European Commission approves first GLP-1 weight loss pill for obesity treatment
Novo Nordisk’s once-daily Wegovy pill becomes the first GLP-1 receptor agonist tablet approved in the European Union for weight management. The European Commission also clears the higher-dose Wegovy 7.2 mg injection.
The European Commission has granted marketing authorisation for Novo Nordisk’s once-daily Wegovy pill (oral semaglutide 25 mg), making it the first glucagon-like peptide-1 (GLP-1) receptor agonist tablet approved across the European Union for the treatment of obesity and overweight.
The approval covers adults with obesity, defined as a body mass index (BMI) of 30 kg/m² or higher, or those who are overweight, with a BMI of 27 kg/m² or higher, and have at least one weight-related comorbidity. The medicine is approved as an addition to a reduced-calorie diet and increased physical activity.
GLP-1 receptor agonists are medicines that mimic a naturally occurring hormone involved in regulating appetite and food intake.
The decision follows a positive opinion issued in May 2026 by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
The approval marks the fifth regulatory clearance for the Wegovy pill, following authorisations in the United States, the United Kingdom, the United Arab Emirates and Bahrain.
Clinical trial findings
The approval is based on the OASIS clinical trial programme, a Phase III clinical development programme evaluating once-daily oral semaglutide for obesity.
A Phase III trial is a large clinical study designed to confirm whether a medicine is effective and safe before regulatory approval.
The OASIS 4 trial evaluated oral semaglutide 25 mg in adults with obesity or overweight and at least one weight-related comorbidity. According to Novo Nordisk, participants receiving the medicine alongside lifestyle interventions achieved an average weight loss of about 17%, compared with 3% in the placebo group. Approximately one in three participants achieved weight loss of 20% or more.
The company said the safety and tolerability profile of oral semaglutide was consistent with the established injectable form of semaglutide. Adverse event-related treatment discontinuation occurred in 6.9% of participants receiving oral semaglutide, compared with 5.9% in the placebo group.
The global OASIS programme included four trials involving approximately 1,300 adults with obesity or overweight and one or more weight-related comorbidities. OASIS 4 was a 64-week Phase IIIb efficacy and safety trial involving 307 participants.
Higher-dose injection also approved
The European Commission also approved Wegovy 7.2 mg injection in a single-dose pen for people living with obesity.
According to Novo Nordisk, the higher-dose injection demonstrated average weight loss of 21%.
Company plans wider rollout
Mike Doustdar, President and Chief Executive Officer of Novo Nordisk, said the approval provides another treatment option for people living with obesity.
“Today’s European Commission approval of Wegovy as a once-daily pill brings another important treatment option to people living with obesity,” Doustdar said. “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.”
Wegovy pill is currently available in the United States, the United Kingdom and the United Arab Emirates. Novo Nordisk said it plans to launch the medicine in additional countries during the second half of 2026.
