WASHINGTON — The Food and Drug Administration has approved a once-daily oral version of Wegovy, making Novo Nordisk’s semaglutide tablet the first and only oral GLP-1 therapy authorized in the U.S. for chronic weight management in adults. The approval broadens the Wegovy portfolio beyond injections and offers a new administration option for patients with obesity or overweight and at least one weight-related comorbidity.
The Wegovy pill is approved for use with a reduced-calorie diet and increased physical activity to help adults lose weight and keep it off. It also is indicated to lower the risk of major adverse cardiovascular events, including heart attack and stroke, in adults with established cardiovascular disease and overweight or obesity, a point Novo Nordisk emphasized as demand for GLP-1 therapies keeps rising.
FDA approval was based on results from the phase 3 OASIS 4 trial, a 64-week, randomized, double-blind study involving 307 adults with obesity or overweight and at least one weight-related condition, excluding diabetes. Trial results showed that patients taking the Wegovy pill achieved an average weight loss of about 17% if all patients stayed on treatment, compared to around 3% for the placebo. When analyzed regardless of treatment discontinuation, average weight loss was about 14% versus roughly 2% for the placebo.
Novo Nordisk stated that safety results aligned with previous Wegovy studies, with the most common adverse events being nausea, diarrhea, and vomiting. The company also highlighted that these findings reinforce semaglutide’s proven effectiveness while providing a non-injectable option that might appeal to patients hesitant to begin injectable therapy.
“The launch of Wegovy in 2021 changed how obesity was viewed and treated in the U.S.,” said Dave Moore, executive vice president of U.S. Operations at Novo Nordisk. “With Wegovy pill, we are offering a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in phase 3 trials.”
Novo Nordisk plans to launch fully in the U.S. in early January 2026. A 1.5-mg starting dose will be available at the same time for $149 per month through savings offers, according to the company. Manufacturing is ongoing at U.S. facilities, and Novo Nordisk stated that supply is strong ahead of the launch.
The approval comes as pharmacies, payers and manufacturers continue to navigate strong consumer demand for GLP-1 therapies and growing interest in oral alternatives that could broaden access and adherence. Novo Nordisk said Wegovy has been prescribed to approximately 3.2 million people in the U.S. to date, underscoring the category’s rapid growth as new formulations reach the market.
