Gelteq Announces Commencement of Preclinical Trial Targeting Oil Soluble Drug Market with Novel Delivery Platform

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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

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 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

1. 360iResearch. (2024). Solubility enhancement excipients market: Global forecast 2025–2032 (Report ID: 5675273). Research and Markets.
2. Allied Market Research. (2025). Targeted liposomes drug delivery market: Global opportunity analysis and industry forecast, 2023–2032 (Report ID: A12661).
3. Grand View Research. (2025). Lipid nanoparticle market, 2025–2030 (Report ID: GVR-4-68040-547-5).
4. 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

What did Gelteq (GELS) announce on October 23, 2025?

Gelteq announced it started a preclinical animal trial of its gel-based oral formulation for oily and poorly soluble drugs with Monash University.

What is the goal of Gelteq's preclinical trial for GELS?

To evaluate the company's proprietary formulation technology to improve oral delivery of oily and poorly soluble drugs.

How large is the market problem Gelteq (GELS) aims to address?

The announcement cites that >40% of marketed drugs and up to 90% of discovery candidates have low solubility, and the industry spends > USD $4 billion yearly on delivery technologies.

Who is Gelteq partnering with for the GELS preclinical study?

The study is being conducted with Monash University Institute of Pharmaceutical Science.

What commercial paths did Gelteq outline if the GELS trial succeeds?

Gelteq said potential options include pipeline salvage, lifecycle extension, and reduced API dose size to improve adherence.

Does Gelteq (GELS) have human trial results from this technology yet?

No; the announcement describes a preclinical animal trial, so human data are not yet available.