• The FDA has accepted Novo Nordisk's application for an oral version of Wegovy (semaglutide) for chronic weight management.
• The application is based on the OASIS 4 trial, demonstrating the efficacy and safety of a 25mg oral dose.
• Approval would make Wegovy the first oral GLP-1 treatment for obesity, potentially expanding its market reach, though Eli Lilly is developing a competitor.

The U.S. Food and Drug Administration (FDA) has accepted Novo Nordisk's New Drug Application (NDA) for a 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 application is based on the Phase 3 OASIS 4 trial, which showed positive results. If approved, Wegovy would become the first oral GLP-1 treatment for obesity, representing a significant advancement in weight management options.

• What: The FDA has accepted Novo Nordisk's application for an oral formulation of Wegovy for chronic weight management.
• Who: Novo Nordisk, FDA, adults with obesity or overweight, Eli Lilly (competitor).
• When: FDA acceptance announced May 2, 2025. FDA decision expected in Q4 2025. OASIS 4 trial was 64 weeks.
• Where: United States.

The FDA's acceptance of Novo Nordisk's oral Wegovy application marks a significant step forward in obesity treatment. The potential approval of the first oral GLP-1 treatment could greatly expand access and patient preference. The OASIS 4 trial results support the efficacy of the oral formulation. While this is a positive development for Novo Nordisk, competition from Eli Lilly's developing weight loss pill remains a factor. The stock market reaction indicates investor optimism, although the recent decline in NVO stock suggests existing market pressures.

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 Novo Nordisk's oral Wegovy application is a promising development in obesity treatment. If approved, it would offer a convenient alternative to injectable GLP-1 medications. The FDA's decision is expected in Q4 2025. The market potential is significant, but Novo Nordisk faces competition from Eli Lilly. The company's strong legacy and scientific research position it well in the evolving obesity care landscape.