Novo Nordisk Gains MHRA Approval for Wegovy Pill, First Oral GLP-1 Weight-Loss Tablet in UK

Scaling oral semaglutide to meet private prescription demand will test Novo Nordisk's manufacturing readiness within weeks of the MHRA granting approval for Wegovy pill (semaglutide tablets 25 mg), the first oral GLP-1 receptor agonist licensed for weight management in the UK and the first such approval anywhere in Europe.

The authorisation is grounded in OASIS 4, a phase 3 trial enrolling 307 adults with obesity or overweight and at least one weight-related condition, without diabetes. Participants receiving semaglutide 25 mg achieved 13.6% mean weight loss versus 2.4% with placebo at 64 weeks under an intent-to-treat analysis; per-protocol adherence data showed 16.6% versus 2.7%. Gastrointestinal adverse events, nausea, vomiting, diarrhoea, were reported in 74.0% of the active arm compared with 42.2% in the placebo arm, characterised as generally mild to moderate and transient. Discontinuation due to adverse events reached 6.9%, consistent with injectable semaglutide trial data.

The licensed indication covers adults with a BMI of 30 kg/m² or above, or 27 kg/m² to below 30 kg/m² with at least one weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity. That population framing carries direct implications for prescribing infrastructure: with approximately 15 million people in the UK classified as living with obesity, demand forecasting and supply-chain planning will be central operational priorities ahead of the anticipated private prescription launch.

For QA and supply-chain leads, the oral dosage form introduces a distinct manufacturing profile relative to the prefilled injectable presentations already on market. Tablet production at commercial scale requires validated processes aligned with 21 CFR Part 211 equivalents under UK GMP, with particular attention to dissolution consistency and stability data supporting the 25 mg dose across the distribution chain. Novo Nordisk has not disclosed the manufacturing site or batch release strategy for the UK market at this stage.

The MHRA decision positions the UK ahead of other European markets and adds a second approved Wegovy presentation to the UK formulary alongside the subcutaneous injection, broadening the treatment pathway for clinicians managing long-term obesity care.

The private prescription availability timeline, described by Novo Nordisk as within weeks, will serve as the first measurable indicator of whether the company's supply network can absorb initial demand without the allocation constraints that have affected injectable GLP-1 products in comparable launch windows.

Source: Novo Nordisk via GlobeNewswire, 11 June 2026.