Gelteq Announces Commencement of Preclinical Trial Targeting Oil Soluble Drug Market with Novel Delivery Platform
Gelteq (ASX:GELS) announced the commencement of a preclinical animal trial on October 23, 2025 to evaluate its proprietary gel-based oral formulation technology for oily and poorly soluble drugs. The study is being conducted with Monash University Institute of Pharmaceutical Science. The company highlights that >40% of marketed drugs and up to 90% of discovery candidates have low solubility, and notes the global industry spends more than USD $4 billion annually on delivery technologies. Gelteq said successful results could enable pipeline salvage, lifecycle extension, and reduced API dose size for clients.
Gelteq (ASX:GELS) ha annunciato l'inizio di una prova preclinica su animali il 23 ottobre 2025 per valutare la sua tecnologia proprietaria di formulazione orale a base gel per farmaci oleosi e poco solubili. Lo studio è condotto con l'Istituto di Scienze Farmaceutiche dell'Università Monash. L'azienda sottolinea che oltre il 40% dei farmaci commercializzati e fino al 90% dei candidati in scoperta hanno una bassa solubilità, e nota che l'industria globale spende più di USD $4 miliardi all'anno in tecnologie di somministrazione. Gelteq ha dichiarato che risultati positivi potrebbero permettere il recupero della pipeline, l'estensione del ciclo di vita e una riduzione della dose di API per i clienti.
Gelteq (ASX:GELS) anunció el inicio de un ensayo preclínico en animales el 23 de octubre de 2025 para evaluar su tecnología propietaria de formulación oral basada en gel para fármacos oleosos y poco solubles. El estudio se está llevando a cabo con el Instituto de Ciencias Farmacéuticas de la Universidad Monash. La compañía destaca que >40% de los fêRMacos comercializados y hasta el 90% de los candidatos en descubrimiento tienen baja solubilidad, y señala que la industria global gasta más de USD $4 mil millones al año en tecnologías de entrega. Gelteq dijo que resultados exitosos podrían permitir la recuperación de la cartera, la extensión del ciclo de vida y la reducción de la dosis de API para los clientes.
Gelteq (ASX:GELS)는 2025년 10월 23일 전임상 동물 시험의 시작을 발표하여 기름진 및 용해도가 낮은 약물용 젤 기반 경구 제형 기술을 평가합니다. 연구는 모나시 대학 약학과와 함께 진행됩니다. 회사는 시판 약물의 >40%가 낮은 용해성을 가지며 발견 후보의 최대 90%도 용해도가 낮다고 강조하고, 글로벌 산업이 전달 기술에 연간 미화 40억 달러 이상을 지출한다고 지적합니다. Gelteq는 성공적인 결과가 파이프라인 회생, 수명 주기 연장 및 고객을 위한 API 용량 감소로 이어질 수 있다고 말했습니다.
Gelteq (ASX:GELS) a annoncé le démarrage d’un essai préclinique sur animal le 23 octobre 2025 afin d’évaluer sa technologie proprio de formulation orale à base de gel pour les médicaments huileux et peu solubles. L’étude est menée avec l’Institut des sciences pharmaceutiques de l’Université Monash. L’entreprise souligne que >40% des médicaments commercialisés et jusqu’à 90% des candidats à la découverte présentent une faible solubilité, et note que l’industrie mondiale dépense plus de USD 4 milliards de dollars par an en technologies de délivrance. Gelteq a ajouté que des résultats positifs pourraient permettre la récupération du pipeline, l’allongement du cycle de vie et une réduction de la dose d’API pour les clients.
Gelteq (ASX:GELS) kündigte am 23. Oktober 2025 den Beginn eines präklinischen Tierversuchs an, um ihre proprietäre gelbasierte orale Formulierungstechnologie für fetthaltige und schlecht lösliche Arzneimittel zu bewerten. Die Studie wird in Zusammenarbeit mit dem Monash University Institute of Pharmaceutical Science durchgeführht. Das Unternehmen hebt hervor, dass >40% der vermarkteten Medikamente und bis zu 90% der Entdeckungskandidaten eine geringe Löslichkeit aufweisen, und bemäklt, dass die globale Industrie mehr als USD 4 Milliarden pro Jahr für Liefertechnologien ausgibt. Gelteq sagte, erfolgreiche Ergebnisse könnten die Pipeline-Wiederherstellung, die Lebenszyklusverlängerung und eine Reduzierung der API-Dosisgröße für Kunden ermöglichen.
Gelteq (ASX:GELS) أعلنت عن بدء اختبار ما قبل السريرية على الحيوانات في 23 أكتوبر 2025 لتقييم تقنيتها الحصرية لصياغة فموية معتمدة على هلام للأدوية الدهنية وقليلة الذوبان. تُجرى الدراسة بالتعاون مع معهد علوم الصيدلة في جامعة موناش. وتبرز الشركة أن >40% من الأدوية المسوقة وبحدود 90% من مرشحي الاكتشاف لديهم قابلية ذوبان منخفضة، وتشير إلى أن الصناعة العالمية تنفق أكثر من 4 مليارات دولار أمريكي سنوياً على تقنيات التوصيل. قالت Gelteq إن النتائج الناجحة قد تمكّن من إنقاذ خط الإنتاج، وتمديد دورة الحياة، وخفض جرعة API للعملاء.
Gelteq (ASX:GELS) 于2025年10月23日宣布开始一项临床前动物试验，以评估其专有的基于凝胶的口服制剂技术，用于油性和难溶药物。该研究与莫纳什大学药物科学研究所共同开展。公司强调，>40%的已上市药物和高达90%的发现候选药物具有低溶解度，并指出全球行业在递送技术上的支出每年超过USD $40亿。Gelteq表示，若取得成功的结果，可能实现管线挽救、生命周期延长，并为客户降低API剂量。
- Preclinical animal trial commenced on Oct 23, 2025
- Collaborative study with Monash University
- Addresses solubility issues affecting >40% of marketed drugs and up to 90% of discovery candidates
- Trial is at a preclinical stage with no human efficacy or safety data yet
- Commercial outcomes are conditional on successful trial results and further development
Insights
Preclinical start shows technical validation intent but offers no efficacy or human data yet.
Gelteq has started a preclinical animal study with Monash University Institute of Pharmaceutical Science to test a proprietary gel formulation for oily and poorly soluble drugs, addressing a stated problem where >
Biologically, success in animals would only show proof‑of‑concept for absorption and tolerability in that model; it does not confirm human pharmacokinetics or safety. Key risks include species differences in GI physiology and the absence of human bioavailability data at this stage. Watch for preclinical endpoints (bioavailability, release profile, GI histology) and timing of any translational studies within the next 12–36 months.
Early-stage program could enable partnership opportunities but commercial outcomes remain speculative.
Gelteq frames the program as a route to "pipeline salvage," "lifecycle extension," and "improved adherence," targeting technologies where the market reportedly spends >
Immediate commercial dependencies include reproducible data across different APIs, avoidance of emulsifier safety concerns, and credible IP/partnering terms. Concrete milestones to monitor are preclinical readouts (bioavailability and safety) and any announced collaborations or licensing discussions; expect initial commercial signals to appear 12–24 months after convincing preclinical data.
Collaboration with Monash University to Address a Large Pharmaceutical Opportunity
MELBOURNE, Australia, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Gelteq Limited (“Gelteq” or the “Company”), a clinical and science-based company specialising in gel-based oral delivery solutions, today announced it has started a preclinical animal trial evaluating its proprietary formulation technology for oily and poorly soluble drugs. Gelteq will conduct the study with Monash University Institute of Pharmaceutical Science, a recognised leader in pharmaceutical development and contract research.
“Effective oral delivery of oily and poorly soluble drugs represents one of the biggest challenges in drug development and commercialisation,” said Nathan Givoni, CEO of Gelteq. “More than
Pharmaceutical companies invest more than USD
Should Gelteq be able to demonstrate through the trial its ability to work successfully with oily or poorly soluble drugs, Gelteq would seek to assist potential clients with a portfolio of oily and poorly soluble drugs via the following commercial options:
- Pipeline salvage – reviving promising drug molecules previously abandoned due to solubility and bioavailability issues.
- Lifecycle extension – reformulating existing drugs to provide new patent protection and exclusivity.
- Improved adherence – the potential to reduce API dose size and food-effect dependence, which has the potential for fewer side effects and more consistent patient outcomes.
“This preclinical trial represents an important step to demonstrate Gelteq’s ability to transform a major and unmet need across the pharmaceutical industry,” added Mr. Givoni.
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 (“SEC”), including its Annual Report on Form 20-F filed on November 15, 2024 and its Registration Statement on Form F-1 initially filed with the SEC on July 1, 2025. Gelteq undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.
References
- 360iResearch. (2024). Solubility enhancement excipients market: Global forecast 2025–2032 (Report ID: 5675273). Research and Markets.
- Allied Market Research. (2025). Targeted liposomes drug delivery market: Global opportunity analysis and industry forecast, 2023–2032 (Report ID: A12661).
- Grand View Research. (2025). Lipid nanoparticle market, 2025–2030 (Report ID: GVR-4-68040-547-5).
- Subramaniam, S., Elz, A., Wignall, A., Kamath, S., Ariaee, A., Hunter, A., et al. (2023). Self-emulsifying drug delivery systems (SEDDS) disrupt the gut microbiota and trigger an intestinal inflammatory response in rats. International Journal of Pharmaceutics, 648, 123614.
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