Gelteq Limited disclosed that its proprietary gel formulation produced a 38–45% increase in systemic exposure (AUC) and higher peak concentrations (Cmax) compared with a leading on‑market antihistamine reference in a comparative pharmacokinetic study. The improvement was achieved while maintaining a comparable time to peak plasma concentration (Tmax), indicating that the gel platform enhances absorption without delaying drug action.
The study was conducted in an animal model and compared the gel‑based formulation to a water‑soluble antihistamine that is widely used in the market. While the reference drug’s name was not disclosed, the data demonstrate that the gel can significantly boost oral bioavailability for water‑soluble compounds, suggesting the technology could be applied to a broad range of similar drugs. The preclinical nature of the work means the results are not yet validated in humans, but they provide a strong proof of concept for future development.
CEO Nathan Givoni said the findings “validate Gelteq’s strategy of partnering and developing gel‑based formulations across therapeutically relevant compounds.” He added that the milestone supports the company’s plan to pursue FDA approval pathways and to engage pharmaceutical partners, positioning Gelteq to expand its product pipeline and accelerate revenue generation.
Gelteq is an early‑stage, unprofitable company with a market capitalization of roughly AUD 9.4 million and annual revenue of AUD 0.11 million. The company’s operating and net margins are negative, reflecting heavy investment in research and development. The preclinical breakthrough therefore represents a significant step toward commercial viability, but the company still faces the typical risks of translating animal data into human products, including regulatory hurdles and the need for further clinical testing.
The bioavailability boost could enable lower dosing or improved efficacy for future antihistamine products, potentially giving Gelteq a competitive edge in the oral delivery market. If the platform proves effective across other water‑soluble drugs, it could open new therapeutic areas and create additional partnership opportunities. Investors will likely view the milestone as a positive signal of technical progress, but will also monitor the company’s ability to convert preclinical success into marketable products and to manage the substantial costs associated with clinical development.
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