US FDA approves Novo Nordisk's Wegovy® pill, first and only oral GLP-1 for weight loss in adults

December 23, 2025 | Tuesday | News

Novo Nordisk expects to launch Wegovy® pill in early January 2026

image credit- freepik

image credit- freepik

Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved once-daily Wegovy® pill, the first oral GLP-1 medicine for obesity in the US. 

Wegovy® pill is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. Wegovy® pill is also indicated to reduce the risk of major adverse cardiovascular events (MACE) such as 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 US. Now, 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. We are confident that the expansion of Wegovy® to a pill will help patients who may have not sought or accepted treatment before," said Dave Moore, Executive Vice President, US Operations at Novo Nordisk. "Wegovy® pill is the next chapter in our decades-long GLP-1 experience—supported by the most affordable self-pay price to date in a GLP-1 for obesity. We are prepared for a full US launch in early January 2026, with manufacturing well underway in our North Carolina facilities."

 

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