Novo Nordisk Announces The FDA Accepts Filing Application For Oral Semaglutide 25mg, Which If Approved, Would Be The First Oral GLP-1 Treatment For Obesity

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Novo Nordisk hopes to expand Wegovy® label by becoming the first GLP-1 treatment for obesity in a pill
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 overweight1
Novo Nordisk continues to build on 100-year-plus legacy of science and innovation

PLAINSBORO, N.J., May 2, 2025 /PRNewswire/ -- Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) 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 comorbid conditions and to reduce the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease.2 If approved, Wegovy® would become the first oral formulation of a GLP-1 indicated for chronic weight management.

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