European Commission approves oral Wegovy, the pill's fifth regulatory clearance

The European Commission has approved the Wegovy pill, a once-daily oral semaglutide for weight management in adults, giving the drug its fifth regulatory approval worldwide ^[1]. Novo Nordisk said it plans to introduce the tablet in more countries in the second half of 2026 ^[1][2].

What was approved

The decision covers adults with a body mass index of at least 30 kg/m², or at least 27 kg/m² with one or more weight-related conditions such as cardiovascular disease, type 2 diabetes or obstructive sleep apnoea. The tablet is intended for use alongside a reduced-calorie diet and increased physical activity ^[1][2].

The European Commission approval makes Wegovy the first GLP-1 receptor agonist available in tablet form for weight management across all European Union member states ^[1]. The oral version covers four strengths — 1.5 mg, 4 mg, 9 mg and 25 mg — and is taken once daily on an empty stomach ^[2].

One restriction stands out: the tablets will be available on prescription to adults only, while the Wegovy injection is cleared for people over 12 ^[2]. Wegovy remains under additional monitoring in the EU ^[2].

The approval follows a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use and earlier authorizations in the United States, the U.K., the United Arab Emirates and Bahrain ^[1][2].

Trial results behind the approval

The European approval was supported by the OASIS clinical trial program, including the OASIS 4 study of once-daily oral semaglutide 25 mg in adults with obesity or overweight and at least one weight-related condition ^[1].

Participants taking the drug lost approximately 17% of their body weight, compared with about 3% for those on placebo, when combined with lifestyle interventions, according to the company. Around one-third of treated participants lost 20% or more ^[1].

Discontinuation rates due to adverse events were 6.9% for oral semaglutide compared with 5.9% for placebo ^[1]. A Phase 3 trial with 307 participants found the safety profile of the daily tablets similar to the injections, with side effects mainly gastrointestinal symptoms and nausea occurring at the start of treatment ^[2].

The European Commission also approved a Wegovy 7.2 mg injection in a single-dose pen for obesity in the same decision ^[1].

Why it matters for patients

Semaglutide has been available as an injection under the Wegovy brand and as a tablet under other brand names with different approved uses. This decision adds a tablet form specifically cleared for weight management in Europe, following US clearance of the same pill ^[1].

For patients weighing an oral option against an injection, the practical differences are the routine — once daily, on an empty stomach — and the age limit: adults only, unlike the injectable version ^[2]. Reported side effects are similar to those of the injections ^[2].

What people in the US will pay for the pill is not addressed by the European decision, and no US pricing or insurance changes tied to this approval have been reported. Whether the European approval changes US labeling, supply or availability has not been disclosed.

What happens next

Novo Nordisk said it plans to launch the tablets in select EU markets in the second half of 2026 and to introduce the treatment in additional countries during the same period ^[1][2]. Discussions about price and reimbursement will take place once the extension has been granted, taking into account individual national health systems ^[2].

Other companies are pursuing the same category. AstraZeneca is moving its own oral GLP-1 receptor agonist, elecoglipron, into Phase 3 trials after Phase 2b results in obesity and type 2 diabetes ^[2].