GeRX-561

GeRX-561 is an oral gel-based formulation of a widely used, water-soluble antihistamine developed by Gelteq for the treatment of allergies. Utilizing Gelteq's proprietary ingestible gel delivery platform, GeRX-561 is designed to enhance the bioavailability and absorption of the active pharmaceutical ingredient while addressing common drug delivery challenges such as swallowing difficulties (dysphagia), palatability, and precise dosing. In preclinical bioequivalence studies, the formulation demonstrated a 38–45% increase in systemic exposure (AUC) and significantly higher peak concentrations (Cmax) compared to a leading on-market reference antihistamine product. Gelteq is advancing GeRX-561 toward human clinical trials via the FDA's 505(b)(2) regulatory pathway.