Comprehensive Report on GV-328 Lozenges for Pediatric Oral Aphthosis

1. Executive Summary

• Overview: GV-328 is the investigational designation for a lozenge formulation developed for the management of oral aphthosis (canker sores) in children. The active components of these lozenges are hyaluronic acid and zinc. Clinical evaluation, notably the NCT04677062 study, has explored its efficacy and safety in a pediatric population. Evidence suggests that this formulation is commercially available under the brand name "Oralchup," marketed by Laboratorios Viñas as a dietary or food supplement.[1]
• Key Findings: The primary clinical study (NCT04677062) involving GV-328 lozenges reported statistically significant reductions in pain intensity, lesion size, and associated functional limitations in children aged 3 to 13 years suffering from oral aphthae. Furthermore, the product demonstrated a favorable safety profile, with minimal adverse events, and was generally well-accepted by the pediatric participants, an important consideration for formulations intended for children.[1]
• Overall Assessment: Based on the available evidence, GV-328 lozenges (Oralchup) represent a potentially useful supportive treatment for symptomatic relief of acute oral aphthosis in children. Its classification as a dietary supplement means it is not subject to the same rigorous approval pathways as pharmaceutical drugs. The clinical evidence, while positive, stems from an open-label, non-controlled study, which should be considered when evaluating its efficacy relative to natural resolution or other interventions.
• Focus of the Report: It is imperative to note that this report focuses exclusively on the GV-328 lozenge formulation containing hyaluronic acid and zinc for pediatric oral aphthosis. The "GV-328" designation, or similar numerical identifiers, appears in scientific literature in association with entirely unrelated entities, including microRNAs and other investigational dru