UK regulator approves the Wegovy pill for weight loss, a European first

Britain now has its first licensed GLP-1 tablet for weight loss, joining the United States and United Arab Emirates.

It is the first GLP-1 tablet approved for weight loss in the United Kingdom or elsewhere in Europe. The United States and United Arab Emirates approved it earlier.

The license covers adults with a body mass index of at least 30. Adults with a BMI from 27 through 29.9 also qualify with a weight-related health condition. The approval includes guidance on eating fewer calories and increasing physical activity.

Dosing starts at 1.5 mg once daily. It then increases through 4 mg, 9 mg, and 25 mg. Each level lasts at least one month before the next increase.

The MHRA says some private-care patients already taking 2.4 mg weekly semaglutide can move directly to the 25 mg daily tablet.

The tablet has strict timing rules because the gut absorbs semaglutide poorly. It must be swallowed whole after an eight-hour fast with a small amount of water. Food and other drinks must wait another 30 minutes. Breaking this routine reduces how much medicine enters the bloodstream.

The approval rests on OASIS 4, a 64-week study of 307 adults at 22 sites in four countries. Participants were assigned by chance, two-to-one, to the 25 mg tablet or a placebo. Neither participants nor researchers knew the assignment during the study.

Average weight loss was 13.6% with semaglutide and 2.4% with placebo in the main analysis. Among people who stayed on treatment as planned, the figures were 16.6% and 2.7%. Serious adverse events occurred in 3.9% of the semaglutide group and 8.8% of the placebo group.

The MHRA lists nausea, diarrhoea, constipation, and vomiting among common side effects. Patients can report suspected side effects through its Yellow Card scheme.

The tablet is not available on the NHS. NICE will run its normal appraisal before that can happen.

The tablet offers another route with strict timing

The tablet gives eligible adults another way to take semaglutide. It does not require an injection, but it adds a strict daily routine.

In the UK, the tablet is available only by private prescription while NICE reviews NHS coverage. It requires an overnight fast and a 30-minute wait before food or other drinks. That routine differs from a once-weekly injection.

OASIS 4 did not compare the pill with injections

OASIS 4 compared the tablet with placebo, not with injectable semaglutide or tirzepatide. Results from separate trials do not prove which product works better.

The 307-person trial was not designed to measure cardiovascular outcomes. Its 64-week follow-up also does not show results over five or ten years. The tablet carries the same GLP-1 class warnings as the injection, so it is not a gentler form of semaglutide.

Approval does not guarantee NHS funding, a fixed price, or local pharmacy stock. NICE has not issued guidance. The approval also does not make unapproved oral semaglutide from outside licensed pharmacies safe or legitimate.