Novo Nordisk gets USFDA nod for weight loss drug Wegovy as once a day pill

Danish drug major Novo Nordisk has received US Food and Drug Administration (FDA) approval to sell its blockbuster weight loss drug Wegovy (semaglutide 25 mg) as once a day oral pill  in that country.

Wegovy pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management in the US, the company said.

Novo Nordisk’s OASIS clinical trial programme had shown that Wegovy pill will reduce excess body weight and maintain weight reduction long term and reduce the risk of major adverse cardiovascular events. The well-known safety and tolerability profile of semaglutide was reaffirmed with the Wegovy pill in the clinical trials which was comparable to previous trials with semaglutide for weight management, the company said in a statement.

“The pill is here. With today's approval of the Wegovy pill, patients will have a convenient, once- daily pill that can help them lose as much weight as the original Wegovy® injection,” said Mike Doustdar, president and CEO of Novo Nordisk. “As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey. No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy pill, and we are very excited for what this will mean for patients in the US”.

Novo Nordisk expects to launch the Wegovy pill in the US in early January 2026. Novo Nordisk has submitted oral semaglutide 25 mg once-daily for obesity to the European Medicines Agency (EMA) and other regulatory authorities during the second half of 2025.

OASIS was a phase 3 clinical development programme with once-daily oral semaglutide 25 mg and 50 mg in obesity. The global clinical phase 3 programme consisted of four trials, enrolling approximately 1,300 adults with obesity or overweight with one or more comorbidities.

Wegovy is approved as a once-weekly injection by the EMA and widely by other regulatory authorities.

Wegovy is indicated to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight and in the presence of at least one weight-related comorbid condition, and approved by the FDA to reduce the risk of major adverse cardiovascular events, such as death, heart attack or stroke in adults with known heart disease and either obesity or overweight.