• The FDA accepted Novo Nordisk's NDA for oral semaglutide 25 mg for chronic weight management.
• If approved, it would be the first oral GLP-1 treatment option for obesity.
• The FDA decision date is expected in Q4 2025.

The U.S. Food and Drug Administration (FDA) has accepted Novo Nordisk's New Drug Application (NDA) for an investigational once-daily, 25 mg oral formulation of Wegovy® (semaglutide) for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions and to reduce the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease. This acceptance marks a significant step towards potentially providing the first oral GLP-1 treatment option for obesity, offering patients more choices in their treatment plans. The decision by the FDA is anticipated in Q4 2025.

• What: FDA accepted the New Drug Application (NDA) for oral semaglutide 25 mg for chronic weight management.
• Who: Novo Nordisk, FDA, adults with obesity or overweight.
• When: Application accepted in May 2025, FDA decision expected in Q4 2025. The OASIS 4 trial was 64 weeks.
• Where: United States.

The FDA's acceptance of the NDA for oral semaglutide 25 mg represents a significant advancement in obesity treatment. Currently, GLP-1 receptor agonists are primarily available as injectable medications. An oral formulation would offer a more convenient and potentially more accessible option for many patients. The OASIS 4 trial results support the efficacy and safety of the oral semaglutide, excluding patients with diabetes. The outcome of the FDA review in Q4 2025 will be closely watched by the medical community and patients alike, as it could reshape the landscape of obesity management.

"We are entering a new era of obesity care where patients want individualized treatment plans that address their needs and provide choices, including oral formulations."

The FDA's acceptance of the NDA for oral semaglutide 25 mg is a promising development in obesity treatment, potentially offering the first oral GLP-1 option. The FDA is expected to make a decision in Q4 2025. If approved, this new formulation could provide a more convenient alternative for patients and expand access to effective weight management therapies. This action is a reflection of the evolving landscape of obesity care, with a focus on personalized treatment approaches.