Gelteq Announces Commencement of Preclinical Trial for Novel Gel-Based Antihistamine Formulation Targeting Allergy Market
Gelteq (GELS) announced the initiation of a preclinical bioequivalence study for its novel gel-based antihistamine formulation in September 2025. The study, conducted by Adgyl Lifesciences, aims to evaluate the company's proprietary gel technology for allergy treatment targeting FDA approval through the 505(b)(2) pathway.
The company is targeting the global antihistamine market, valued at $9 billion in 2023 with a projected growth to $12 billion by 2028 at a 6% CAGR. The technology aims to address limitations in traditional delivery methods, focusing on improved palatability, administration ease, and precise dosing for pediatric, elderly, and veterinary applications.
Gelteq (GELS) ha avviato a settembre 2025 uno studio preclinico di bioequivalenza per la sua nuova formulazione antistaminica a base di gel. Lo studio, condotto da Adgyl Lifesciences, valuter脿 la tecnologia proprietaria a gel dell'azienda per il trattamento delle allergie, con l'obiettivo di ottenere l'approvazione FDA tramite la via 505(b)(2).
L'azienda si rivolge al mercato globale degli antistaminici, stimato 9 miliardi di dollari nel 2023 e previsto in crescita fino a 12 miliardi entro il 2028 a un tasso annuo composto del 6%. La tecnologia punta a superare i limiti dei metodi di somministrazione tradizionali, migliorando palatabilit脿, facilit脿 d'uso e dosaggio preciso per applicazioni pediatriche, geriatrich e veterinarie.
Gelteq (GELS) anunci贸 en septiembre de 2025 el inicio de un estudio precl铆nico de bioequivalencia para su nueva formulaci贸n antihistam铆nica en gel. El estudio, realizado por Adgyl Lifesciences, evaluar谩 la tecnolog铆a de gel propietaria de la compa帽铆a para el tratamiento de alergias, con la meta de obtener la aprobaci贸n de la FDA a trav茅s de la v铆a 505(b)(2).
La empresa apunta al mercado mundial de antihistam铆nicos, valorado en 9.000 millones de d贸lares en 2023 y proyectado a 12.000 millones para 2028 con una CAGR del 6%. La tecnolog铆a busca resolver limitaciones de los m茅todos tradicionales de administraci贸n, enfoc谩ndose en mejorar la palatabilidad, la facilidad de uso y la dosificaci贸n precisa para aplicaciones pedi谩tricas, geri谩tricas y veterinarias.
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Gelteq (GELS) a annonc茅 en septembre 2025 le lancement d'une 茅tude pr茅clinique de bio茅quivalence pour sa nouvelle formulation antihistaminique en gel. L'茅tude, men茅e par Adgyl Lifesciences, vise 脿 茅valuer la technologie propri茅taire de gel de la soci茅t茅 pour le traitement des allergies, en vue d'obtenir l'approbation de la FDA via la voie 505(b)(2).
La soci茅t茅 cible le march茅 mondial des antihistaminiques, 茅valu茅 脿 9 milliards de dollars en 2023 et pr茅vu d'atteindre 12 milliards d'ici 2028 avec un TCAC de 6%. La technologie entend pallier les limites des modes d'administration traditionnels en am茅liorant la palatabilit茅, la facilit茅 d'administration et le dosage pr茅cis pour les usages p茅diatriques, g茅riatriques et v茅t茅rinaires.
Gelteq (GELS) gab im September 2025 den Beginn einer pr盲klinischen Bio盲quivalenzstudie f眉r seine neue gelbasierte Antihistamin-Formulierung bekannt. Die Studie wird von Adgyl Lifesciences durchgef眉hrt und soll die firmeneigene Geltechnologie zur Allergiebehandlung bewerten, mit dem Ziel einer FDA-Zulassung 眉ber den 505(b)(2)-Weg.
Das Unternehmen zielt auf den globalen Antihistaminmarkt ab, der 2023 mit 9 Milliarden US-Dollar bewertet wurde und bis 2028 voraussichtlich auf 12 Milliarden bei einer j盲hrlichen Wachstumsrate (CAGR) von 6% anw盲chst. Die Technologie soll Einschr盲nkungen herk枚mmlicher Verabreichungsformen 眉berwinden und insbesondere Geschmack, Anwendbarkeit und pr盲zise Dosierung f眉r p盲diatrische, geriatrische und veterin盲rmedizinische Anwendungen verbessern.
- Targeting large market opportunity with over 50 million affected patients annually in US alone
- Addressing unmet needs in drug delivery for multiple patient populations
- Potential to leverage faster 505(b)(2) FDA approval pathway
- Global antihistamine market growing at 6% CAGR
- Still in early preclinical stage with no guaranteed success
- Will require significant time and resources to complete clinical trials
- Faces competition from established antihistamine products
Insights
Gelteq begins preclinical testing of gel antihistamine formulation, targeting $9B market via 505(b)(2) FDA pathway.
Gelteq has initiated a preclinical bioequivalence study for its gel-based antihistamine formulation, marking an early-stage development milestone. The company has partnered with Adgyl Lifesciences to conduct the study, which could potentially lead to human clinical trials if successful.
The company is pursuing FDA approval through the 505(b)(2) regulatory pathway, which allows for a more streamlined approval process for reformulations of existing approved drugs. This approach typically requires fewer clinical studies and shorter development timelines than traditional approval routes.
Gelteq's strategy targets the global antihistamine market valued at $9 billion with a 6% CAGR, projected to reach $12 billion by 2028. The company aims to address specific limitations in current delivery methods, particularly focusing on pediatric patients who struggle with tablets, elderly patients with swallowing difficulties, and veterinary applications requiring precise dosing.
While this announcement represents a positive step in Gelteq's product development pipeline, investors should note that preclinical testing is an early stage in drug development. The company must still demonstrate bioequivalence in this preclinical model before advancing to human trials. Even with the streamlined 505(b)(2) pathway, several years of development work likely remain before potential commercialization.
The company's gel technology platform could potentially create differentiated products in established markets, but success will depend on demonstrating meaningful improvements in patient compliance, dosing accuracy, or other clinically relevant advantages compared to existing formulations.
Study to Support Potential FDA Approval via 505(b)(2) Pathway
MELBOURNE, Australia, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Gelteq Limited (鈥淕elteq鈥� or the 鈥淐ompany鈥�), 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.
鈥淥ur 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,鈥� said Nathan Givoni, CEO of Gelteq. 鈥淏y 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.鈥�
Allergic conditions affect over 50 million people annually in the United States alone (1). The global antihistamine market was valued at approximately USD
Gelteq鈥檚 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).
鈥淥ur innovative gel technology offers potential advantages in taste masking, ease of administration, and flexible dosing,鈥� added Mr. Givoni. 鈥淭hese attributes are particularly relevant in paediatrics and veterinary care where delivering effective allergy treatments can be challenging.鈥�
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鈥檚 proprietary formulation technology aims to address challenges associated with conventional drug delivery, including taste masking, swallowing difficulties, and precision dosing. For more information, visit .
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 鈥渇orward-looking statements鈥� 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鈥檚 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.
- Grand View Research. (2024, March). Antihistamine market size, share & trends analysis report. Grand View Research.
- MarketsandMarkets. (2023, November). Veterinary dermatology drugs market by product, animal type, route of administration, end user 鈥� Global forecast to 2028. MarketsandMarkets.
FAQ
When will Gelteq (GELS) begin its preclinical trials for the gel-based antihistamine?
What is the market size for antihistamines that Gelteq (GELS) is targeting?
What regulatory pathway is Gelteq (GELS) pursuing for its gel-based antihistamine?
What advantages does Gelteq's (GELS) gel-based antihistamine formulation offer?
How many people are affected by allergic conditions in the United States?
