FDA Approves Novo Nordisk's Wegovy Pill, First Oral GLP-1 Therapy For Weight Management

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(RTTNews) - Novo Nordisk (NVO, NOVOB.CO) announced that the US Food and Drug Administration approved the Wegovy pill (once-daily oral semaglutide 25 mg) to reduce excess body weight and maintain weight reduction long term and to reduce the risk of major adverse cardiovascular events. The Wegovy pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management.

The company expects to launch the Wegovy pill in the US in early January 2026. The company 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.

Wegovy is now approved as once-daily Wegovy pill (semaglutide tablet 25 mg) and once-weekly Wegovy injection (semaglutide injectable 2.4 mg) by the FDA.

Wegovy is approved as a once-weekly injection by the EMA and widely by other regulatory authorities. The Wegovy pill is currently pending marketing approval from the EMA and 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.

Furthermore, Wegovy injection is indicated to reduce excess body weight and maintain weight reduction long term in paediatric patients aged 12 years and older, and approved by the FDA for the treatment of MASH in adults with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.

NVO closed Monday's regular trading at $48.10, a slight increase of $0.01 or 0.02%. In overnight trading, the stock surged to $53.01, marking a gain of $4.91 or 10.21%.

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