semaglutide oral dissolvable film (BNT24005) / BioNxt - LARVOL DELTA

BioNxt Advances GLP-1 Sublingual Semaglutide ODF Program with Next Stage of Delivery Development Underway (ACCESS Newswire) - "BioNxt's Semaglutide ODF program is designed to evaluate a needle-free, patient-friendly thin-film delivery format for GLP-1 receptor agonists....BioNxt has advanced the Semaglutide ODF program through feasibility evaluation and early formulation work and is now progressing the program into its next stage of pharmaceutical development. Current activities include formulation optimization, analytical method work, compatibility testing, placebo and active thin-film development, and preparation for additional proof-of-concept, preclinical, and formulation validation activities."

Preclinical • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

BioNxt Solutions Inc...is pleased to announce that its Semaglutide oral dissolvable film ('ODF') program has entered the active pharmaceutical development phase in collaboration with German drug development partner Gen-Plus GmbH. (ACCESS Newswire) - "The first phase of the Semaglutide development program is expected to span approximately six to nine months and focuses on formulation development, development of analytical methods, analytical characterization, compatibility testing, and proof-of-concept evaluation activities...Initial work completed or currently underway includes theoretical formulation studies for sublingual Semaglutide administration, sourcing of active pharmaceutical ingredients and excipients, development of analytical methods for raw materials and finished formulations, compatibility testing of formulation components, and placebo thin-film studies evaluating dissolution and film performance characteristics...Proof-of-concept studies are expected to begin following receipt of Semaglutide API materials anticipated later this year."

Licensing / partnership • New trial • Obesity • Type 2 Diabetes Mellitus

BioNxt Solutions Inc…is pleased to announce the successful completion of proof-of-concept trials for its Semaglutide oral dissolvable film (“ODF“) program at Vektor Pharma TF GmbH (“Vektor Pharma“), the Company’s wholly owned German subsidiary. (ACCESS Newswire) - "The prototypes demonstrated rapid disintegration, homogeneous film quality, good processability during manufacturing, and favorable mechanical properties. These results confirm the suitability of BioNxt's thin film technology for complex peptide formulations and provide a solid foundation for further development...BioNxt is preparing to file a patent application for the Semaglutide ODF in the coming months...These efforts are expected to continue through late 2025 and will culminate in a preclinical animal study anticipated to begin in early 2026."

Preclinical • Obesity • Type 2 Diabetes Mellitus

BioNxt Launches Feasibility Study for Semaglutide Oral Thin Film as Alternative to Injection/Tablets (ACCESSWIRE) - "BioNxt Solutions Inc...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."

Clinical • Obesity • Type 2 Diabetes Mellitus