The U.S. Food and Drug Administration on Monday approved manufacturer Wegovy’s first-ever GLP-1 obesity pill. Novo Nordiska historic decision that health experts say could open access to treatment to more patients.
Novo Nordisk said it plans to launch the pill in early 2026. The Danish drugmaker said that starting in early January, the starting dose of 1.5 milligrams will be available at pharmacies and through some telehealth providers with savings offers of $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 website, TrumpRx, under a deal Novo Nordisk struck with his administration last month. Trump’s site will also launch 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 would also be available at that time.
Shares of Novo Nordisk gained about 10% in extended trading on 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 who are obese and have established cardiovascular disease, according to Novo Nordisk. This is consistent with the approval label for the company’s blockbuster weight loss drug, Wegovy, which shares the same active ingredient, semaglutide.
“What we’ve learned over years of research is that having an oral option opens up, activates and motivates different segments to seek treatment,” Dave Moore, executive vice president of Novo Nordisk’s U.S. operations, told CNBC ahead of approval. “Have that conversation with their doctor to see if this is something that might be right for them.”
“That’s what we’re passionate about: being able to give people an option and ensure that we have access and ease of access like we did with our injections,” he continued.
It’s unclear how many people use GLP-1 in the United States, particularly to combat obesity. But about 1 in 8 adults said they were taking a GLP-1 drug to lose weight or treat another chronic illness in November, according to a poll by health policy research organization KFF.
The move gives Novo Nordisk a head start over its main rival. Eli Lilly, which is currently the dominant player in the market and is rushing to launch its own anti-obesity pill. Pills are the next battleground for the two drugmakers, who created the booming GLP-1 industry that some analysts say could be worth about $100 billion by the 2030s.
Wall Street thinks there’s plenty of room for pills in the market, with a Goldman Sachs analyst saying 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 the approval of Novo Nordisk’s pill gives the company a “well-deserved victory in light of recent challenges in maintaining growing market share dominance.”
Incretins refer to treatments that mimic gut hormones such as GLP-1. Eli Lilly gained the majority of market share earlier this year with its blockbuster obesity injection, Zepbound, which was found to be more effective than Novo Nordisk’s Wegovy.
“Novo will likely benefit from first-mover advantage, capturing patients with a preference for the convenience and comfort provided by an oral dosing regimen,” Seigerman said. But he also noted that the market is “moving rapidly with competitive assets in development” and approval of Eli Lilly’s pill, or forglipron, is “fast approaching.”
The approval is based on a phase three trial that followed more than 300 adults who were obese but did not have 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. 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 awaiting FDA approval.
But unlike Novo Nordisk’s pill, Eli Lilly’s treatment is not a peptide drug. This means that it is absorbed more easily by the body and does not require any dietary restrictions. People taking the Novo Nordisk pill should wait 30 minutes every day before eating or drinking.
Moore said the pill’s prices bring costs closer to what some people pay for compounded, unapproved versions of brand-name GLP-1, some of which are still mass-marketed and sold illegally in the United States.
Patients flocked to the cheaper copiers when Ozempic and Wegovy were in shortage over the past two years due to skyrocketing demand, or if they lacked insurance coverage for the expensive treatments. During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. But the agency determined earlier this year that the semaglutide shortage was over, ruling out the practice in many cases.
“This continues to be alarming and concerning to us,” Moore told CNBC, referring to illegitimate ingredients being illegally imported into the United States and used by some compounding pharmacies to create copycat versions of branded GLP-1s.
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