Clinical Trials

A clinical trial sponsored by Semmelweis University evaluates the physiological action of acetylcholine chloride, specifically investigating endothelium-dependent vasodilatory responses in human gingival tissue relative to serum estrogen levels. This academic study focuses on oral soft tissue conditions without a specified clinical phase, and its recruitment status is listed as unknown. Overall, research on this compound remains limited to exploratory investigation rather than an extensive multi-center drug development program.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06454084 UNKNOWN
Vasodilation; Oral Soft Tissue Conditions
Semmelweis University
 2023-09-01

(data from https://clinicaltrials.gov, updated on 2024-06-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Acetylcholine chloride binds to muscarinic acetylcholine receptors on endothelial cells, stimulating downstream G-protein signaling that promotes nitric oxide synthesis and release into vascular smooth muscle. This cellular cascade induces smooth muscle relaxation, leading to peripheral vasodilation relevant to the study of microvascular perfusion in oral soft tissue conditions.

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.