Gelteq Limited announced plans to commence a preclinical bioequivalence study in September 2025 to evaluate its novel gel-based formulation of a widely used antihistamine. The study will be conducted by Adgyl Lifesciences, a partner of Eurofins Advinus.
If preclinical results are successful, Gelteq anticipates advancing to human clinical trials, targeting U.S. Food and Drug Administration (FDA) approval via the 505(b)(2) regulatory pathway. This pathway is designed for products that are similar to an already approved drug but with changes that require new clinical data.
The global antihistamine market was valued at approximately USD $9 billion in 2023 and is projected to reach over USD $12 billion by 2028. Gelteq's proprietary gel formulations aim to address key limitations of traditional tablets and syrups, such as palatability and swallowing difficulties, offering potential advantages in patient compliance and flexible dosing.
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