PLAINSBORO, N.J. — The U.S. Food and Drug Administration has approved Novo Nordisk’s Wegovy® pill, making it the first and only oral GLP-1 medication cleared for chronic weight management in adults, the company announced Monday.
The once-daily semaglutide 25 mg tablet is designed to be used alongside reduced-calorie diets and increased physical activity for adults with obesity or overweight with weight-related medical conditions. It also becomes the only GLP-1 treatment indicated to reduce the risk of major cardiovascular events—including death, heart attack, or stroke—in adults with overweight or obesity and established cardiovascular disease.
“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. “Now, with Wegovy pill, we’re offering a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in phase 3 trials.”
The FDA approval is supported by data from the OASIS 4 phase 3 clinical trial, which studied 307 adults with obesity or overweight without diabetes over 64 weeks. Results showed that patients taking Wegovy tablets lost an average of about 17% of their body weight if they remained on treatment, compared to about 3% with placebo. When factoring in all participants regardless of adherence, average weight loss was about 14% with Wegovy versus 2% with placebo.
Novo Nordisk said the Wegovy pill will launch nationwide in early January 2026 with a starting dose of 1.5 mg priced at $149 per month through savings offers. The medication is being manufactured in North Carolina with what the company described as a “robust supply” already on hand.
Since its initial approval as an injectable treatment in 2021, Wegovy has been prescribed to approximately 3.2 million people in the U.S., according to Novo Nordisk. The pill marks a major step in the company’s expansion of its GLP-1 portfolio, a class of drugs that has reshaped obesity and diabetes treatment worldwide.
The FDA’s approval of Novo Nordisk’s Wegovy pill introduces the first oral GLP-1 therapy for weight loss and cardiovascular protection in U.S. adults.