Novo Nordisk has announced that the FDA has accepted the New Drug Application (NDA) for a once-daily 25 mg oral formulation of Wegovy (semaglutide) for chronic weight management in adults with obesity or overweight and related conditions, and to reduce cardiovascular risks in those with established heart disease. If approved in Q4 2025, this would be the first oral GLP-1 treatment for obesity.
The application is supported by the positive results of the OASIS 4 trial, a 64-week study in adults with obesity or overweight and comorbidities (excluding diabetes). The trial demonstrated the efficacy and safety of the 25 mg oral semaglutide compared to placebo, alongside lifestyle interventions.
Anna Windle of Novo Nordisk highlighted the significance of this development in offering patients more individualized treatment options, including an oral formulation. She emphasized the company’s long-standing commitment to obesity care and their anticipation of working with regulatory authorities to bring this potential first oral GLP-1 obesity treatment to patients.