Company Overview - Gelteq Limited is a clinical and science-based company specializing in gel-based oral delivery solutions, headquartered in Melbourne, Australia [5] - The company is focused on developing and commercializing gel formulations for prescription drugs, nutraceuticals, pet care, and sports nutrition [5] Product Development - Gelteq plans to commence a preclinical bioequivalence study in September 2025 to evaluate a novel gel-based formulation of a widely used antihistamine for allergy treatment [1] - If preclinical results are successful, the company anticipates advancing to human clinical trials targeting FDA approval via the 505(b)(2) regulatory pathway [2] Market Opportunity - Allergic conditions affect over 50 million people annually in the United States, indicating a significant market for allergy treatments [3] - The global antihistamine market was valued at approximately USD 9 billion in 2023, growing at a 6% CAGR, projected to reach over USD 12 billion by 2028 [3][4] - Demand for antihistamines spans pediatric, adult, and animal health sectors, reflecting diverse applications for these therapies [3] Competitive Advantage - Gelteq's proprietary gel formulations aim to address limitations of traditional tablets and syrups, such as palatability for children, swallowing difficulties for the elderly, and precise dosing needs in veterinary medicine [4] - The innovative gel technology offers advantages in taste masking, ease of administration, and flexible dosing, particularly relevant in pediatric and veterinary care [5]