Novo Nordisk picks up Europe’s first approval for oral GLP-1 in weight management

The European Commission has granted marketing authorization for Wegovy pill (once-daily oral semaglutide 25 mg), making Denmark-based Novo Nordisk the first company to offer an approved oral GLP-1 receptor agonist for weight management across EU member states. The Wegovy pill EU approval, which follows a positive CHMP opinion issued in May 2026, represents a meaningful shift in how obesity pharmacotherapy may be delivered in Europe by removing the injection barrier that has limited uptake of the injectable formulation for some patients.

The EC simultaneously approved Wegovy 7.2 mg injection in a single-dose ready-to-use pen, following on from the US FDA’s previously reported clearance for the higher-dose formulation. The oral approval marks the fifth regulatory authorization for the Wegovy pill, following the US, UK, UAE, and Bahrain.

The approved indication covers adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity, used as an adjunct to a reduced-calorie diet and increased physical activity. The once-daily pill is administered at 25 mg and is formulated with SNAC (sodium N-[8-(2-hydroxybenzoyl)amino]caprylate), an absorption-enhancing excipient that Novo Nordisk acquired outright when it purchased Emisphere Technologies for USD 1.8 billion in 2020. SNAC facilitates gastric absorption of the peptide by transiently raising local pH and promoting transcellular permeation — enabling clinically meaningful oral bioavailability of a molecule that would otherwise be degraded in the gastrointestinal tract.

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The approval rests primarily on OASIS 4, a 64-week Phase III efficacy and safety trial evaluating once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity or overweight and at least one comorbidity. The primary endpoint was percent change in body weight from baseline. Participants receiving the active treatment achieved approximately 17% mean weight loss, compared with approximately 3% in the placebo group, based on the trial product estimand; around one in three participants achieved weight loss of 20% or more. Adverse-event-related discontinuations were 6.9% with semaglutide versus 5.9% with placebo, a profile consistent with the established injectable semaglutide experience.

The EU approval consolidates Novo Nordisk’s position as the only company currently offering both an approved oral and injectable GLP-1 therapy for obesity in Europe.


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