The logo of pharmaceutical company Novo Nordisk is displayed in front of its offices in Bagsvaerd, outside Copenhagen, Denmark, on November 24, 2025.
Little Tom | Reuters
The US Food and Drug Administration on Monday approved the first GLP-1 obesity pill from manufacturer Wegovy. Nordiska landmark decision that health experts say could potentially open access to treatment to more patients.
Novo Nordisk said it hopes to launch the pill in early 2026. The Danish drugmaker said the 1.5-milligram starting dose will be available starting in early January in pharmacies and through select telehealth providers for $149 a month.
Novo Nordisk did not say how much the higher doses of the drug would cost, but said additional information on coverage and savings options for eligible patients will also be available at that time.
Novo Nordisk shares gained about 10% in extended trading.
Approval gives Novo Nordisk an advantage over its main rival Eli Lilly, which is currently the dominant player in the market and is vying to launch its own anti-obesity pill. Pills are the next battleground for the two drugmakers, which have established the burgeoning GLP-1 space that some analysts say could be worth roughly $100 billion by the 2030s.
Wall Street believes there is plenty of room for pills in the market, and a Goldman Sachs analyst said in August that pills could capture a 24% share (or about $22 billion) of the global weight-loss drug market by 2030.
“What we've learned through years of research is that having an oral option really opens up, activates and motivates different segments to seek treatment,” Dave Moore, Novo Nordisk's executive vice president of U.S. operations, told CNBC ahead of the approval. “Have that conversation with their doctor to see if this is something that might be right for them.”
“That's what we're excited about: being able to give people a choice and make sure we have access and ease of access like we've been doing with our shots,” he continued.
The FDA approval also authorizes the pill's use to reduce the risk of major cardiovascular events, such as death, heart attack or stroke, in adults with obesity and established cardiovascular disease, according to Novo Nordisk. This is consistent with the approval label for the company's hit weight-loss drug Wegovy, which shares the same active ingredient, semaglutide.
The approval is based on a phase three trial that followed more than 300 adults with obesity but not diabetes.
In that study, a 25-milligram dose of Novo Nordisk's oral semaglutide helped patients lose up to 16.6% of their weight on average after 64 weeks, according to trial results presented at a medical conference in 2024. That weight loss was 13.6% when the company looked at all patients regardless of whether they stopped the drug.
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