Europe’s medicines regulator has recommended approving a daily oral tablet form of Wegovy for obesity treatment, a move that could make it the first pill-based GLP-1 therapy for weight management authorised in the European Union.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued the recommendation, which now passes to the European Commission for a final decision. If approved, the tablet would join a market currently dominated by weekly injectable treatments — including Wegovy itself, as well as Ozempic, Mounjaro and Zepbound — that have driven a global surge in demand for weight-loss therapies in recent years.
Eli Lilly’s oral weight-loss drug Foundayo (orforglipron) is already available in the United States, signalling a broader industry shift from injectables to pills.
According to the EMA, the Wegovy tablet would be indicated for adults with obesity, and for overweight adults who have at least one weight-related comorbidity — including type 2 diabetes, hypertension, high cholesterol, cardiovascular disease or obstructive sleep apnoea. Treatment must be accompanied by a reduced-calorie diet and increased physical activity.
The tablet is prescription-only and must be taken once daily on an empty stomach, after a minimum of eight hours of fasting. Patients must then wait at least 30 minutes before eating, drinking or taking other medicines.
Unlike the injectable form of Wegovy, which is approved for use in adolescents aged 12 and over, the tablet is intended for adults only.
The CHMP recommendation is based on a phase 3 clinical trial involving 307 adults with obesity or excess weight and at least one related comorbidity. Participants followed a reduced-calorie diet and increased physical activity programme for 64 weeks, receiving either the Wegovy tablet or a placebo. Those taking the pill lost an average of 13.61% of their body weight, compared with 2.18% in the placebo group. Some 76.3% of the Wegovy group lost at least 5% of their body weight, against 30.5% in the placebo group.
The most commonly reported side effects were gastrointestinal and included nausea, diarrhoea, constipation, abdominal pain, dyspepsia and vomiting.
The CHMP recommendation is the final scientific stage before the European Commission issues its decision. Once authorised at EU level, each member state will decide separately on pricing and reimbursement through its national health system.
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