Clinical Trials

A completed clinical trial evaluated methacholine chloride for assessing physiological parameters associated with endothelial dysfunction and related metabolic function. Conducted as an unphased study with a phase designation of Not Applicable, the trial was jointly sponsored by Indiana University and the National Heart, Lung, and Blood Institute (NHLBI). This research reflects the clinical application of the compound in evaluating vascular endothelial health.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00720590 Completed
Endothelial Dysfunction
Indiana University|National Heart Lung and Blood Institute (NHLBI)
 2003-11 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Methacholine chloride functions as a synthetic choline ester that selectively binds to and activates non-selective muscarinic acetylcholine receptors, triggering downstream G protein-coupled signal transduction pathways. This receptor activation promotes intracellular calcium mobilization to induce smooth muscle contraction and nitric oxide-mediated alteration of vascular tone, rendering it relevant for clinical investigations into endothelial dysfunction.

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>).

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Note: Technical data last updated: Sep 1, 2026.