BAGSVAERD, Denmark – January 2026 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Wegovy® pill (once-daily oral semaglutide 25 mg). This milestone marks the first time an oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy has been approved for chronic weight management.
The Wegovy® pill is indicated to reduce excess body weight and maintain long-term weight reduction in adults with obesity or overweight with at least one weight-related comorbidity. Furthermore, it is approved to reduce the risk of major adverse cardiovascular events (MACE).
Clinical Excellence: The OASIS 4 and SELECT Trials
The FDA approval is underpinned by the comprehensive OASIS clinical trial programme and the SELECT trial. Key findings from the OASIS 4 trial include:
- Significant Weight Loss: Adult participants achieved a 16.6% mean weight loss when treatment was adhered to.
- Superior Results: One in three participants experienced a 20% or greater reduction in body weight.
- Injectable Comparability: The weight loss delivered by the 25 mg oral pill is comparable to the results seen with the injectable Wegovy® 2.4 mg.
- Proven Safety: The safety and tolerability profile remains consistent with previous semaglutide trials, ensuring a well-understood experience for patients and providers.
A New Era of Convenience
“The pill is here. With today’s approval of the Wegovy® pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy® injection,” said Mike Doustdar, President and CEO of Novo Nordisk.
“As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy® pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey. No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy® pill, and we are very excited for what this will mean for patients in the US.”
Availability and Global Expansion
Novo Nordisk expects to launch the Wegovy® pill in the United States in early January 2026.
In addition to the US approval, Novo Nordisk submitted oral semaglutide 25 mg for obesity to the European Medicines Agency (EMA) and other global regulatory authorities during the second half of 2025, continuing its commitment to expanding access to innovative metabolic healthcare globally.
About Wegovy® (semaglutide 25 mg) pill
The Wegovy® pill is a once-daily oral medication. It mimics the GLP-1 hormone that targets areas of the brain that regulate appetite and food intake. In addition to weight management, it is the only oral GLP-1 therapy proven to reduce the risk of major cardiovascular events in specific populations.
