On Thursday, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) approved Novo Nordisk A/S’ (NYSE:NVO) Wegovy pill, clearing the company's first daily oral weight-management treatment for adults with obesity or overweight conditions linked to weight-related health issues.
The approval gives eligible patients a non-injectable alternative to GLP-1-based weight-loss therapies.
MHRA Clears First Oral Wegovy Option
According to Novo Nordisk, the newly approved Wegovy pill contains semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist.
The medicine is authorized for adults living with obesity, defined as a body mass index (BMI) of 30 kg/m² or higher, or for overweight adults with a BMI between 27 kg/m² and less than 30 kg/m² who have at least one weight-related condition.
The treatment is intended to be used alongside a reduced-calorie diet and increased physical activity.
Phase 3 Trial Showed Significant Weight Reduction
The MHRA's decision was supported by data from the Phase 3 OASIS 4 clinical trial, which evaluated semaglutide tablets in 307 adults with obesity or overweight and at least one weight-related condition, excluding patients with diabetes.
When treatment effects were assessed regardless of adherence, participants receiving semaglutide tablets 25 mg achieved approximately 13.6% weight loss after 64 weeks, compared with 2.4% for those receiving placebo, in addition to lifestyle interventions.
Among participants who adhered to treatment throughout the study, weight loss reached approximately 16.6% with semaglutide tablets, versus 2.7% with placebo after 64 weeks.
Safety Profile Consistent With Injectable Semaglutide
The most commonly reported adverse events were gastrointestinal, including nausea, vomiting, and diarrhea. These side effects were reported by 74.0% of participants in the oral semaglutide group and 42.2% of participants receiving placebo.
Novo Nordisk said the side effects were generally mild to moderate and temporary.
Treatment discontinuation due to adverse events occurred in about 6.9% of participants taking oral semaglutide, a rate the company said was consistent with findings from injectable semaglutide studies.
Commercial Launch Planned For 2026
Novo Nordisk previously announced plans to introduce the Wegovy pill in select markets during the second half of 2026.
The MHRA becomes the third regulatory authority to approve the medicine, following authorizations from the U.S. Food and Drug Administration and the United Arab Emirates' Emirates Drug Establishment.
Novo Nordisk announced Sunday that Wegovy (semaglutide) tablets 25 mg surpassed three million prescriptions in just over five months.
NVO Stock Price Activity: Novo Nordisk shares were up 1.20% at $43.32 at the time of publication on Thursday, according to Benzinga Pro data.
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