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 open up treatment access to more patients.

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

That’s the same price that cash-paying patients can access the starting dose of the pill on President Donald Trump’s direct-to-consumer website, TrumpRx, under a deal Novo Nordisk struck with his administration last month. Trump’s site also launches in January.

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 Monday.

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.

“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.

It’s unclear exactly how many people are using GLP-1s in the U.S., especially for obesity in particular. But around 1 in 8 adults said they were taking a GLP-1 drug to lose weight or treat another chronic condition as of November, according to a poll from health policy research organization KFF.

The move gives Novo Nordisk a head start over its 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.

In a note Monday, BMO Capital Markets analyst Evan Seigerman said the approval of Novo Nordisk’s pill gives the company a “much-needed win in light of recent challenges maintaining incretin market…