FDA approval for 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 CV events – Novo Nordisk

Novo Nordisk  announced that the FDA has approved 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 programme 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. Furthermore, one in three people experienced 20% or greater weight loss in the OASIS 4 trial.. The well-known safety and tolerability profile of semaglutide was reaffirmed with the Wegovy  pill in the OASIS-4 trial, which was comparable to previous trials with semaglutide for weight management.

“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,” said Mike Doustdar, president and CEO of Novo Nordisk. “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 US 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.

About the OASIS trial programme
OASIS was a phase III clinical development programme with once-daily oral semaglutide 25 mg and 50 mg in obesity. The global clinical phase III programme consisted of four trials, enrolling approximately 1,300 adults with obesity or overweight with one or more comorbidities. OASIS 4 was a 64-week efficacy and safety phase 3b trial of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity or overweight with one or more comorbidities.