Wegovy®️ pill showed a mean weight loss of 16.6% in the OASIS 4 trial
Wegovy®️ pill is indicated to reduce excess body weight and maintain weight reduction long-term and to reduce the risk of major adverse cardiovascular events*
Novo Nordisk expects to launch Wegovy®️ pill in the US in early January 2026
Novo Nordisk today announced that the US Food and Drug Administration (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 trial2. 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 comorbidities1. 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 trial1. 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, oncedaily 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.
