FDA approves Novo Nordisk’s oral Wegovy pill for weight management and cardiovascular risk reduction
Approval covers once-daily oral semaglutide 25 mg based on OASIS and SELECT trial data
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Wegovy pill, a once-daily oral semaglutide 25 mg, to reduce excess body weight and support long-term weight maintenance, 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 FDA approval is based on data from the OASIS trial programme and the SELECT trial. In the OASIS 4 trial, oral semaglutide 25 mg taken once daily demonstrated a mean weight loss of 16.6 per cent 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 was similar to that of injectable Wegovy 2.4 mg. In addition, one in three participants experienced 20 per cent or greater weight loss in the OASIS 4 trial. The safety and tolerability profile of semaglutide observed with the Wegovy pill in the OASIS 4 trial was comparable to previous trials of semaglutide for weight management.
Commenting on the approval, Mike Doustdar, President and Chief Executive Officer of Novo Nordisk, said: “The pill is here. With today’s approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection. As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey. No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy pill, and we are very excited for what this will mean for patients in the US”.
Novo Nordisk expects to launch the Wegovy pill in the United States in early January 2026. The company has also submitted oral semaglutide 25 mg once daily for obesity to the European Medicines Agency and other regulatory authorities during the second half of 2025.