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Gelteq Announces Commencement of Preclinical Trial for Novel Gel-Based Antihistamine Formulation Targeting Allergy Market
Study to Support Potential FDA Approval via 505(b)(2) PathwayMELBOURNE, Australia, Sept. 05, 2025 (GLOBE NEWSWIRE) -- 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 E
About this update from Gelteq Limited
[{"type":"image","alt":"Gelteq Limited","displaySize":"","headline":null,"caption":"Gelteq Limited","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":45,"url":"https://media.zenfs.com/en/globenewswire.com/7b1e561b8eb101a1e67d96e6f6066b43"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/uXs2phR.sCaPuzjk7r6BAw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTYzO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/7b1e561b8eb101a1e67d96e6f6066b43","width":300,"height":45}},"lazy":false},{"type":"text","content":"Study to Support Potential FDA Approval via 505(b)(2) Pathway","length":61,"tagName":"p"},{"type":"text","content":"MELBOURNE, Australia, Sept. 05, 2025 (GLOBE NEWSWIRE) -- 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.","length":508,"tagName":"p"},{"type":"text","content":"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.","length":189,"tagName":"p"},{"type":"text","content":"“Our gel-based delivery platform is expected to transform traditional pharmaceutical products currently available on the market, especially where patient compliance and dosage control are critical,” said Nathan Givoni, CEO of Gelteq. “By applying our technology to a well-established antihistamine, we see a significant opportunity to capture value in the allergy market, where patient-friendly formats and flexible dosing remain unmet needs.”","length":443,"tagName":"p"},{"type":"text","content":"Allergic conditions affect over 50 million people annually in the United States alone (1). 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 (2). Demand spans paediatric, adult, and increasingly, animal health (3), reflecting the diverse applications for antihistamine therapies.","length":382,"tagName":"p"},{"type":"text","...