Key Highlights
- The European Commission has approved Novo Nordisk’s once-daily oral semaglutide 25 mg tablet, making Wegovy the first GLP-1 receptor agonist available in pill form for weight management across all EU member states, following prior approvals in the US, UK, UAE, and Bahrain.
- The oral formulation delivered approximately 17% mean weight loss in the pivotal OASIS 4 trial versus 3% on placebo, with roughly one in three patients reaching 20% or greater weight loss, and a safety profile broadly consistent with the injectable version.
- Alongside the pill, the EC also cleared a new single-dose, ready-to-use 7.2 mg Wegovy injection pen shown to deliver around 21% weight loss, giving European patients and clinicians two higher-efficacy options as Novo Nordisk plans further country launches through the second half of 2026.
A Landmark Shift From Injection to Tablet
The European Commission’s authorization marks the first time a GLP-1 receptor agonist has been available in tablet form for weight management anywhere in the EU. The approval covers adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) who also have at least one weight-related health condition, to be used alongside a reduced-calorie diet and increased physical activity. It represents the fifth global regulatory clearance for the oral formulation, reinforcing Novo Nordisk’s push to broaden access beyond injectable therapy.
Clinical Evidence Behind the Approval
The decision rests on the OASIS phase 3 program, most notably OASIS 4, a 64-week trial that enrolled adults with obesity or overweight and at least one comorbidity. Participants on the oral tablet achieved meaningful weight reduction far exceeding placebo, and discontinuation rates linked to side effects were only modestly higher than placebo, suggesting a tolerability profile in line with years of experience with injectable semaglutide.
A Higher-Dose Pen Adds Flexibility
Alongside the pill, regulators also approved a single-dose, ready-to-use pen for the 7.2 mg injectable dose of Wegovy, which demonstrated even greater weight loss in trials. Offering both a tablet and a higher-dose, simplified injection format gives physicians more ways to tailor obesity treatment to individual patient needs and preferences.
Leadership Frames It as a Public Health Milestone
Novo Nordisk’s leadership described the approval as more than a regulatory achievement, positioning it as a meaningful response to obesity as a serious chronic disease affecting a large share of the European population. The company has signaled plans to expand the oral pill’s availability to additional countries through the remainder of 2026, building on its existing rollout in the US, UK, and UAE.
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