Novo Nordisk wins MHRA approval for oral Wegovy semaglutide pill
Novo Nordisk has secured approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for Wegovy pill, an oral formulation of semaglutide 25 mg taken once daily for weight management. The MHRA decision makes the UK the first European market to clear a daily GLP-1 receptor agonist tablet for obesity, and the third regulatory authority globally to do so after the US FDA and the United Arab Emirates.
The approval applies to adults living with obesity (BMI of 30 kg/m² or above) or overweight (BMI 27 to below 30 kg/m²) with at least one weight-related comorbidity. Novo Nordisk said private prescriptions are expected to be available within weeks, ahead of any anticipated NHS commissioning decision.
OASIS 4 trial data
The MHRA's decision rests on data from the OASIS 4 Phase 3 trial, a randomised, double-blind, placebo-controlled study of 307 adults without type 2 diabetes. In the treatment policy analysis, which captured outcomes regardless of adherence, participants receiving semaglutide tablets lost approximately 13.6% of body weight over 64 weeks compared with 2.4% in the placebo group. In the on-treatment analysis, reflecting results if all participants remained on therapy, weight loss reached 16.6% versus 2.7% for placebo.
Gastrointestinal side effects, including nausea, vomiting and diarrhoea, were reported by 74% of participants in the active arm compared with 42% in the placebo group. These events were described as generally mild to moderate in severity and transient. Treatment discontinuation due to adverse events occurred in approximately 7% of participants, a rate the company said is consistent with injectable semaglutide trial data.
Naveed Sattar, Professor of Cardiometabolic Medicine at the University of Glasgow, welcomed the decision: "Expanding the range of effective treatments is important in helping people sustainably reduce caloric intakes within an increasingly obesogenic environment."
Market and competitive context
The oral approval is strategically significant for Novo Nordisk, which faces intensifying competition in the injectable GLP-1 segment from Eli Lilly's tirzepatide (Mounjaro/Zepbound). An oral option removes a widely cited barrier to uptake: needle aversion. Novo Nordisk has indicated it plans broader rollout of Wegovy pill in select markets in the second half of 2026.
The oral GLP-1 space is attracting considerable pipeline interest beyond semaglutide. Several companies are developing oral small-molecule GLP-1 agonists and next-generation peptide formulations designed to improve bioavailability, which has historically been a challenge for oral peptide delivery. Semaglutide's oral form requires a specific absorption enhancer and strict fasting conditions, which the OASIS 4 protocol reflected through its lifestyle intervention component.
The UK obesity burden provides a sizeable addressable population: Novo Nordisk cites approximately 15 million people living with obesity in the UK, with projections suggesting 71% of adults will be living with obesity or overweight by 2040. NHS access at scale, however, will depend on NICE appraisal and commissioning decisions that have not yet been announced for the oral formulation. Investors will watch for any signals on NHS pathway timing as the key commercial inflection point in this market.
Emil Kongshøj Larsen, executive vice president of international operations at Novo Nordisk, described the approval as a landmark, noting that only a small proportion of the eligible UK population currently has access to treatment and expressing hope that the new option will broaden uptake.