The logo of the pharmaceutical company Novo Nordisk is displayed in front of the company’s office in Bagsvaard, a suburb of Copenhagen, Denmark, on November 24, 2025.
Tom Little | Reuters
The U.S. Food and Drug Administration on Monday approved the first-ever GLP-1 pill to treat obesity, from the manufacturer Wegovy. novo nordiskThis is a landmark decision, which medical experts say has the potential to expand access to treatment to more patients.
Novo Nordisk said it plans to launch the pill in early 2026. The Danish drugmaker said starting doses of 1.5 milligrams will be available in pharmacies and through some telemedicine providers at a discounted price of $149 per month starting in early January.
That’s the same price that cash-paying patients can access starting doses of the pill on President Donald Trump’s direct-to-consumer website TrumpRx under an agreement Novo Nordisk struck with the administration last month. President Trump’s website will also be launched in January.
Novo Nordisk did not say how much the higher-dose drug would cost, but said additional information about coverage and savings options for eligible patients would also be available at that time.
Novo Nordisk shares rose about 10% in extended trading Monday.
Novo Nordisk said the FDA’s approval also allows the pill to be used to reduce the risk of serious cardiovascular events such as death, heart attack, and stroke in adults with obesity or a history of cardiovascular disease.
This is in line with the approved label for the company’s blockbuster weight loss drug Wegovy, which shares the same active ingredient semaglutide. Both suppress appetite by mimicking the intestinal hormone GLP-1.
“What we’ve learned through years of research is that having an oral treatment option really opens up, activates and motivates different populations to seek treatment,” Dave Moore, Novo Nordisk’s executive vice president of U.S. operations, told CNBC ahead of the approval. “To talk to their doctor and see if this is right for them.”
“That’s what we’re excited about: giving people a choice and being able to make sure they have access and make it accessible, like we’ve done with the injection,” he continued. He added that the tablets contain the same active ingredients as Wegobee, giving patients “peace of mind and familiarity” in terms of safety and effectiveness.
Some medical experts said the pills could end up reaching people who are afraid of needles or patients who might benefit from existing shots but aren’t taking them because they think their need is less severe.
It’s unclear exactly how many people in the United States are using GLP-1, specifically to treat obesity. But as of November, about one in eight adults said they were taking GLP-1 drugs to lose weight or treat other chronic conditions, according to a poll by KFF, a health policy research institute.
The approval gives Novo Nordisk a head start against its biggest rival. Eli Lilly, The company is currently the dominant player in the market and is rushing to launch its own obesity drug. Pills are the next battleground for the two drugmakers, establishing a fast-growing GLP-1 field that some analysts say could be worth about $100 billion by the 2030s.
Wall Street believes there is plenty of room for pills in the market, with Goldman Sachs analysts saying in August that they could capture a 24% share of the global weight-loss drug market in 2030, worth about $22 billion.
BMO Capital Markets analyst Evan Sagerman said in a note Monday that Novo Nordisk’s approval of the pill gives the company a “long-awaited victory given recent challenges in maintaining its incretin market share dominance.”
Incretin refers to treatments that mimic gut hormones such as GLP-1. Eli Lilly grabbed a majority share of the market earlier this year thanks to its blockbuster obesity drug Zepbound, which was found to be more effective than Novo Nordisk’s WeGoby.
“Novo is likely to benefit from first-mover advantages by capturing patients who prefer the convenience and comfort of oral administration,” Sagerman said. But he also said the market is “rapidly evolving with the development of competitive assets” and that approval for Eli Lilly’s pill Orforglipron is “just around the corner.”
What you need to know about Wegovy Pill
The approval was based on a Phase 3 study that followed more than 300 obese adults without diabetes.
The study showed that administration of 25 milligrams of Novo Nordisk’s oral semaglutide reduced patients’ weight by an average of up to 16.6% after 64 weeks, according to trial results presented at the 2024 Medical Congress. When the company analyzed all patients, regardless of whether they stopped taking the drug, weight loss was 13.6%.
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’s pill, Eli Lilly’s treatment is not a peptide drug. This means that it is easily absorbed by the body and does not require dietary restrictions. People taking Novo Nordisk tablets must wait 30 minutes before eating or drinking each day.
However, Moore said some existing medicines have the same dietary requirements, so “we don’t expect that to impact treatment compliance.” He pointed to a study by Novo Nordisk that found patients could remember to take their medication by simply drinking a few sips of water in the morning.
“It’s actually a reinforcing factor for the patient,” Moore said.
He added that the price of the pills is approaching the cost some people are paying for unapproved compounded versions of branded GLP-1, some of which are still illegally sold in bulk in the United States.
Over the past two years, when surging demand left Ozempic and Wegovy in short supply, or when insurance coverage for expensive treatments was lacking, patients flocked to cheaper knockoffs. If the FDA declares a shortage, pharmacists can legally manufacture compounded versions of branded drugs. But earlier this year, authorities determined that the shortage of semaglutide had ended and its use would be banned in many cases.
“This continues to be a concerning and alarming situation for us,” Moore told CNBC, referring to illegal ingredients that are illegally imported into the United States and used by some dispensaries to make counterfeit products of the brand GLP-1.
Regarding manufacturing, Moore said the company is “ready and excited to meet the huge demand here in the United States.” Novo Nordisk said manufacturing is underway at its North Carolina facility.
