FDA Approves Novo Nordisk’s Once-Daily Wegovy® Pill, The First Oral GLP-1 For Weight Management With Injectable-Level Results

Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has approved the once-daily Wegovy® pill (oral semaglutide 25 mg). This new oral treatment is approved for reducing excess body weight, helping patients maintain long-term weight loss, and lowering the risk of major adverse cardiovascular events. The Wegovy pill is the first oral GLP-1 (glucagon-like peptide-1) receptor agonist approved specifically for weight management, marking an important milestone in obesity treatment.

The FDA approval is supported by results from the OASIS clinical trial program and the large SELECT cardiovascular outcomes trial. In the OASIS 4 study, adults with obesity or overweight and at least one weight-related health condition achieved an average 16.6% weight loss when they consistently took oral semaglutide 25 mg once daily. This level of weight reduction is comparable to the results seen with injectable Wegovy 2.4 mg. Additionally, one in three trial participants achieved 20% or more weight loss, showing the strong effectiveness of the treatment. The safety and tolerability profile of the Wegovy pill in the OASIS 4 trial was consistent with findings from previous semaglutide studies used for weight management.

Mike Doustdar, President and CEO of Novo Nordisk, said that the approval brings a significant convenience advantage for patients. He explained that the Wegovy pill offers the same level of weight loss as the injectable version but in an easy, once-daily oral form. He highlighted that this is the first oral GLP-1 option available for people living with overweight or obesity, giving patients more flexibility and potentially encouraging more individuals to begin or continue their weight-loss efforts.

Novo Nordisk plans to introduce the Wegovy pill in the U.S. in early January 2026. The company has also submitted the once-daily 25 mg oral semaglutide for regulatory review to the European Medicines Agency (EMA) and other global health authorities during the second half of 2025.