• The FDA has accepted Novo Nordisk's NDA for an oral formulation of Wegovy, potentially making it the first FDA-approved GLP-1 weight-loss pill.
• The application is based on Phase III OASIS 4 trial results, which showed significant weight loss in participants taking oral Wegovy compared to placebo.
• If approved, oral Wegovy will provide a new treatment option for chronic weight management in adults with obesity or overweight, offering an alternative to injectable GLP-1 medications.

The Food and Drug Administration (FDA) has accepted Novo Nordisk's New Drug Application (NDA) for an oral formulation of Wegovy (semaglutide) for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions. This acceptance marks a significant step towards potentially approving the first oral GLP-1 treatment for obesity. The application is based on the results of the phase 3 OASIS 4 trial, which evaluated the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo. The FDA is expected to make a decision on the application in the fourth quarter of 2025.

• What: The FDA accepted Novo Nordisk's New Drug Application (NDA) for an oral formulation of Wegovy (semaglutide) for chronic weight management.
• Who: Novo Nordisk, FDA, adults with obesity or overweight with at least one comorbidity, participants in the OASIS 4 trial, Eli Lilly.
• When: FDA acceptance occurred in May 2025, with a decision on approval expected in Q4 2025. OASIS 4 trial results were released in November 2024.
• Where: United States (FDA regulatory approval), clinical trial sites for OASIS 4.

The FDA's acceptance of Novo Nordisk's NDA for oral Wegovy marks a significant advancement in obesity treatment. The potential approval of the first oral GLP-1 medication for weight loss could greatly expand access and convenience for patients. The OASIS 4 trial results provide strong evidence for the efficacy of oral semaglutide. However, it's important to note that the drug can cause adverse effects like nausea, diarrhea, constipation, and abdominal pain, which patients should be aware of. The race between Novo Nordisk and Eli Lilly to bring the first weight-loss pill to market highlights the growing demand and investment in this area. Eli Lilly's orforglipron has also shown promising results, creating a competitive landscape that could benefit patients with more treatment options.

"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 anticipated FDA decision on Novo Nordisk's oral Wegovy in Q4 2025 marks a pivotal moment in obesity treatment, potentially introducing the first oral GLP-1 option for weight management, offering a convenient alternative to injectables. Phase III OASIS 4 study results demonstrated that oral Wegovy (25mg) could match the weight-lowering efficacy of weekly injectable Wegovy, significantly outperforming placebo with an average 13.6% weight reduction compared to 2.4% in the control group, while maintaining a similar safety profile. This advancement occurs amidst intense competition with Eli Lilly's orforglipron, another oral GLP-1 candidate, which has shown promising results in Phase 3 trials, including significant A1C reduction and nearly 8% weight loss over 40 weeks in individuals with obesity and type 2 diabetes. The availability of oral GLP-1 treatments is expected to expand access, improve patient adherence, and offer more individualized treatment plans, driving further innovation and providing diverse options for individuals managing obesity and related cardiovascular risks.