The European Commission authorized Novo Nordisk's Wegovy oral semaglutide 25 mg for weight management, making it the first GLP-1 tablet approved across EU member states. The decision is based on the OASIS 4 trial showing 17% weight loss. This is the fifth approval for the Wegovy pill, with launch…
The European Commission granted marketing authorization on July 17, 2026, for Novo Nordisk's Wegovy pill. This once-daily oral semaglutide 25 mg formulation is approved for the treatment of adults with obesity or overweight who have at least one weight-related comorbidity. The medication is intended for use as an adjunct to a reduced-calorie diet and increased physical activity. The European Commission's authorization follows a review of safety and efficacy data, allowing Novo Nordisk to market Wegovy pill across all EU member states for the specified indication.
This approval makes Wegovy the first GLP-1 receptor agonist available in tablet form for weight management across all 27 European Union member states. It represents the fifth regulatory approval for the Wegovy pill, following prior authorizations in the United States, the United Kingdom, the United Arab Emirates, and Bahrain.
The European Commission's decision is based on data from the OASIS clinical trial program, including the OASIS 4 study. The OASIS 4 trial specifically evaluated once-daily oral semaglutide 25 mg in adults with obesity or overweight and at least one weight-related comorbidity. Results demonstrated that oral semaglutide 25 mg produced a clinically meaningful and statistically significant weight loss of approximately 17 percent. In the placebo group, weight loss was approximately 3 percent. Both groups received lifestyle intervention alongside treatment. Additionally, about one in three participants in the semaglutide group achieved a weight loss of 20 percent or more. The trial's results underscore the efficacy of oral semaglutide as a weight management tool. The approximately 17 percent weight loss observed in the treatment group represents a substantial reduction that can improve obesity-related health outcomes. The fact that one in three participants lost at least a fifth of their body weight further emphasizes the treatment's potential.
In addition to the oral tablet, the European Commission also granted approval for Wegovy 7.2 mg injection in a single-dose pen for people living with obesity. This injectable formulation provides another option for patients who may require or prefer injection therapy.
Novo Nordisk has announced its commitment to launching the Wegovy pill in more countries during the second half of 2026. The company plans to expand availability beyond the initial five markets where the oral formulation has already received regulatory approval.
"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.
Peptides referenced: Semaglutide, GLP-1.
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