Cevimeline HCl hemihydrate Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

In a Phase 4 clinical trial sponsored by academic and professional research institutions, including Duke University and the American Academy of Otolaryngology-Head and Neck Surgery Foundation, Cevimeline HCl hemihydrate was evaluated for the treatment of xerostomia. With recruitment fully completed, this multicenter study focused on assessing the agent's efficacy in managing oral dryness symptoms and evaluating treatment outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00466388	Completed	Xerostomia	American Academy of Otolaryngology-Head and Neck Surgery Foundation\|Duke University	2007-05	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cevimeline HCl hemihydrate selectively binds to and activates muscarinic acetylcholine receptors M1 and M3, stimulating downstream G-protein-coupled signaling cascades and intracellular calcium mobilization in exocrine tissue. This agonist activity promotes exocrine secretion and increases salivary flow, addressing the functional impairments associated with xerostomia in clinical settings.

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>).