The US Food and Drug Administration (FDA) has approved the first GLP-1 obesity tablet from Wegovy manufacturer Novo Nordisk.

The U.S. Food and Drug Administration on Monday approved Wegovy’s first GLP-1 obesity pill Novo NordiskIt is a historic decision that health experts say may open the way for treatment for more patients.

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

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

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

Novo Nordisk shares rose nearly 10% in extended trading Monday.

The FDA approval also allows the pill to be used to reduce the risk of major cardiovascular events, such as death, heart attack or stroke, in adults with obesity and cardiovascular disease, according to Novo Nordisk.

This matches the approval mark for the company’s blockbuster weight-loss drug Wegovy, which shares the same active ingredient, semaglutide. They both work by mimicking the gut hormone GLP-1 to suppress appetite.

“What we’ve learned through years of research is that having a verbal option kind of opens up and activates and motivates different segments to seek treatment,” Dave Moore, executive vice president of Novo Nordisk’s U.S. operations, told CNBC before the approval. “To have that conversation with their doctor to see if this is the right thing for them.”

“That’s what we’re excited about — being able to give people a choice and making sure that we have the accessibility and ease of access that we had with our injections,” he continued. He added that patients will gain “comfort and familiarity” in terms of safety and effectiveness because the pills contain the same active ingredient as Wegovy.

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

It’s not clear exactly how many people use GLP-1s in the United States, especially to treat obesity in particular. But about 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 by health policy research organization KFF.

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

Wall Street believes there is plenty of room for the pill in the market, with a Goldman Sachs analyst saying in August that the pill 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 Segerman 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.”

Incretin refers to treatments that mimic gut hormones such as GLP-1. Eli Lilly earlier this year claimed majority market share with its blockbuster obesity injection Zepbound, which was shown to be more effective than Novo Nordisk’s Wegovy.

“Novo will likely benefit from first-mover advantage, capturing patients who prefer the convenience and convenience of an oral dosing regimen,” Segerman said. But he also noted that the market is “evolving rapidly with competitive assets in development” and that approval of Eli Lilly’s birth control pill, Orforglipron, is “just around the corner.”

The approval is based on a phase 3 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. Weight loss was 13.6% when the company analyzed all patients regardless of whether they had stopped taking the drug.

The pill appears to be slightly more effective than Eli Lilly’s experimental oral drug, which is still awaiting FDA approval.

But unlike Novo Nordisk pills, Eli Lilly’s treatment is not a peptide drug. This means that it is more easily absorbed by the body and does not require dietary restrictions. People taking Novo Nordisk pills should wait 30 minutes before eating or drinking each day.

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

“It’s actually an empowering factor for patients,” Moore said.

He added that pill prices bring costs closer to what some people pay for unapproved compounded versions of branded GLP-1s, some of which are still widely marketed and sold illegally in the United States.

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

“It’s still concerning and disturbing to us,” Moore told CNBC, referring to illicit ingredients being imported into the United States illegally and used by some compounding pharmacies to create counterfeit versions of branded GLP-1s.

Regarding manufacturing, Moore said the company is “prepared to be able to meet the significant demand here in the United States, and we’re very excited about that.” Novo Nordisk said manufacturing is underway at its facility in North Carolina.