FDA approves first GLP-1 pill for obesity from Wegovy maker Novo Nordisk

The U.S. Food and Drug Administration on Monday approved the first-ever GLP-1 pill for obesity from Wegovy maker Novo Nordisk, a landmark decision that health experts say could potentially open up treatment access to more patients.

Novo Nordisk said it expects to launch the pill in early 2026. The Danish drugmaker said the starting dose of 1.5 milligrams will be available starting in early January in pharmacies and via select telehealth providers for $149 per month.

Novo Nordisk did not say how much higher doses of the drug would cost, but said additional information on coverage and savings options for eligible patients will be available at that time as well.

Shares of Novo Nordisk gained roughly 10% in extended trading.

The approval gives Novo Nordisk a head start over chief rival Eli Lilly, which is currently the dominant player in the market and is racing to launch its own obesity pill. Pills are the next battleground for the two drugmakers, which established the booming GLP-1 space that some analysts say could be worth roughly $100 billion by the 2030s.

Wall Street thinks there’s plenty of room for pills in the market, with Goldman Sachs analyst saying in August that pills could capture a 24% share — or around $22 billion — of the 2030 global weight loss drug market.

“What we’ve learned through years of research is that having an oral option really kind of 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. “To 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 — to be able to give people an option and make sure we have access and ease of access like we have been doing with our injections,” he continued.

The FDA’s approval also clears the pill for 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. That’s consistent with the approval label of the company’s blockbuster 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 results from the trial presented at a medical conference in 2024. That weight loss was 13.6% when the company analyzed all patients regardless of whether they stopped the drug.

The pill appears to be slightly more effective than an experimental oral drug from Eli Lilly, which is still waiting for FDA approval.

But unlike Novo Nordisk’s pill, Eli Lilly’s treatment is not a peptide medication. That means it is absorbed more easily by the body and does not require dietary restrictions. People who take Novo Nordisk’s pill have to wait 30 minutes before eating or drinking each day.

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