Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for an oral version of Wegovy, the company’s widely used obesity treatment. The FDA is expected to make its decision on the drug by the end of this year.
This development brings the Danish pharmaceutical company closer to gaining approval for the first-ever oral GLP-1 pill specifically for weight loss. The oral Wegovy will feature a 25-mg dose and is intended for once-daily use by adults who are overweight or obese and have at least one additional health condition.
The FDA’s decision will be based on the results of the Phase III OASIS 4 study, which showed that daily oral Wegovy was just as effective as the injectable version in reducing body weight. A report from November 2024 indicated that the oral formulation could produce similar weight loss results to the weekly injection. While Novo did not release further details on the comparison between the oral and injectable versions in its latest update, OASIS 4 also demonstrated that oral Wegovy outperformed a placebo, leading to an average weight loss of 13.6% among participants, compared to only 2.4% in the placebo group. The safety profile of the oral version was similar to that of the injectable, with side effects such as nausea, diarrhea, constipation, and abdominal pain.
Last month, Novo confirmed its filing for approval of oral Wegovy. The company also pointed out that it already has an oral GLP-1 medication, Rybelsus, which was approved by the FDA in 2019. However, Rybelsus is used to treat type 2 diabetes, not for weight management.
Novo Nordisk is in competition with Eli Lilly to become the first company to launch an oral weight-loss pill. Eli Lilly recently revealed promising results for its oral GLP-1 treatment, orforglipron, which significantly lowered blood glucose levels in patients with type 2 diabetes. The drug also helped participants lose an average of 7.9% of their body weight, compared to 1.6% in the placebo group.
Lilly’s CEO, David Ricks, confirmed that while orforglipron’s current study focused on diabetes, the company plans to file for approval of the drug for chronic weight management later this year. A submission for type 2 diabetes approval is expected in 2026. Lilly has also committed to manufacturing the drug in the U.S.
