The FDA approves the first GLP-1 anti-obesity pill from Wegovy maker Novo Nordisk

The logo of pharmaceutical company Novo Nordisk is seen outside its offices in Bagsvaerd, on the outskirts of Copenhagen, Denmark, on November 24, 2025.

Tom Little | Reuters

The U.S. Food and Drug Administration on Monday approved the first GLP-1 anti-obesity pill from manufacturer Wegovy Novo Nordiska groundbreaking decision that health experts say could give more patients access to treatment.

Novo Nordisk expects to bring the pill to market in early 2026. The Danish drugmaker said the initial 1.5 milligram dose will be available in pharmacies and through select telemedicine providers with savings offers for $149 per month starting in early January.

That’s the same price at which cash-paying patients can access initial doses of the pill on President Donald Trump’s direct-to-consumer website, TrumpRx, under an agreement Novo Nordisk struck with his administration last month. Trump’s website will also launch in January.

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

Shares of Novo Nordisk rose about 10% in extended trading on Monday.

The FDA approval also gives the pill permission to reduce the risk of serious cardiovascular events such as death, heart attack or stroke in adults with obesity and existing cardiovascular disease, according to Novo Nordisk.

This is in line with the approval of the company’s blockbuster weight loss drug Wegovy, which contains the same active ingredient semaglutide. Both work by mimicking the gut hormone GLP-1 to suppress appetite.

“What we’ve learned through years of research is that an oral option really opens up, activates and motivates different segments to seek treatment,” Dave Moore, executive vice president of U.S. operations at Novo Nordisk, told CNBC before the approval. “Having that conversation with her doctor to see if this is something that might be right for her.”

“That’s what we’re excited about – giving people an option and making sure we have access and easy access like we did with our injections,” he continued. He added that since the pill contains the same active ingredient as Wegovy, patients will enjoy “comfort and familiarity” in terms of safety and effectiveness.

Some health experts said the pills could reach people who are afraid of needles or patients who could benefit from existing shots but don’t take them because they don’t consider their need serious enough.

It’s unclear exactly how many people in the United States use GLP-1, particularly for obesity. However, in November, about one in eight adults said they were taking a GLP-1 drug for weight loss or to treat another chronic condition, according to a survey by health research organization KFF.

The approval gives Novo Nordisk a leg up on its main competitor Eli Lilly, The company is currently the dominant player in the market and is trying to launch its own obesity pill. Pills are the next battleground for the two drugmakers that founded the booming GLP-1 market, which some analysts believe could be worth around $100 billion by the 2030s.

Wall Street believes there is plenty of room for pills in the market. 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.

In a note Monday, BMO Capital Markets analyst Evan Seigerman said Novo Nordisk’s pill approval gave the company a “much-needed victory given recent challenges in maintaining incretin market share dominance.”

Incretins refer to treatments that mimic gut hormones such as GLP-1. Eli Lilly captured the largest market share earlier this year thanks to its blockbuster obesity injection Zepbound, which has proven more effective than Novo Nordisk’s Wegovy.

“Novo will likely benefit from first-mover advantage and attract patients who have a preference for the convenience and convenience of oral dosing,” Seigerman said. However, he also noted that the market is “evolving rapidly as competitive assets are in development” and that approval of Eli Lilly’s pill, orforglipron, is “imminent.”

What you should know about the Wegovy pill

The approval is based on a Phase III study that followed more than 300 adults with obesity but not diabetes.

In this 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 study results presented at a 2024 medical conference. This weight loss was 13.6% when the company analyzed all patients, regardless of whether they stopped the medication.

The pill appears to be slightly more effective than an experimental oral drug from Eli Lilly that is still awaiting FDA approval.

But unlike Novo Nordisk’s pill, Eli Lilly’s treatment is not a peptide drug. This means it is more easily absorbed by the body and no dietary restrictions are required. People taking the Novo Nordisk pill must wait 30 minutes each day before eating or drinking.

But Moore said several existing medications have the same nutritional requirements, so “we don’t see it as something that affects treatment adherence.” He noted that Novo Nordisk’s research has found that remembering to take their medications with a few sips of water in the morning helps patients remember.

“It’s actually a compounding factor for patients,” Moore said.

He added that the pill’s prices are moving closer to what some people pay for unapproved, compounded versions of brand-name GLP-1, some of which are still illegally mass-marketed and sold in the United States

Patients flocked to the cheaper copycat products when Ozempic and Wegovy were in short supply over the past two years due to soaring demand or when they lacked insurance coverage for the costly treatments. When shortages are identified by the FDA, pharmacists can legally make compounded versions of brand-name drugs. But the agency noted earlier this year that the shortage of semaglutide, which bans the practice in many cases, is over.

“It continues to be alarming and concerning to us,” Moore told CNBC, referring to illegal ingredients illegally imported into the U.S. and used by some pharmacies to make copycat versions of brand-name GLP-1.

Regarding manufacturing, Moore said the company is “poised to be able to meet a lot of demand here in the U.S. and we’re pretty excited about it.” Novo Nordisk said production is underway at its North Carolina facilities.