FDA approves Wegovy pill, oral semaglutide 25 mg, for weight management

Novo Nordisk/Wegovy (semaglutide)

The FDA approved Wegovy pill, once-daily oral semaglutide 25 mg, as the first oral GLP-1 therapy for weight management. OASIS 4 showed 16.6% mean weight loss when patients adhered to treatment. Novo Nordisk planned a U.S. launch in early January 2026.

• First oral GLP-1 approved for chronic weight management in adults with obesity or overweight.
• OASIS 4 trial: 16.6% weight loss on treatment versus 2.7% on placebo (treatment-adherence estimand).
• All-participants analysis showed 13.6% weight loss versus 2.4% on placebo.
• Approved for reducing cardiovascular risk in patients with established heart disease.