BioNxt Launches Feasibility Study for Semaglutide Oral Thin Film as Alternative to Injection/Tablets

Rhea-AI Summary

BioNxt Solutions (BNXTF) has launched a feasibility study to develop an oral dissolvable film formulation of Semaglutide, currently marketed as Ozempic, Rybelsus, and Wegovy. The study aims to evaluate BioNxt's proprietary thin film technology as a non-invasive alternative to injectable and tablet-based GLP-1 therapies. The global GLP-1 receptor agonist market, valued at $24.4 billion in 2023, is projected to reach $156.7 billion by 2030. The study will focus on pre-formulation screening, drug loading evaluation, and generating data for patent filings. BioNxt expects to receive the Semaglutide API in July, with plans for a provisional patent filing in Q3 2025. This initiative represents the company's strategic expansion into the growing GLP-1 therapeutics market, targeting improved patient adherence and comfort in diabetes and obesity treatment.

Positive

• Targeting a rapidly growing GLP-1 market projected to reach $156.7 billion by 2030
• Potential to improve patient experience through non-invasive drug delivery alternative
• Strategic expansion into high-value therapeutics with established market demand
• Patent filing planned for Q3 2025 to protect intellectual property

Negative

• Study is in early feasibility stage with no guaranteed success
• API delivery not yet received, creating potential timeline uncertainties
• Will face significant competition from established pharmaceutical companies
• No immediate revenue impact as development is in preliminary phases

VANCOUVER, BC / ACCESS Newswire / June 23, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC:BNXTF)(FSE:BXT), is pleased to announce the launch of a feasibility study for the development of an oral dissolvable film (ODF) formulation of Semaglutide, a GLP-1 receptor agonist currently marketed globally under the brand names Ozempic®, Rybelsus®, and Wegovy®.

This initiative marks a significant step in evaluating BioNxt's proprietary thin film drug delivery platform as a non-invasive, user-friendly alternative to injectable and tablet-based GLP-1 therapies. The study is designed to assess the compatibility of Semaglutide with BioNxt's ODF technology and generate early data to inform formulation optimization and intellectual property strategy.

"We believe there is a compelling opportunity to rethink how complex molecules like Semaglutide are delivered," said Hugh Rogers, CEO at BioNxt. "Our oral thin film platform is engineered to improve patient adherence and comfort, and this feasibility study is an important first step in bringing a new delivery option to market."

Semaglutide: A High-Growth Market Segment

Semaglutide is a GLP-1 analog that has rapidly become a blockbuster drug for type 2 diabetes and obesity, with growing use in cardiovascular risk reduction. According to a 2024 report by Data Bridge Market Research, the global GLP‑1 receptor agonist market was valued at USD 24.4 billion in 2023 and is projected to reach approximately USD 156.7 billion by 2030, driven by increasing obesity rates and the rising demand for non‑insulin therapies.

Despite its success, most current Semaglutide formulations still require weekly injections or large daily oral tablets, which can affect patient adherence. A rapidly dissolving oral thin film promises a significant boost in accessibility, convenience, and overall patient experience.

Study Objectives

The feasibility program includes:

• Pre-formulation screening and platform compatibility assessment

• Drug loading and film integrity evaluation for peptide stability

• Generation of early-stage technical data to support patent filings

The feasibility study is currently in the planning phase, with receipt of the Semaglutide active pharmaceutical ingredient (API) anticipated in July. Upon delivery, pre-formulation activities and laboratory-scale formulation trials will be initiated. Subsequent prototype development and characterization are expected to support a provisional patent filing in the third quarter of 2025.

This project represents a strategic expansion of BioNxt's oral thin film (ODF) drug delivery platform, which is designed to enable the non-invasive administration of high-value therapeutics. Semaglutide is the first in a planned series of GLP-1 receptor agonists being developed using this technology. The platform is particularly well-suited for peptide-based compounds and holds significant potential to support additional thin film solutions across the rapidly growing class of GLP-1 therapies targeting diabetes, obesity, and related metabolic disorders.

About BioNxt Solutions Inc.

BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company's proprietary platforms - Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated Tablets) - target key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity.

With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.

BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets: BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit www.bionxt.com.

Investor Relations & Media Contact

Hugh Rogers, Co-Founder, CEO and Director
Email: investor.relations@bionxt.com
Phone: +1 778.598.2698

Web: www.bionxt.com

LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt

Cautionary Statement Regarding "Forward-Looking" Information

This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian securities laws (collectively, "forward-looking information"). Forward-looking information includes, but is not limited to, statements related to the Company's oral thin film (ODF) development program for Semaglutide; the anticipated timing and outcomes of formulation studies; the potential for future patent filings; market growth projections; and the broader applicability of the Company's drug delivery technologies.

Forward-looking information is based on management's reasonable assumptions, expectations, estimates, and projections as of the date of this press release. Such statements are subject to various known and unknown risks, uncertainties, and other factors - many of which are beyond the Company's control - that may cause actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking information. These risks and uncertainties include, but are not limited to: scientific and technical development risks; manufacturing and scalability risks; intellectual property protection; regulatory approval processes; competition in the GLP-1 drug market; and general economic, financial, and market conditions.

Readers are cautioned not to place undue reliance on forward-looking information. Although the Company believes the expectations and assumptions reflected in such statements are reasonable, there can be no assurance that they will prove to be correct. Except as required by applicable securities laws, the Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.

Ozempic®, Rybelsus®, and Wegovy® are registered trademarks of Novo Nordisk A/S and are not affiliated with or developed by BioNxt Solutions Inc.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

FAQ

What is BioNxt's (BNXTF) new development project for Semaglutide?

BioNxt is developing an oral dissolvable film formulation of Semaglutide as an alternative to injectable and tablet forms of the drug currently marketed as Ozempic, Rybelsus, and Wegovy.

What is the market potential for BioNxt's Semaglutide oral film?

The global GLP-1 receptor agonist market is projected to grow from $24.4 billion in 2023 to $156.7 billion by 2030, representing significant market potential.

When does BioNxt expect to file a patent for their Semaglutide oral film?

BioNxt plans to file a provisional patent in the third quarter of 2025, following completion of prototype development and characterization.

What are the main objectives of BioNxt's Semaglutide feasibility study?

The study aims to assess platform compatibility, evaluate drug loading and film integrity for peptide stability, and generate technical data for patent filings.

How could BioNxt's oral film technology improve current Semaglutide treatment?

The oral dissolvable film aims to improve patient adherence and comfort by providing a non-invasive alternative to weekly injections or large daily tablets.