Gelteq Announces Commencement of Preclinical Trial Targeting Oil Soluble Drug Market with Novel Delivery Platform
MWN-AI** Summary
Gelteq Limited, an innovative company based in Melbourne, Australia, has announced the initiation of a preclinical trial to explore its proprietary formulation technology for oily and poorly soluble drugs. This trial, conducted in collaboration with the renowned Monash University Institute of Pharmaceutical Science, aims to tackle one of the pharmaceutical industry's significant challenges: the effective oral delivery of these difficult-to-formulate drugs.
CEO Nathan Givoni emphasized that over 40% of marketed drugs—and up to 90% of new candidates—suffer from low solubility and variable bioavailability, which can result in higher doses, increased side effects, and unpredictable patient outcomes. Gelteq’s delivery platform seeks to unlock the potential of these drugs, potentially reviving many that have been shelved due to solubility issues and offering new commercial avenues for pharmaceutical partners.
The market for enhancing the delivery of oily and poorly soluble drugs is substantial, with companies investing more than USD $4 billion annually in developing advanced technologies. Gelteq's approach is particularly timely, as concerns rise regarding the impact of traditional emulsifiers on gut health, prompting a need for safer formulations.
Should it prove successful, Gelteq's technology could lead to several commercial options, including the revival of abandoned drug candidates (pipeline salvage), reformulation of existing drugs for prolonged patent protection (lifecycle extension), and improvements in patient adherence by reducing dosage sizes and side effects.
This preclinical trial marks a crucial step for Gelteq in demonstrating its capability to address unmet needs in the pharmaceutical sector, potentially leading to significant innovations in drug delivery solutions across multiple markets.
MWN-AI** Analysis
In light of Gelteq Limited's recent announcement regarding the commencement of preclinical trials for its novel gel-based oral delivery platform, it is crucial for investors to consider the implications for the broader pharmaceutical market, particularly within the realm of oily and poorly soluble drugs.
Gelteq’s focus on solving the long-standing challenges associated with the delivery of more than 40% of marketed drugs is compelling. The company's proprietary formulation technology could potentially enhance drug solubility and bioavailability, addressing a consistent issue that has hindered pharmaceutical development. Given that pharmaceutical companies collectively invest over $4 billion annually to improve drug delivery methods, Gelteq's advances could place it in a prime position to capture a sizable share of this market.
Potential investors should be mindful of the competitive landscape. Gelteq is not the only player attempting to innovate in drug delivery; however, the growing concern regarding gut health and the adverse effects of traditional lipid-based formulations could provide Gelteq with a strategic edge, especially if its trials yield positive results. The emphasis on lifecycle extension and pipeline salvage also presents attractive avenues for collaboration with pharmaceutical companies seeking to revitalize stalled projects or extend the commercial viability of existing drugs.
Nevertheless, investors should conduct a thorough risk assessment. The success of Gelteq’s technology hinges on the outcomes of the preclinical trials and subsequent clinical studies, which can be inherently unpredictable. Furthermore, the biotechnology sector often faces fierce competition and regulatory hurdles.
In summary, while Gelteq’s preclinical trial is a significant milestone, indicating potential for disruptive advancements in drug delivery, investors should balance enthusiasm with caution, closely monitoring trial results as well as broader market trends impacting the pharmaceutical industry.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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 40% of marketed drugs and up to 90% of discovery candidates suffer from low solubility and variable bioavailability, leading to higher dosing, greater side effect risk, and inconsistent patient outcomes. By leveraging Gelteq’s formulation expertise, we aim to unlock the full potential of oily and poorly soluble drugs, revive shelved molecules and create new value for global pharmaceutical partners.”
Pharmaceutical companies invest more than USD $4 billion annually in technologies to improve delivery of oily and poorly soluble drugs (1), including solubility-enhancement excipients, lipid-based formulations and lipid nanoparticles with strong projected growth through 2030 (1,2,3). However, there are increasing concerns that emulsifiers in lipid-based drug delivery can disrupt the gut microbiota and compromise gastrointestinal health so it is important to reduce reliance on such additives to enable safer and more effective delivery of oily or poorly soluble drugs (4).
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.
FAQ**
How does Gelteq Limited GELS plan to leverage its proprietary formulation technology to address the solubility challenges faced by over 40% of marketed drugs and 90% of discovery candidates in the pharmaceutical industry?
What specific advantages does Gelteq Limited GELS expect to achieve in terms of patient outcomes and side effects by reducing reliance on emulsifiers in its gel-based oral delivery solutions?
Can you elaborate on Gelteq Limited GELS's plans for pipeline salvage and lifecycle extension, and how these strategies will benefit pharmaceutical partners facing solubility and bioavailability issues?
What metrics or results will Gelteq Limited GELS focus on during the preclinical animal trial to demonstrate the effectiveness of its formulation technology for oily and poorly soluble drugs?
**MWN-AI FAQ is based on asking OpenAI questions about Gelteq Limited (NASDAQ: GELS).
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