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. Both work by mimicking the gut hormone GLP-1 to suppress appetite.

“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. He added that patients will have the “comfort and familiarity” on the safety and efficacy side since the pill contains the same active ingredient as Wegovy.

Some health experts said pills could reach people who are afraid of needles or patients who might benefit from the existing injections but don’t take them because they don’t view their need as severe enough. 

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 approval 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 share dominance.”

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

“Novo will likely benefit from first-mover advantage, capturing patients with a preference for convenience and comfort provided by an oral dosing regimen,” Seigerman said. But he also noted that the market is “rapidly evolving with competitive assets in development” and an approval for Eli Lilly’s pill, orforglipron, “just around the corner.”

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.

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

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

He added that the prices of the pill get costs closer to what some people are paying for unapproved, compounded versions of branded GLP-1s, some of which are still being illegally mass-marketed and sold in the U.S.

Patients flocked to the cheaper copycats when Ozempic and Wegovy were in short supply over the last two years due to skyrocketing demand, or if they didn’t have insurance coverage for the costly treatments. During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. But the agency earlier this year determined that the shortage of semaglutide is over, barring the practice in many cases.

“It continues to be alarming and disturbing for us,” Moore told CNBC, referring to illegitimate ingredients that are imported into the U.S. illegally and used by some compounding pharmacies to create copycat versions of branded GLP-1s.

In terms of manufacturing, Moore said the company is “prepared to be able to satisfy a big demand here in the U.S., and we’re pretty excited about it.” Novo Nordisk said manufacturing is underway at its North Carolina facilities.