US EditionFDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity
- Novo Nordisk announced on May 2, 2025, in Plainsboro, N.J., that the FDA accepted its NDA for a once-daily, 25 mg oral Wegovy formulation for obesity treatment.
- This filing followed the phase 3 OASIS 4 trial, which tested oral semaglutide 25 mg in 307 adults with obesity or overweight without diabetes over 64 weeks of treatment plus follow-up.
- The trial randomized participants 2:1 to oral semaglutide or placebo and targeted chronic weight management and reduction of major cardiovascular events in adults with comorbidities.
- Novo Nordisk announced that the FDA has acknowledged its New Drug Application for an oral form of Wegovy�, marking a potential milestone as the first GLP-1 therapy available in pill form for obesity treatment. The company is eager to collaborate with regulators throughout the approval process.
- If approved by Q4 2025, Wegovy would become the first oral GLP-1 agent indicated for chronic weight management, expanding treatment options for the 40% of U.S. Adults living with obesity.
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FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity
Novo Nordisk hopes to expand Wegovy® label by becoming the first GLP-1 treatment for obesity in a pillThe FDA filing is based on the results of the phase 3 OASIS 4 trial that evaluated oral semaglutide 25 mg in adults…
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