Gelteq plans preclinical study for a novel gel-based antihistamine, aiming for FDA approval to improve allergy treatment delivery.
Quiver AI Summary
Gelteq Limited, a company focused on gel-based oral delivery solutions, announced the initiation of a preclinical bioequivalence study for a novel gel-based antihistamine formulation aimed at treating allergies. This study, beginning in September 2025 and conducted by Adgyl Lifesciences, could pave the way for human clinical trials and potential FDA approval under the 505(b)(2) pathway, if successful. CEO Nathan Givoni emphasized the technology's potential to improve patient compliance and dosing flexibility, particularly in pediatric and veterinary contexts. The global antihistamine market is expected to grow significantly, highlighting the opportunity for Gelteq's innovative approach to address challenges associated with traditional antihistamine delivery methods.
Potential Positives
- Gelteq is set to conduct a preclinical bioequivalence study for a novel gel-based formulation of a widely used antihistamine, indicating progression toward FDA approval and potential market entry.
- The global antihistamine market is expected to grow significantly, presenting a substantial opportunity for Gelteq's innovative gel technology to capture market share in addressing unmet needs.
- The company's proprietary gel formulations aim to overcome challenges associated with traditional antihistamine delivery, enhancing patient compliance and dosage control, which are critical factors in the pharmaceutical industry.
Potential Negatives
- The announcement of a preclinical study indicates Gelteq is still in the early stages of product development, potentially delaying any market entry or revenue generation.
- There are inherent risks associated with the forward-looking statements about FDA approval and market capture, which may not materialize as anticipated.
- Gelteq’s reliance on partnerships, such as with Adgyl Lifesciences, may expose the company to operational and performance risks that are outside of its direct control.
FAQ
What is Gelteq Limited's recent announcement?
Gelteq announced plans to start a preclinical bioequivalence study on a novel gel-based antihistamine formulation in September 2025.
Who is conducting Gelteq's preclinical study?
The study will be conducted by Adgyl Lifesciences, a partner of Eurofins Advinus, specializing in preclinical contract research services.
What is the FDA 505(b)(2) regulatory pathway?
The FDA 505(b)(2) pathway allows for a streamlined approval process for new formulations of existing drugs based on existing studies.
How do Gelteq's gel formulations benefit patients?
Gelteq's gel formulations improve taste masking, ease of administration, and provide flexible dosing, addressing issues with traditional tablets and syrups.
What market opportunities does Gelteq see in antihistamines?
Gelteq aims to address the growing allergy treatment market, focusing on patient-friendly formats and flexible dosing solutions for various demographics.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
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.
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.
“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.”
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.
Gelteq’s proprietary gel formulations aim to address key limitations of traditional tablets and syrups, including palatability challenges for children, swallowing difficulties for elderly patients, and precise dosing needs in veterinary medicine (3).
“Our innovative gel technology offers potential advantages in taste masking, ease of administration, and flexible dosing,” added Mr. Givoni. “These attributes are particularly relevant in paediatrics and veterinary care where delivering effective allergy treatments can be challenging.”
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
[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 15, 2024. Gelteq undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.
References
- American College of Allergy, Asthma & Immunology. (2023). Allergy facts . American College of Allergy, Asthma & Immunology. https://acaai.org/allergies/
- Grand View Research. (2024, March). Antihistamine market size, share & trends analysis report . Grand View Research. https://www.grandviewresearch.com/industry-analysis/antihistamine-market
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MarketsandMarkets. (2023, November).
Veterinary dermatology drugs market by product, animal type, route of administration, end user – Global forecast to 2028
. MarketsandMarkets.
https://www.marketsandmarkets.com/Market-Reports/veterinary-dermatology-drugs-market-177021512.html
