Bepotastine Besilate Clinical Trials

Size	Price	Qty
10mg	USD 70

Clinical Trials

Multiple completed clinical trials, sponsored by pharmaceutical entities including HK inno.N Corporation and Mitsubishi Tanabe Pharma Corporation, have evaluated Bepotastine Besilate across Phase 1 and Phase 3 settings. Early Phase 1 research assessed safety and crossover pharmacokinetic parameters in healthy volunteers, whereas a pivotal Phase 3 study confirmed its therapeutic efficacy and tolerability in pediatric patients with perennial allergic rhinitis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01925313	Completed	Healthy	HK inno.N Corporation	2012-12	Phase 1
NCT01425632	Completed	Perennial Allergic Rhinitis	Mitsubishi Tanabe Pharma Corporation	2011-08	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bepotastine Besilate selectively binds to and antagonizes the histamine 1 (H1) receptor, thereby blocking histamine-driven downstream signaling pathways and inhibiting capillary permeability, allergic inflammatory mediator release, and eosinophil infiltration. This targeted suppression of histamine-mediated cellular activity mitigates acute and chronic tissue inflammation, demonstrating primary therapeutic relevance in the clinical management of perennial allergic rhinitis.

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>).