Gelteq Limited (NASDAQ: GELS) announced it has started its first clinical trial for an antiparasitic drug candidate using its proprietary delivery technology, according to a company statement.

The Melbourne-based biotechnology company said the trial aims to support a planned FDA regulatory submission for animal use, with a potential application targeted for 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."

The trial follows the FDA's acceptance of Gelteq's suitability petition, which the company described as a step toward regulatory approval for the antiparasitic drug candidate.

Gelteq expects the trial to generate data supporting the safety, efficacy, and formulation performance of its technology in animal health applications. The company cited industry research indicating the global animal health market is estimated to exceed $78 billion in 2026.

The company said it maintains sufficient capital following recent financing to execute its strategy of advancing pharmaceutical programs while continuing revenue generation through its commercial nutraceutical portfolio.

Gelteq specializes in a drug delivery platform using an ingestible gel form designed to improve how active ingredients are formulated and absorbed.