyltransferase 1 (CPT1) and CPT2, effectively blocking long-chain fatty acid transport into the mitochondria and shifting cellular substrate utilization toward glucose oxidation. By promoting more oxygen-efficient energy production, this metabolic shift improves myocardial energetics and cellular viability, offering therapeutic relevance in clinical conditions such as hypertrophic cardiomyopathy, diastolic heart failure, and myocardial reperfusion injury.

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>).