Novo Nordisk B A/S (NVO,NOVOB.CO), a Denmark-based healthcare major, announced that the FDA has approved Wegovy pill, a once-daily 25 mg oral semaglutide, to reduce excess body weight, maintain long-term weight reduction, and reduce the risk of major adverse cardiovascular events.
Following the approval news, Novo Nordisk shares rose 10.12% to $52.97 in overnight trading.
The FDA approval was based on results from the OASIS trial program and the SELECT trial. In the OASIS 4 trial, oral semaglutide 25 mg once daily achieved a 16.6% mean weight loss in adult participants with obesity and one or more comorbidities. The Wegovy pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management. The company expects to launch the Wegovy pill in the US in early January 2026.
During the second half of 2025, the company submitted applications to the European Medicines Agency (EMA) and other regulatory authorities, seeking approval for once-daily oral semaglutide 25 mg for the treatment of obesity.
Wegovy, in its injectable formulation of semaglutide at a 2.4 mg dose, taken once weekly, has already received approval from the FDA, the European Medicines Agency (EMA), and several other regulatory authorities worldwide.
The weight loss achieved with the Wegovy pill was comparable to that of the 2.4 mg injectable Wegovy approved earlier. Furthermore, 1 in 3 participants achieved at least 20% weight loss in the OASIS 4 trial.
Earlier this November, Novo Nordisk submitted an sNDA to the U.S. Food and Drug Administration for a higher dose of semaglutide injection 7.2 mg for chronic weight management in adults with obesity.
In addition to weight management, Wegovy 2.4 mg injection is also indicated for cardiovascular risk reduction in people with obesity or overweight, and for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH).
According to Grandview Research, the global Wegovy (semaglutide) market was valued at $8,198.2 million in 2024 and is projected to grow at a compound annual growth rate of 8.8% from 2024 to 2035.
In the third quarter of 2025, Wegovy sales increased to 20.35 billion Danish Kroner from 17.30 billion Danish Kroner a year earlier.
NVO closed Monday's trading at $48.10, up 0.02%.
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