U.S. regulators on Monday approved an oral version of Novo Nordisk’s weight-loss drug Wegovy, giving the Danish drugmaker an early lead in the race to offer a daily pill that expands access and lowers costs for patients, after the FDA approves oral Wegovy for U.S. use.
FDA Clears Once-Daily Pill as Affordable Option
The Food and Drug Administration approved the once-daily oral formulation of Wegovy, a GLP-1 agonist already sold as an injectable blockbuster for obesity and diabetes-related care. With the move in which the FDA approves oral Wegovy, Novo Nordisk said the pill is expected to launch in January.
The starting one point five milligram dose will cost $149 per month when purchased through pharmacies and select telehealth providers, factoring in savings offers. The oral drug is positioned as a lower-cost alternative to injectable Wegovy, which sells for $349 per month through Novo’s direct-to-consumer NovoCare Pharmacy, following the decision in which the FDA approves oral Wegovy.
In November, Novo agreed to sell oral Wegovy at the same $149 price on TrumpRx, a U.S. government-run website expected to launch by the end of the year. The agreement was part of a most-favored nation pricing deal with the Trump administration that also covers obesity drugs sold by rival Eli Lilly.
Both Novo Nordisk and Lilly received Commissioner’s National Priority Vouchers to speed development of oral GLP-1 drugs. Lilly filed for FDA approval last week for its oral contender, Orforglipron, shortly before the FDA approves oral Wegovy.
Novo Nordisk has said the lower price and easier administration of oral Wegovy are intended to reach more patients and improve access to obesity treatment in the United States.
Trial Data Show Pill Matches Injectable Results
The FDA approval was based on results from the Phase III OASIS four trial, which enrolled adults with a body mass index of 30 or higher, or at least 27 with one or more obesity-related conditions. The data supported the decision as the FDA approves oral Wegovy.
After sixty-four weeks, patients taking a daily twenty-five milligram dose of oral Wegovy lost an average of 13.6% of their body weight, compared with 2.2% for those receiving placebo. Novo later estimated that weight loss could reach about 16.6% with full treatment adherence, a result it described as comparable to injected Wegovy.
Physicians say the data help explain strong interest in oral options. In a recent FirstWord survey of U.S. and European endocrinologists and general practitioners, 85% said they were at least somewhat likely to prescribe oral Wegovy over the injectable version after the FDA approves oral Wegovy.
Amy Sheer, an assistant professor of medicine at the University of Florida, said the results stood out. “The data are compelling,” Sheer said in an interview following the trial readout. She described the pill as “an attractive option for patients and for physicians who are not always comfortable prescribing the injectables.”
Doctors surveyed cited improved adherence and patient comfort as key advantages of a daily pill over weekly injections.
Approval Lifts Stock as Competition Looms
The FDA decision and a roughly 10% after-hours jump in Novo Nordisk shares offered a boost to a company that has struggled in 2025, as investors reacted positively after the FDA approves oral Wegovy.
The company cut obesity sales forecasts multiple times this year, while Eli Lilly gained market share with its own injectable GLP-1 drugs. Investor confidence was further shaken by the surprise resignation of Novo CEO Lars Fruergaard Jørgensen.
Analysts widely view oral Wegovy as Novo’s biggest commercial opportunity in 2026, but competition is expected to intensify quickly. Lilly’s orforglipron and other oral obesity drugs are moving through late-stage development.
Given Novo’s steady loss of market share to Lilly throughout 2025, investors remain cautious about whether the company can maintain its early lead in what is shaping up to be a crowded market for oral weight-loss therapies.
