Novo Nordisk’s Wegovy pill (semaglutide tablets 25 mg) has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for weight management in adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m² to <30 kg/m²) with at least one weight-related condition, as an adjunct to a reduced-calorie diet and increased physical activity. The approval makes the UK the first country in Europe to authorize the oral formulation and marks a meaningful shift in the delivery options available within the GLP-1 receptor agonist class, which has until now relied exclusively on injectable administration for obesity indications.
The MHRA authorization covers once-daily oral dosing, positioning Wegovy pill as an alternative to weekly subcutaneous injection for eligible adults. Novo Nordisk (Copenhagen: NOVO B) indicated the product will be available via private prescription within weeks. The MHRA is the third regulatory authority globally to license the medicine, following the US FDA and the UAE’s Emirates Drug Establishment.
Semaglutide is a GLP-1 receptor agonist that reduces appetite and caloric intake through central and peripheral receptor activation. The oral formulation uses Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC) as an absorption enhancer to enable gastric uptake of the peptide — a delivery challenge that has historically limited oral bioavailability of this drug class. Novo Nordisk acquired full ownership of the SNAC technology through its USD 1.8 billion purchase of Emisphere Technologies in 2020.
The approval is supported by data from OASIS 4, a randomized, double-blind, placebo-controlled Phase III trial enrolling 307 adults with obesity or overweight and at least one weight-related comorbidity, without type 2 diabetes. The trial’s co-primary endpoints were percentage change in body weight and the proportion of participants achieving ≥5% weight loss at week 64. In the treatment policy analysis — reflecting outcomes regardless of discontinuation — participants receiving semaglutide 25 mg achieved 13.6% mean weight loss versus 2.4% with placebo. The on-treatment analysis, assuming full adherence, reported 16.6% versus 2.7% weight loss. Gastrointestinal adverse events were reported in 74% of the semaglutide group, broadly consistent with rates observed in injectable semaglutide trials.