- FDA approved Wegovy\u00ae pill, an oral GLP-1, for weight management.
- OASIS 4 trial showed 16.6% mean weight loss with Wegovy\u00ae pill.
- Novo Nordisk plans US launch in early January 2026.
- Oral semaglutide 25 mg submitted to EMA in late 2025.
FDA Approval
The US FDA has approved the Wegovy® pill, a once-daily oral semaglutide 25 mg, for weight management. This marks the first oral GLP-1 receptor agonist therapy approved for this purpose.
Clinical Trial Results
The approval is based on results from the OASIS and SELECT trials. In the OASIS 4 trial, the Wegovy® pill demonstrated a mean weight loss of 16.6% in adults with obesity or overweight and comorbidities. One in three participants achieved a weight loss of 20% or more.
Safety and Tolerability
The safety and tolerability profile of the Wegovy® pill was consistent with previous semaglutide trials, reaffirming its known profile.
Launch Plans
Novo Nordisk plans to launch the Wegovy® pill in the US in early January 2026. The company has also submitted the oral semaglutide 25 mg for obesity to the European Medicines Agency and other regulatory bodies in the second half of 2025.
