BioNxt Solutions Inc. (CSE: BNXT, OTC PINK: XPHYF, FSE: 4XT) reported receiving the active pharmaceutical ingredient (API) for Semaglutide. This allows the company to begin laboratory-scale formulation and testing of its oral dissolvable film (ODF) delivery system.
The company secured high-purity Semaglutide from qualified suppliers. The API’s properties, such as solubility and stability, are crucial for formulation design. BioNxt‘s team will conduct pre-formulation and lab-scale trials to optimize delivery.
Initial research will focus on integrating the drug into the sublingual film, analyzing disintegration time, and ensuring stability. The team will also develop analytical methods to guarantee uniformity, controlled release, and product shelf life.
Hugh Rogers, BioNxt‘s CEO, stated that having the API allows the company to move from theoretical work to practical application. The company aims to gather data to refine the formulation and pursue patent protection in the coming quarter.
All laboratory development is occurring at Gen-Plus GmbH in Munich, Germany. Gen-Plus, a licensed drug developer and manufacturer, provides the necessary GMP-compliant laboratory infrastructure and expertise in polymer science and peptide formulation. Their Munich facility serves as BioNxt‘s central hub for thin film research and early-stage development.
The next steps include completing formulation trials, characterizing peptide stability, and producing initial film prototypes. This work will support a provisional patent filing planned for the third quarter of 2025.
Semaglutide, marketed under the brand names Ozempic and Rybelsus, is a leading GLP-1 receptor agonist for type 2 diabetes and obesity. Global demand for GLP-1 therapies is substantial, with Semaglutide generating over USD 29.3 billion in sales in 2024. BioNxt‘s ODF version aims to improve patient compliance through a non-invasive delivery method. This is the first of several planned GLP-1 therapies using BioNxt‘s ODF platform.
BioNxt Solutions Inc. is a bioscience company focusing on next-generation drug delivery platforms and active pharmaceutical ingredient development. With research in North America and Europe, the company is advancing regulatory approvals and commercialization, particularly in European markets. The company is dedicated to improving healthcare through patient-centric solutions.
The company noted that this press release contains forward-looking information subject to various risks and uncertainties. Actual results may differ materially from expectations. Investors should not place undue reliance on forward-looking statements. Ozempic and Rybelsus are registered trademarks of Novo Nordisk A/S and are not affiliated with BioNxt Solutions Inc.
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