Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved the Wegovy pill, a once-daily oral semaglutide 25 mg treatment, to reduce excess body weight, support long-term weight maintenance, and lower the risk of major adverse cardiovascular events.
The decision marks the first approval of an oral glucagon-like peptide-1 (GLP-1) receptor agonist for weight management in the United States.
The approval is based on results from the OASIS clinical trial programme and the SELECT trial.
FDA approves first oral GLP-1 treatment for weight management
In the OASIS 4 trial, adults with obesity or overweight and at least one comorbidity who adhered to treatment with oral semaglutide 25 mg once daily recorded a 16.6% weight loss. The results were reported to be in line with those seen with injectable Wegovy® 2.4 mg.
One in three participants in the OASIS 4 trial achieved weight loss of 20 per cent or more.
The safety and tolerability profile of semaglutide observed in the trial was reported to be consistent with previous studies of semaglutide for weight management.
The Wegovy® pill is the first oral GLP-1 receptor agonist approved for weight management.
Novo Nordisk plans US launch in January 2026
“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,” Mike Doustdar, president and CEO of Novo Nordisk said in a statement.
Novo Nordisk said it expects to launch the Wegovy® pill in the United States in early January 2026.
The company also confirmed that it submitted oral semaglutide 25 mg once daily for obesity to the European Medicines Agency and other regulatory authorities during the second half of 2025.
