MELBOURNE, Australia, May 20, 2026 (GLOBE NEWSWIRE) -- Gelteq Limited (“Gelteq”) today announced the commencement of its first clinical trial for an antiparasitic drug candidate powered by Gelteq® technology, marking a significant milestone as the Company expands into the veterinary pharmaceutical sector.
The clinical trial seeks to support Gelteq’s planned FDA regulatory pathway for animal use, with the Company targeting a potential application later in 2026.
“This clinical trial represents a significant milestone for Gelteq as we expand into the veterinary pharmaceutical market,” said Nathan Givoni, CEO of Gelteq. “Building on our prior regulatory progress with the FDA, we are now advancing a key drug candidate powered by Gelteq® technology into the clinical stage as we work toward a potential regulatory submission in 2026. This step seeks to reinforce the versatility of Gelteq® technology and its potential across both human and animal health applications.”
Advancing Toward FDA Applications
Commencement of the clinical trial builds on Gelteq’s prior announcement regarding the FDA’s acceptance of its suitability petition, representing a key step in progressing the antiparasitic drug candidate powered by Gelteq® technology toward regulatory approval.
The trial is expected to generate critical data to support the safety, efficacy, and formulation performance of Gelteq® technology in an animal health setting.
Positioned for Continued Clinical and Commercial Progress
With the clinical trial now underway, Gelteq intends to generate data that will support both regulatory progression and future commercial opportunities within the veterinary sector. The global animal health market is estimated to exceed USD $78 billion in 2026, with antiparasitic treatments representing a significant segment driven by increasing pet ownership and ongoing demand for parasite prevention and control1.
As Gelteq advances this program toward potential regulatory approval, the Company believes it is strategically positioned to participate in a large and growing market segment, where improved delivery formats may offer meaningful advantages in compliance and dosing.
With Gelteq’s recent financing, the Company believes it is well positioned with sufficient capital to execute on its dual-track strategy of advancing pharmaceutical programs for long-term value while continuing to drive near-term revenue through its commercial nutraceutical portfolio.
About Gelteq Ltd.
Headquartered in Melbourne, Australia, Gelteq (NASDAQ: GELS) is a biotechnology company that has developed a novel drug delivery platform in an ingestible gel form. Gelteq® technology, a proprietary delivery technology, is designed to improve how active ingredients are formulated, stabilised and absorbed by the body. Gelteq specializes in research and development, product creation and manufacturing for partners across pharmaceutical, consumer health and animal health markets. Gelteq® technology aims to address challenges associated with conventional drug and nutrient delivery by enhancing bioavailability, improving patient compliance, and enabling precise dosing. For more information, visit www.gelteq.com
Gelteq Contact:
Investor Relations
Matt Kreps, Darrow Associates IR
+1-214-597-8200
[email protected]
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, contained herein are forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied in such statements. For a discussion of these risks and uncertainties, refer to Gelteq’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F filed on November 17, 2025. Gelteq undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.
1 Fortune Business Insights. (2025). Animal health market size, share & industry analysis. Report ID: FBI102371