BioNxt Solutions Inc. has announced the launch of a feasibility study to develop an oral dissolvable film (ODF) formulation of Semaglutide, marking a significant exploration into alternative delivery methods for the blockbuster GLP-1 receptor agonist currently marketed under brand names Ozempic®, Rybelsus®, and Wegovy®.
The initiative represents a strategic evaluation of BioNxt's proprietary thin film drug delivery platform as a non-invasive, user-friendly alternative to existing 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.
Market Opportunity and Current Limitations
Semaglutide has rapidly emerged as a blockbuster drug for type 2 diabetes and obesity, with growing applications 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 in 2023 and is projected to reach approximately $156.7 billion by 2030, driven by increasing obesity rates and the rising demand for non-insulin therapies.
Despite its clinical success, current Semaglutide formulations present adherence challenges. Most formulations still require weekly injections or large daily oral tablets, which can affect patient compliance. A rapidly dissolving oral thin film promises to address these limitations by offering improved accessibility, convenience, and overall patient experience.
"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."
Study Design and Timeline
The feasibility program encompasses several key components, including pre-formulation screening and platform compatibility assessment, drug loading and film integrity evaluation for peptide stability, and 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.
Platform Expansion Strategy
This project represents a strategic expansion of BioNxt's oral thin film 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. BioNxt's proprietary platforms include Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated Tablets) technologies targeting key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity applications.
