Galmed, Entomus Partner to Introduce Sublingual Semaglutide

Galmed Pharmaceuticals Ltd. announced it has signed a binding term sheet with Entomus s.r.o. for the license and development of a new sublingual formulation of semaglutide using its proprietary Self-Emulsifying Drug Delivery System (SEDDS), amid expiring patent protections in markets such as Mexico.  The agreement outlines the development and commercialization framework, with a definitive contract expected within 90 days.

With patent protections for Semaglutide beginning to expire in significant markets such as India, Brazil, and Mexico as early as 2026, Galmed aims to capitalize on the growing demand for innovative GLP-1 therapies in countries with rising rates of obesity and type 2 diabetes mellitus (T2DM). “The proposed transmucosal administration route could potentially enhance bioavailability in comparison with Rybelsus and reduce the daily dose of semaglutide,” said Allen Baharaff, President and CEO, Galmed. He noted the goal is to offer a non-invasive alternative to existing injectable and oral treatments, with the potential for improved patient compliance.

Semaglutide, a GLP-1 receptor agonist, has emerged as a key treatment for Type 2 diabetes, obesity, and related cardiometabolic conditions. Injectable forms such as Ozempic and Wegovy and the oral version Rybelsus are widely used, but challenges remain around patient acceptance and drug metabolism. Injectable versions, while avoiding gastrointestinal degradation, can cause discomfort, while oral formulations can suffer from reduced efficacy due to the first-pass effect in the liver, states report.

Galmed's approach seeks to bypass these limitations by enabling absorption directly through the oral mucous membranes, potentially offering greater bioavailability and a steadier pharmacokinetic profile. The company's SEDDS technology, delivered via orally dispersible films, is designed to allow peptides like semaglutide and liraglutide to enter systemic circulation without requiring injection or extensive gastrointestinal processing.

The GLP-1 therapeutics market is expanding rapidly. Analysts from Jefferies project it will surpass US$120 billion globally by 2030, with expected ex-US peak sales around US$20 billion by 2032, states report.