Xylometazoline Clinical Trials

Size	Price	Qty
5mg	USD 107
25mg	USD 327

Clinical Trials

Multiple clinical trials have investigated the therapeutic application of xylometazoline for managing common cold symptoms, including completed Phase 3 and Phase 4 evaluations sponsored by Novartis and HALEON. These industry-sponsored studies assessed key clinical outcomes such as decongestant onset, duration of relief, overall efficacy, and real-world quality of life parameters. Together, these trials provide critical data regarding the clinical performance and patient-reported benefits of xylometazoline formulations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05556148	Completed	Common Cold	HALEON	2022-11-07	Phase 4
NCT00452270	Completed	Common Cold	Novartis	2007-03	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Xylometazoline acts as an agonist of alpha-adrenergic receptors, inducing constriction of nasal vascular smooth muscle cells and reducing mucosal blood flow. This vascular constriction decreases tissue edema and airway resistance, thereby relieving nasal congestion associated with common cold infections.

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>).