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Gelteq To Begin Preclinical Study Of Gel-Based Antihistamine Formulation In September 2025, Aiming For FDA Approval Via 505(b)(2) Regulatory Pathway

Author: Benzinga Newsdesk | September 05, 2025 11:29am

Gelteq Limited ("Gelteq" or the "Company"), a clinical and science-based company specialising in gel-based oral delivery solutions, today announced plans to commence a preclinical bioequivalence study in September 2025 to evaluate its novel gel-based formulation of a widely used antihistamine for allergy treatment. The study will be conducted by Adgyl Lifesciences (a partner of Eurofins Advinus), a leader in preclinical contract research services.

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.

Posted In: GELS

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