Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved the Wegovy® pill, a once-daily oral semaglutide 25 mg, to reduce excess body weight, support long-term weight maintenance, and lower the risk of major adverse cardiovascular events.
First Oral GLP-1 Therapy for Weight Management
With this approval, the Wegovy® pill becomes the first oral glucagon-like peptide-1 (GLP-1) receptor agonist indicated for weight management. The FDA decision is based on robust evidence from the OASIS clinical trial programme and the SELECT trial.
In particular, the OASIS 4 trial demonstrated that once-daily oral semaglutide 25 mg achieved a mean weight loss of 16.6% in adults with obesity or overweight and at least one comorbidity, when patients adhered to treatment. Importantly, the weight loss observed with the Wegovy® pill matched the outcomes seen with injectable Wegovy® 2.4 mg. Moreover, one in three participants achieved 20% or greater weight loss during the study. The trial also reaffirmed the well-established safety and tolerability profile of semaglutide.
Leadership Highlights Patient Convenience and Impact
Commenting on the approval, Mike Doustdar, President and CEO of Novo Nordisk, said the once-daily pill offers patients a convenient alternative to injections without compromising efficacy. He noted that, as the first oral GLP-1 therapy for people living with overweight or obesity, the Wegovy® pill provides a new and accessible option to help patients begin or continue their weight-loss journey. He also emphasised that no other oral GLP-1 therapy currently matches the level of weight loss achieved with the Wegovy® pill.
Launch Timeline and Global Regulatory Plans
As per the press release, Novo Nordisk plans to launch the Wegovy® pill in the United States in early January 2026. Meanwhile, the company has submitted oral semaglutide 25 mg for obesity to the European Medicines Agency (EMA) and other regulatory authorities during the second half of 2025.
About the OASIS Programme and Wegovy®
The OASIS phase 3 clinical programme evaluated once-daily oral semaglutide 25 mg and 50 mg across four global trials involving approximately 1,300 adults with obesity or overweight and related comorbidities. Wegovy® is currently available as a once-weekly injection and, following FDA approval, as a once-daily pill, further expanding treatment options for chronic weight management and cardiovascular risk reduction.