Wegovy® pill approved in the US as first oral GLP-1for weight management

  • Wegovy® pill showed a mean weight loss of 16.6% in the OASIS 4 trial[1]
  • 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

Dubai, 24 December 2025- 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 trial[2]. 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 theWegovy® pill is similar tothat 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 wascomparable 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 earlyJanuary 2026.Novo Nordisk has submitted oral semaglutide 25 mg once-dailyfor obesityto the European Medicines Agency (EMA) and other regulatory authorities during the second half of2025.

About Novo Nordisk

Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com,Facebook, Instagram, X, LinkedIn andYouTube.

*CV death, non-fatal myocardial infarction, or non-fatal stroke

[1]Based on the trial product estimand: treatment effect if all people adhered to treatment

[2]Supported with data from the STEP trial programme and the PIONEER PLUS trial