Novo Nordisk today announced that the European Commission (EC) has granted marketing authorisation for Wegovy®️ pill (onc
e-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
e-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 2026The 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
