The European Commission approves Wegovy pill (oral semaglutide 25 mg), the first oral GLP-1 therapy for obesity in the EU, supported by Phase 3 OASIS 4 trial data.
Written By: Mayuresh Salvi, PharmD
Reviewed By: Pharmacally Editorial Team
The European Commission has granted marketing authorisation for Wegovy® pill (oral semaglutide 25 mg), making it the first oral glucagon-like peptide-1 (GLP-1) receptor agonist approved in the European Union for chronic weight management. The approval is indicated for adults with obesity (body mass index [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. The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in May 2026. The European Union becomes the fifth market to approve Wegovy® pill, following the United States, the United Kingdom, the United Arab Emirates, and Bahrain.
Study Design
The approval is supported by the Phase 3 OASIS clinical development programme (NCT05564117) evaluating once-daily oral semaglutide 25 mg and 50 mg in obesity. The global programme enrolled approximately 1,300 adults with obesity or overweight and one or more weight-related comorbidities. The pivotal OASIS 4 trial was a 64-week, randomised, double-blind, placebo-controlled Phase 3b study involving 307 adults with obesity or overweight and at least one weight-related comorbidity. Participants received once-daily oral semaglutide 25 mg or placebo alongside a reduced-calorie diet and increased physical activity.
The findings supporting the European Commission approval were published in the New England Journal of Medicine by Wharton et al. (2025).
Primary Endpoint
The primary endpoint assessed the percentage change in body weight from baseline at week 64. Participants receiving oral semaglutide 25 mg achieved an average 17% reduction in body weight compared with 3% in the placebo group, demonstrating clinically meaningful and statistically significant weight loss when combined with lifestyle intervention. Approximately one in three participants treated with oral semaglutide achieved at least 20% weight loss, supporting its ability to produce substantial and clinically meaningful long-term weight reduction.
Safety Profile
The safety and tolerability profile of oral semaglutide was consistent with the established experience for injectable semaglutide. Gastrointestinal adverse events were the most frequently reported treatment-related events and were generally mild to moderate in severity. Treatment discontinuation due to adverse events occurred in 6.9% of participants receiving oral semaglutide compared with 5.9% in the placebo group, indicating an overall favourable and manageable safety profile.
Regulatory Significance
Alongside the oral formulation, the European Commission also approved Wegovy® 7.2 mg injection in a single-dose ready-to-use pen for adults living with obesity. Clinical studies have shown that the higher-dose injectable formulation can achieve approximately 21% mean weight loss, providing an additional evidence-based treatment option that enables clinicians to tailor therapy according to individual patient needs and preferences. Novo Nordisk also announced plans to launch Wegovy® pill in additional countries during the second half of 2026.
Clinical Implications
Obesity is a chronic, progressive disease associated with an increased risk of cardiovascular disease, type 2 diabetes, chronic kidney disease, obstructive sleep apnoea, and other metabolic complications. The approval of Wegovy® pill introduces the first oral GLP-1 receptor agonist for chronic weight management in the European Union, offering patients who prefer an oral therapy a convenient once-daily alternative. The availability of both oral and injectable formulations expands treatment options and provides clinicians with greater flexibility to individualise therapy based on patient preference, clinical characteristics, adherence potential, and long-term treatment goals.
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About the Writer
Mayuresh Sunil Salvi (Linkedin) is a PharmD professional and healthcare writer with a strong interest in pharmacovigilance, drug safety, and emerging medical research. He is passionate about exploring new drug discoveries, clinical research, and advances in evidence-based medicine. His interests also include ward rounds, prescription audits, and treatment analysis to support rational pharmacotherapy and improved patient care.