UK Approves Europe’s First Oral Wegovy for Weight Management

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Wegovy® pill (semaglutide tablets) for chronic weight management in adults living with obesity or overweight with at least one weight-related condition.

The approval makes the UK the first European country to authorize the oral formulation of Wegovy and introduces the first GLP-1 receptor agonist tablet approved for weight management in the region.

Novo Nordisk expects Wegovy pill to become available through private prescription in the UK within weeks.

Expanding Access to GLP-1 Weight Management Therapy

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that reduces appetite, increases feelings of fullness, and helps lower calorie intake. Until now, semaglutide-based obesity treatment has primarily been available as a once-weekly injection.

The newly approved oral formulation offers a once-daily alternative for adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m² to <30 kg/m²) who have at least one weight-related comorbidity, alongside a reduced-calorie diet and increased physical activity.

The approval comes as obesity continues to place a growing burden on healthcare systems. Novo Nordisk estimates that approximately 15 million people in the UK are living with obesity, while projections suggest that more than two-thirds of adults could be overweight or living with obesity by 2040.

OASIS 4 Demonstrated Clinically Meaningful Weight Loss

The MHRA decision was supported by data from the Phase 3 OASIS 4 trial, a randomized, double-blind, placebo-controlled study evaluating once-daily oral semaglutide 25 mg in 307 adults with obesity or overweight and at least one weight-related condition, without type 2 diabetes.

At 64 weeks, the treatment policy analysis, which assessed outcomes regardless of treatment adherence, showed mean weight loss of 13.6% with semaglutide compared with 2.4% for placebo.

In the on-treatment analysis, which estimated outcomes assuming participants remained on therapy, semaglutide achieved 16.6% weight loss versus 2.7% with placebo.

The study met its co-primary endpoints, including percentage change in body weight and the proportion of participants achieving at least 5% weight loss.

All participants received lifestyle counseling, including a daily 500-calorie deficit and structured physical activity recommendations throughout the study.

Safety Profile Consistent with Injectable Semaglutide

The safety findings were consistent with previous semaglutide studies. Gastrointestinal adverse events were the most frequently reported side effects, including nausea, vomiting, and diarrhea.

These events occurred in 74.0% of participants receiving oral semaglutide compared with 42.2% in the placebo group. Most gastrointestinal events were mild to moderate in severity and decreased over time.

Treatment discontinuation due to adverse events occurred in 6.9% of participants receiving semaglutide, a rate broadly consistent with studies of injectable semaglutide.

UK Becomes First European Market for Wegovy Pill

Novo Nordisk described the approval as an important milestone for obesity care, providing patients with a non-injectable GLP-1 treatment option. Clinical experts noted that expanding access to effective therapies may help address the substantial health burden associated with obesity and related cardiometabolic conditions.

The UK approval follows earlier authorizations from the U.S. Food and Drug Administration and the United Arab Emirates’ Emirates Drug Establishment. Novo Nordisk has previously indicated plans to launch Wegovy pill in selected markets during the second half of 2026, positioning the therapy as a new oral treatment option in the rapidly expanding obesity market.

Reference

Novo Nordisk: Wegovy® pill (semaglutide tablets) becomes first daily GLP-1 weight-loss pill approved in the UK

First GLP-1 tablet for weight loss approved in the UK – GOV.UK