Novo Nordisk today announced that the European Commission (EC) has granted marketing authorisation for Wegovy®️ pill (once-daily oral semaglutide 25 mg) for the treatment of adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity. This follows the positive opinion issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in May 2026
The Wegovy®️ pill approval is a landmark moment in the treatment of obesity in Europe, making it the first GLP-1 receptor agonist available in tablet form for weight management across all European Union member states. It marks the fifth regulatory approval of Wegovy®️ pill, after the US, UK, UAE and Bahrain
“Today’s European Commission approval of Wegovy®️ as a once-daily pill brings another important treatment option to people living with obesity,” said Mike Doustdar, president and CEO of Novo Nordisk. “Obesity is a serious chronic disease, and choice can make a real difference. For many people, a tablet may be a simpler and more acceptable way to start and continue treatment. This is more than a regulatory milestone – it is a step toward better and lasting health for people with obesity and a strong societal response to one of Europe’s most significant health challenges”
The Wegovy®️ pill approval is based on the extensive OASIS clinical trial programme, including OASIS 4, which evaluated once-daily oral semaglutide 25 mg in adults with obesity or overweight with at least one weight-related comorbidity. In the trial, oral semaglutide 25 mg demonstrated clinically meaningful and statistically significant weight loss of approximately 17% compared with 3% with placebo when used alongside lifestyle intervention. Around one in three individuals achieved 20% weight loss or more*.
The safety and tolerability profile of oral semaglutide is consistent with the established injectable semaglutide profile, which is based on many years of patient experience, with adverse-event–related discontinuations nearly comparable to placebo at 6.9% vs 5.9%1*.
The European Commission (EC) also granted approval for Wegovy®️ 7.2 mg injection in a singledose pen for people living with obesity
Wegovy®️ pill is currently available in the US, UK and UAE, and Novo Nordisk is committed to launching Wegovy®️ pill in more countries in the second half of 2026
