Novo Nordisk’s Wegovy pill has received European Commission approval, becoming the first oral GLP-1 treatment authorised for weight management across the European Union.
The once-daily tablet is intended for adults living with obesity, or adults who are overweight and have at least one related health condition. It offers an alternative to the injectable version of Wegovy, which patients administer once a week.
The approval follows a positive recommendation issued in May by the European Medicines Agency’s Committee for Medicinal Products for Human Use. Novo Nordisk said it plans to introduce the medicine in additional markets during the second half of 2026.
Who can use the Wegovy pill
The Wegovy pill contains 25 milligrams of semaglutide, the same active ingredient used in the injectable version of Wegovy and in Novo Nordisk’s diabetes medicine Ozempic.
The treatment has been approved for adults with a body mass index, or BMI, of at least 30. It can also be prescribed to adults with a BMI between 27 and 30 who have at least one weight-related condition.
These conditions may include type 2 diabetes, high blood pressure, high cholesterol, cardiovascular disease or obstructive sleep apnoea. The medicine must be used alongside a reduced-calorie diet and increased physical activity.
Unlike the weekly injection, the tablet must be taken every day. Patients must take it on an empty stomach after fasting for at least eight hours and wait at least 30 minutes before eating, drinking or taking other medicines.
The tablet will only be available on prescription. Decisions concerning its price, reimbursement and use within public healthcare systems will remain the responsibility of individual EU member states.
Clinical trials showed substantial weight loss
The European authorisation was supported by a phase-three clinical trial examining the effectiveness and safety of oral semaglutide.
Novo Nordisk reported that patients who followed the treatment as planned lost approximately 17% of their body weight on average over 64 weeks. The corresponding reduction among participants receiving a placebo was around 3%.
The European Medicines Agency’s analysis, which included all participants regardless of whether they completed the treatment, found an average weight reduction of 13.61% in the Wegovy group, compared with 2.18% in the placebo group.
More than three quarters of participants receiving Wegovy lost at least 5% of their body weight. The corresponding share among placebo recipients was 30.5%.
The most frequently reported side effects were gastrointestinal problems, including nausea, diarrhoea, constipation, abdominal pain and vomiting. According to the EMA, these effects occurred mainly at the beginning of treatment, while the overall safety profile was similar to that of injectable Wegovy.
Oral obesity drugs could expand the market
The approval gives the Danish pharmaceutical company an early advantage in the emerging European market for oral weight-loss medicines.
GLP-1 medicines imitate a hormone that helps regulate appetite, food intake and blood sugar levels. Until recently, the most effective treatments in the category were primarily administered through injections.
Tablets could attract patients who are reluctant to use needles or who consider daily oral treatment more convenient. Novo Nordisk chief executive Mike Doustdar said the approval provides an additional treatment option and may make obesity medicine more acceptable for some patients.
Novo Nordisk already markets the oral Wegovy treatment in the United States, the United Kingdom and the United Arab Emirates. According to Danish broadcaster TV 2, Bahrain has also authorised the medicine.
The company faces increasing competition from US pharmaceutical group Eli Lilly, whose injectable medicines have gained market share in several countries. Lilly is also developing oral GLP-1 treatments, but its competing weight-loss pill has not yet completed the EU authorisation process.
Novo Nordisk’s shares rose by approximately 3% in Copenhagen after the European decision was announced, according to TV 2. The reaction reflected expectations that the company could launch the medicine relatively quickly across a market of 27 member states.
A higher-dose Wegovy pen was also approved
Alongside the tablet, the European Commission approved a single ready-to-use Wegovy pen containing a higher 7.2-milligram dose.
The higher dose had previously been authorised in the EU, but patients had to administer three separate injections of the standard 2.4-milligram formulation during the same treatment session.
The new pen consolidates the dose into a single weekly injection, simplifying its administration. In a separate clinical trial, patients receiving the higher dose lost an average of 20.7% of their body weight over 72 weeks, compared with 17.5% among those receiving the standard dose.
The two approvals broaden Novo Nordisk’s obesity-treatment portfolio at a time when European health systems are assessing how to finance increasingly popular but costly GLP-1 medicines.
European authorisation does not automatically guarantee immediate access. National authorities must still determine pricing and reimbursement conditions, meaning availability may differ substantially across EU countries.
