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Wegovy® pill approved in the US as first oral GLP-1 for 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 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, 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.
*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
