European Commission Approves Oral Wegovy Pill for Weight Management in the EU

The European Commission granted marketing authorization on July 15, 2026 for Wegovy pill, a once-daily oral tablet formulation of semaglutide, for weight management in the European Union, Novo Nordisk said. The decision also covered a new single-dose pen delivering the existing injectable Wegovy at a higher 7.2 mg dose. Novo Nordisk described the tablet as the first oral GLP-1 receptor agonist approved for weight management across all EU member states, following earlier approvals of the oral formulation in the United States, United Kingdom, United Arab Emirates and Bahrain.

The EU decision followed a positive opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on May 21, 2026. According to the CHMP's published summary of that opinion, the committee recommended a change to Wegovy's existing marketing authorization to add a new pharmaceutical form and route of administration, tablets for oral use, in four new strengths: 1.5 mg, 4 mg, 9 mg and 25 mg. European Commission decisions on CHMP opinions are typically issued within about 67 days of adoption, according to the same document.

The indication for the oral tablets mirrors the existing injectable Wegovy label. Per the CHMP summary, Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial body mass index of at least 30 kg/m2 (obesity), or at least 27 kg/m2 but under 30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease. The indications for the existing Wegovy solution for injection in pre-filled pens remain unchanged.

Novo Nordisk said the tablet's approval was supported by OASIS 4, a Phase 3b trial in its OASIS clinical program. The company described OASIS 4 as a 64-week study in 307 adults with obesity, or overweight with at least one weight-related comorbidity. According to Novo Nordisk, participants taking oral semaglutide 25 mg achieved a mean weight loss of approximately 17%, compared with about 3% for placebo, and roughly one in three participants on the oral drug lost at least 20% of body weight. The company reported that discontinuations attributed to adverse events occurred in 6.9% of participants on oral semaglutide, compared with 5.9% on placebo.

Novo Nordisk's president and chief executive, Mike Doustdar, said the approval brings another treatment option to people living with obesity in the EU. The company said this was the fifth regulatory approval of the Wegovy pill globally and that it plans to launch the oral tablet more broadly across Europe in the second half of 2026.

The approval changes semaglutide's regulatory status specifically within the European Union; it does not alter the drug's existing approvals or indications in other jurisdictions, including the United States. Semaglutide remains a prescription-only medicine everywhere it is approved, for the specific indications and populations described in each country's approved label. This report describes the approved indication and the trial figures Novo Nordisk has published and is not medical or dosing guidance.