The logo of the pharmaceutical company Novo Nordisk is displayed in front of the company’s office in Bagsvaard, a suburb of Copenhagen, Denmark, on November 24, 2025.
Tom Little | Reuters
The U.S. Food and Drug Administration on Monday approved the first-ever GLP-1 pill to treat obesity, from the manufacturer Wegovy. novo nordiskMedical experts say the landmark decision could mean more patients can receive treatment.
Novo Nordisk said it plans to launch the pill in early 2026. The Danish drugmaker said a starting dose of 1.5 milligrams will be available from early January through pharmacies and some telemedicine providers for $149 a month.
Novo Nordisk did not say how much the higher-dose drug would cost, but said additional information about coverage and savings options for eligible patients would also be available at that time.
Novo Nordisk shares rose about 10% in after-hours trading.
The approval gives Novo Nordisk a head start against its biggest rival Eli Lilly, The company is currently the dominant player in the market and is rushing to launch its own obesity drug. Pills are the next battleground for the two drugmakers, establishing a fast-growing GLP-1 field that some analysts say could be worth about $100 billion by the 2030s.
Wall Street believes there is plenty of room for pills in the market, with Goldman Sachs analysts saying in August that they could capture a 24% share of the global weight-loss drug market in 2030, worth about $22 billion.
“What we’ve learned through years of research is that having an oral treatment option really opens up, activates and motivates different populations to seek treatment,” Dave Moore, Novo Nordisk’s executive vice president of U.S. operations, told CNBC ahead of the approval. “To talk to the doctor and see if this is right for the patient.”
“That’s what we’re excited about: giving people a choice and being able to make sure they have access and make it accessible like we’ve done with the shot,” he continued.
Novo Nordisk said the FDA’s approval also allows the pill to be used to reduce the risk of serious cardiovascular events such as death, heart attack, and stroke in adults with obesity or a history of cardiovascular disease. This is in line with the approved label for the company’s blockbuster weight loss drug Wegovy, which shares the same active ingredient semaglutide.
The approval was based on a Phase 3 study that followed more than 300 obese adults without diabetes.
The study showed that administration of 25 milligrams of Novo Nordisk’s oral semaglutide reduced patients’ weight by an average of up to 16.6% after 64 weeks, according to trial results presented at the 2024 Medical Congress. When the company analyzed all patients, regardless of whether they stopped taking the drug, weight loss was 13.6%.
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