• The FDA has accepted Novo Nordisk's NDA for oral Wegovy, with a decision expected in Q4 2025, potentially marking the first oral GLP-1 treatment for obesity.
• Clinical trials (OASIS 4) showed that oral Wegovy resulted in an average weight loss of 13.6% compared to 2.4% with a placebo, with a safety profile similar to the injectable form.
• Novo Nordisk is in competition with Eli Lilly, which is also developing an oral GLP-1 treatment (orforglipron) for weight management, with both companies aiming for regulatory approval in the near future.

Novo Nordisk is making significant strides in the field of obesity treatment with its oral formulation of Wegovy. The FDA's acceptance of the New Drug Application brings the company closer to launching the first oral GLP-1 medication specifically for chronic weight management. This development has the potential to revolutionize obesity care by offering patients a more convenient and accessible treatment option. Clinical trial data, specifically the OASIS 4 study, supports the efficacy of oral Wegovy, showing substantial weight loss compared to placebo. This progress positions Novo Nordisk as a leader in the competitive landscape of obesity treatments, alongside companies like Eli Lilly who are also developing similar medications.

• What: The FDA 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 with obesity or overweight and to reduce the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease.
• Who: Novo Nordisk is the developer. The FDA is the regulatory agency. Adult patients with obesity or overweight with one or more comorbid conditions are the target population. Anna Windle, PhD, Senior Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk Inc.
• When: FDA acceptance occurred in May 2025. The FDA action date for a decision is expected in Q4 2025. OASIS 4 study results were released in November 2024.
• Where: The drug will be available in the U.S. if approved. Clinical trials (OASIS 4) were conducted on a group of participants.

The FDA's acceptance of Novo Nordisk's NDA for oral Wegovy represents a significant advancement in obesity treatment. An oral GLP-1 medication offers a less invasive and potentially more convenient alternative to injectable options. The OASIS 4 study results demonstrate the efficacy of oral Wegovy in promoting weight loss. The competition with Eli Lilly's orforglipron suggests a growing market for oral weight-loss drugs, potentially leading to more accessible and diverse treatment options for individuals struggling with obesity. The claim to reduce MACE in obese or overweight individuals with established cardiovascular disease is another significant aspect of the drug's potential impact.

"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."

Novo Nordisk's oral Wegovy is poised to potentially become the first FDA-approved oral GLP-1 treatment for obesity, with a decision expected in Q4 2025, marking a significant advancement in weight management options. The FDA has accepted Novo Nordisk's New Drug Application for oral Wegovy. If approved, the 25-mg oral formulation, taken once-daily, would be indicated for adults with obesity or overweight with at least one comorbidity. Clinical trials, such as the Phase III OASIS 4 study, have demonstrated that oral Wegovy can match the weight-lowering effects of weekly injectable Wegovy, resulting in an average 13.6% weight reduction compared to 2.4% with placebo, while maintaining a similar safety profile. While Rybelsus is an existing oral GLP-1 from Novo Nordisk, it is approved for type 2 diabetes, not chronic weight management. However, oral Wegovy faces competition from Eli Lilly, which is developing orforglipron, another oral GLP-1 agonist. Lilly plans to submit orforglipron for weight management to global regulatory agencies by the end of 2025, with a submission for type 2 diabetes anticipated in 2026. Phase 3 trial results for orforglipron in adults with type 2 diabetes showed promising weight loss of nearly 8% after 40 weeks. Clinical trials data also indicates a reduction in A1C levels by 1.3% to 1.6% across different doses, and participants taking the highest dose also lost an average of 16 pounds. The most common adverse effects were mild to moderate gastrointestinal issues. The future of oral GLP-1 medications appears promising, with several companies, including Pfizer, developing their own formulations. These drugs have the potential to expand beyond diabetes and obesity, with emerging opinions suggesting they may have potential in treating non-alcoholic fatty liver disease and polycystic ovary syndrome. These oral options aim to provide a convenient, needle-free alternative to injectable GLP-1s, potentially improving patient adherence and expanding market reach. Analysts project multiple GLP-1 launches annually, starting in 2026, with the first oral entrant expected by 2027.