Levocetirizine Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 290

Clinical Trials

Multiple clinical trials are evaluating Levocetirizine across diverse indications, including allergic rhinitis and neoplasms. A completed Phase 1 bioequivalence study sponsored by GlaxoSmithKline and Zensei Pharmaceutical Co. Ltd. addressed rhinitis treatment, whereas an active Phase 1/2 study sponsored by Advanced Accelerator Applications is currently recruiting patients to evaluate safety, dosimetry, and anti-tumor activity in neoplasms. Together, these industry-sponsored trials demonstrate the ongoing evaluation of Levocetirizine in both traditional allergic and emerging oncological indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03872778	Recruiting	Neoplasms	Advanced Accelerator Applications	2019-07-24	Phase 1\|Phase 2
NCT03555890	Completed	Rhinitis	GlaxoSmithKline\|Zensei Pharmaceutical Co. Ltd.	2018-05-18	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Levocetirizine selectively binds as a competitive antagonist to peripheral histamine H1 receptors, suppressing histamine-mediated downstream signaling pathways and reducing vascular permeability and inflammatory mediator release. This cellular inhibition attenuates acute allergic cascades, providing clinical efficacy in managing rhinitis symptoms while also being explored for therapeutic potential in neoplastic 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>).