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Semaglutide regulatory milestone set for Q1 2026

Business
02 January 2026

Adalvo will submit its DCP application for Semaglutide on February 13th, 2026, marking a major step forward in expanding access to high-value diabetes treatments.   

Semaglutide, a GLP-1 receptor agonist, is recognized as one of the most transformational therapies of recent years, with proven efficacy in improving glycemic control and supporting weight management in adults with type 2 diabetes mellitus.   

Adalvo’s DCP submission aligns with the end of data exclusivity in major markets, positioning the company for Day-1 launches

Globally, Semaglutide sales were estimated to reach $33-$36Bn in 2024, with three-year CAGR exceeding 42%, underlining rapid market adoption.  

As Semaglutide is already on the market, it comes with a proven supply chain. Given the strong global demand for the therapy, the company has implemented a robust double-sourcing strategy for the active pharmaceutical ingredient (API), drug manufacture, and delivery pen production.  

Semaglutide is Adalvo's seventh peptide and confirms the company's position as holder of the broadest GLP-1 pipeline in B2B Pharma. It includes small molecules, oral and injectable formulations, and both short- and long-acting treatment options. 

To discuss licensing or partnership opportunities within Adalvo’s diabetes portfolio, contact the team today.