BAGSVÆRD, Denmark, July 15, 2026
Novo Nordisk has achieved a major regulatory milestone after the European Commission (EC) granted marketing authorization for Wegovy® pill (oral semaglutide 25 mg), making it the first oral GLP-1 receptor agonist approved in the European Union for weight management. The EC also approved the Wegovy® 7.2 mg single-dose, ready-to-use injection pen, expanding treatment options for adults living with obesity or overweight with at least one weight-related comorbidity. The landmark decision follows the positive recommendation issued earlier this year by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and reinforces Novo Nordisk’s leadership in the rapidly growing obesity therapeutics market. The approval allows the once-daily oral formulation to be used alongside a reduced-calorie diet and increased physical activity, offering patients across the European Union an innovative alternative to injectable GLP-1 therapies. As obesity continues to represent one of Europe’s most significant public health challenges, the latest approval is expected to broaden access to evidence-based medical treatment while supporting long-term weight management and cardiovascular health.
First Oral GLP-1 Therapy Expands Obesity Treatment Options
The newly approved Wegovy® pill contains once-daily oral semaglutide 25 mg, becoming the first tablet formulation of a GLP-1 receptor agonist authorized for chronic weight management throughout the European Union. The approval covers adults with a body mass index (BMI) of 30 kg/m² or greater, or 27 kg/m² or greater with at least one weight-related comorbidity, including conditions such as hypertension, dyslipidemia, cardiovascular disease, obstructive sleep apnea, or prediabetes. Clinical evidence supporting the authorization comes from Novo Nordisk’s comprehensive OASIS clinical development program, particularly the OASIS 4 trial, which demonstrated significant and sustained weight reduction in adults living with obesity or overweight. According to the company, the oral therapy demonstrated approximately 17% mean weight loss while also supporting established cardiovascular benefits, providing patients with a convenient non-injectable treatment option that may improve treatment acceptance, adherence, and long-term disease management. The approval marks the fifth global regulatory authorization for the oral formulation following approvals in the United States, United Kingdom, United Arab Emirates, and Bahrain.
Higher-Dose Wegovy Pen Strengthens Novo Nordisk’s Portfolio
Alongside the oral formulation, the European Commission also approved the Wegovy® 7.2 mg single-dose pen, providing healthcare professionals with an additional treatment option capable of delivering substantial weight reduction in eligible patients. Clinical data supporting the higher-dose injectable formulation demonstrated approximately 21% mean weight loss, further expanding Novo Nordisk’s comprehensive obesity treatment portfolio. Company leadership described the dual approvals as an important advancement for people living with obesity by increasing treatment choice while recognizing that patient preferences differ between oral and injectable therapies.
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With obesity affecting millions of individuals across Europe and contributing significantly to diabetes, cardiovascular disease, and numerous chronic health conditions, the availability of both oral and injectable GLP-1 therapies is expected to improve personalized treatment strategies. The approvals further reinforce Novo Nordisk’s continued investment in obesity research, precision medicine, and innovative metabolic disease therapies. As healthcare systems increasingly recognize obesity as a chronic disease requiring long-term medical management, the introduction of the first oral GLP-1 therapy in the European Union represents a significant advancement in pharmaceutical innovation. The latest regulatory milestone strengthens Novo Nordisk’s global leadership in GLP-1-based obesity care while providing physicians and patients with broader therapeutic choices designed to improve long-term clinical outcomes and quality of life.
Source: Novo Nordisk press release
