Novo Nordisk received approval from the U.S. FDA for the Wegovy pill (once-daily oral semaglutide 25 mg) to reduce excess body weight and maintain weight reduction long term and to reduce the risk of major adverse cardiovascular events.

The Wegovy pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management. The approval is based on the OASIS trial program and the SELECT trial. In the OASIS 4 trial, oral semaglutide 25 mg taken once daily demonstrated 16.6% mean weight loss when treatment was adhered to in adult participants with obesity or overweight with one or more comorbidities. The weight loss achieved with the Wegovy pill is similar to that of injectable Wegovy 2.4 mg. One in three people experienced 20% or greater weight loss in the OASIS 4 trial. The safety and tolerability profile of semaglutide was comparable to previous trials with semaglutide for weight management.

Novo Nordisk expects to launch the Wegovy pill in the U.S. in early January 2026. Novo Nordisk has submitted oral semaglutide 25 mg once-daily for obesity to the European Medicines Agency (EMA) and other regulatory authorities during the second half of 2025.