Novo Nordisk announced earlier this year that it submitted an application for U.S. Food and Drug Administration (FDA) approval to sell oral Wegovy. With Eli Lilly preparing to apply for FDA approval for its oral anti-obesity drug, Orforglipron, the era of oral obesity medications appears to be officially arriving.
According to industry sources on Tuesday, Novo Nordisk applied to the FDA earlier this year seeking approval to market oral semaglutide (Wegovy) for overweight and obese patients in the United States. Detailed information, including the expected approval timeline, will be disclosed during the company’s earnings announcement on May 7.
A Novo Nordisk representative stated that the drug could potentially become the first FDA-approved GLP-1-based oral obesity treatment.
In 2023, Novo announced that its oral formulation of semaglutide demonstrated significant weight loss effects in a Phase 3 clinical trial. Participants who received the highest dose lost approximately 15% of their body weight over 64 weeks, a result comparable to that of the injectable formulation.
At that time, Novo did not immediately file for approval; instead, it focused on next-generation combination therapies and pipeline drugs such as CagriSema. However, the company appears to have revised its strategy this year amid intensifying competition in the obesity drug market.
Meanwhile, Novo’s competitor Eli Lilly recently reported positive results for its oral GLP-1 drug Orforglipron in a large-scale clinical trial involving diabetic patients. Based on these findings, Lilly plans to submit an FDA approval application within the year.