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Bionxt begins FS for semaglutide oral thin film

2025-06-23 09:57 ET - News Release

Mr. Hugh Rogers reports

BIONXT LAUNCHES FEASIBILITY STUDY FOR SEMAGLUTIDE ORAL THIN FILM AS ALTERNATIVE TO INJECTION/TABLETS

Bionxt Solutions Inc. has launched 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, chief executive officer 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 analogue 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 $24.4-billion (U.S.) in 2023 and is projected to reach approximately $156.7-billion (U.S.) 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:

  • Preformulation 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, preformulation 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 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 health care by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.

Bionxt is listed on the Canadian Securities Exchange under the symbol BNXT and on the OTC (over-the-counter) market under the symbol BNXTF and trades in Germany under WKN: A3D1K3.

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