Posted by Michael Wonder on 03 May 2025
FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity
2 May 2025 - The FDA filing is based on the results of the Phase 3 OASIS 4 trial that evaluated oral semaglutide 25 mg in adults with obesity or overweight.
Today, Novo Nordisk announced that the US FDA accepted its new drug application submission for an investigational once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight management in adults living with obesity or overweight with one or more co-morbid conditions and to reduce the risk of major adverse cardiovascular events in adults with overweight or obesity and established cardiovascular disease.
