Gelteq Announces Positive Preclinical Results Demonstrating Enhanced Bioavailability Using Its Proprietary Gel-Based Drug Delivery Platform
Rhea-AI Summary
Gelteq (ASX:GELS) announced positive preclinical pharmacokinetic results on Nov 24, 2025 showing its proprietary gel formulation produced a 38–45% increase in systemic exposure (AUC) versus a leading marketed antihistamine, plus markedly higher Cmax and a comparable Tmax. The company said the test compound was water-soluble, supporting broader application of the gel platform across other water-soluble drug classes and strengthening plans to pursue an FDA approval pathway for an antihistamine and to engage pharmaceutical partners.
Positive
- AUC improvement of 38–45% versus reference
- Cmax markedly higher, indicating stronger peak exposure
- Comparable Tmax preserves dosing timing and onset
- Supports pursuit of an FDA approval pathway for antihistamine
Negative
- Results are preclinical; no human clinical data reported
- Findings apply to water-soluble compounds only
- No binding commercial partnerships or regulatory timelines disclosed
News Market Reaction – GELS
In the Nov 24 session, GELS gained 20.39%, reflecting a significant positive market reaction. Argus tracked a peak move of +30.1% during that session. Argus tracked a trough of -7.8% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. Trading volume was exceptionally heavy at 114.1x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Findings Anticipated to Unlock Broad New Commercial Opportunities Across Water-Soluble Drug Classes
MELBOURNE, Australia, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Gelteq Limited (“Gelteq” or the “Company”), a clinical and science-based company specialising in gel-based oral delivery solutions, today announced positive preclinical results showing its proprietary gel formulation achieved substantially higher bioavailability than a leading on-market reference antihistamine product.
In a comparative pharmacokinetic study, Gelteq’s formulation demonstrated a 38–
“These results represent a major technical and commercial milestone for Gelteq,” said Nathan Givoni, CEO of Gelteq. “A 38–
Importantly, the findings extend beyond the specific antihistamine evaluated in the study. Because the test compound is water-soluble, the demonstrated bioavailability improvement provides a strong foundation for applying Gelteq’s platform across a range of other water-soluble drug classes, significantly broadening the Company’s commercial scope.
“These results support our strategy of partnering and developing gel-based formulations across a wide range of therapeutically relevant compounds,” Mr. Givoni added. “We believe this opens up opportunities well beyond the antihistamine market, and into much larger drug categories where improved absorption, ease of administration, and patient-friendly formats can create immediate value.”
The Company anticipates using these results to further pursue an FDA approval pathway for an antihistamine product and to increase engagement with potential pharmaceutical partners interested in next-generation drug delivery formats.
About Gelteq Ltd.
Headquartered in Melbourne, Australia, Gelteq (NASDAQ: GELS) is a clinical and science-based company dedicated to developing and commercialising gel-based oral delivery solutions for prescription drugs, nutraceuticals, pet care, sports nutrition, and other applications. Gelteq’s proprietary formulation technology aims to address challenges associated with conventional drug delivery, including taste masking, swallowing difficulties, and precision dosing.
For more information, visit www.gelteq.com.
Gelteq Contact:
Investor Relations
Matt Kreps, Darrow Associates IR
+1-214-597-8200
mkreps@darrowir.com
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.
