Novo Nordisk has announced that the European Commission (EC) has approved Wegovy® pill (oral semaglutide 25 mg) for the treatment of adults living with obesity or overweight with at least one weight-related health condition. The once-daily tablet is approved to be used alongside a reduced-calorie diet and increased physical activity.
The approval follows a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which was issued in May 2026.
The decision is a major milestone for obesity treatment in Europe. Wegovy pill becomes the first GLP-1 receptor agonist available as a tablet for weight management across all European Union member states. Until now, GLP-1 medicines for weight loss have mainly been available as injections.
This is the fifth regulatory approval for the oral version of Wegovy, following approvals in the United States, the United Kingdom, the United Arab Emirates and Bahrain.
Mike Doustdar, President and CEO of Novo Nordisk, said the approval provides people living with obesity with another important treatment option. He noted that obesity is a serious long-term disease and that giving patients more treatment choices can improve care. According to Doustdar, many people may find taking a daily tablet easier and more acceptable than using injections, making it simpler to start and continue treatment. He described the approval as an important step toward improving long-term health and addressing one of Europe’s biggest public health challenges.
The European Commission’s decision is based on results from the OASIS clinical trial programme, including the Phase 3 OASIS 4 study. The trial evaluated the effectiveness of once-daily oral semaglutide 25 mg in adults with obesity or overweight who also had at least one weight-related medical condition.
In the study, patients taking Wegovy pill together with lifestyle changes achieved an average weight loss of about 17%, compared with around 3% in those receiving a placebo. The trial also showed that about one in three participants lost 20% or more of their body weight, highlighting the medicine’s potential to deliver significant weight reduction.
Novo Nordisk said the safety profile of the oral medicine was consistent with that of injectable semaglutide, which has been used by patients for several years. The rate of treatment discontinuation due to side effects was similar between the Wegovy pill and placebo groups, at 6.9% and 5.9%, respectively.
In addition to approving the oral tablet, the European Commission also approved a 7.2 mg single-dose Wegovy injection pen for people living with obesity, expanding the range of treatment options available in Europe.
Obesity is a growing health concern worldwide and is linked to several serious conditions, including type 2 diabetes, heart disease and high blood pressure. Health experts continue to stress that effective weight management can help reduce the risk of these diseases and improve overall quality of life.
Wegovy pill is already available in the United States, the United Kingdom and the United Arab Emirates. Novo Nordisk said it plans to introduce the medicine in additional countries during the second half of 2026, further expanding access to oral treatment for people living with obesity.