The U.S. Food and Drug Administration has approved a pill version of Novo Nordisk’s blockbuster weight-loss drug Wegovy, marking the first daily oral medication approved for the treatment of obesity.
Cleared on Dec. 22, the once-daily tablet—known as the Wegovy pill—becomes the first and only oral GLP-1 (glucagon-like peptide-1) receptor agonist authorized specifically for chronic weight management, according to the Danish pharmaceutical company. GLP-1 drugs were initially developed for diabetes but have since reshaped obesity treatment, dramatically broadening their use.
“Wegovy pill is the next chapter in our decades-long GLP-1 experience,” said Dave Moore, executive vice president of U.S. operations at Novo Nordisk. He added that the company is preparing for a full U.S. launch in early January 2026, with manufacturing already underway at its North Carolina facilities.
The pill contains 25 milligrams of semaglutide, the same active ingredient used in injectable Wegovy and diabetes drug Ozempic. Novo Nordisk already markets an oral form of semaglutide for type 2 diabetes under the brand name Rybelsus.
The FDA approved the Wegovy pill for adults with obesity, as well as those who are overweight and have at least one weight-related health condition. GLP-1 medications work by mimicking a naturally occurring hormone that regulates appetite, helping patients reduce food intake and lose weight.
The approval gives Novo Nordisk a competitive edge in the race to bring an oral obesity drug to market. Rival Eli Lilly has a similar pill still under FDA review, with a decision possible as early as late March.
Clinical Results and Rollout Timeline
In a statement, Novo Nordisk said the FDA’s decision was based on results from a 64-week late-stage clinical trial involving more than 300 adults. Participants who took the Wegovy pill once daily lost an average of 16.6% of their body weight, compared with 2.7% among those who received a placebo.
The company emphasized that the medication is intended to be used alongside a reduced-calorie diet and increased physical activity. Patients must take the pill in the morning on an empty stomach, at least 30 minutes before eating, drinking, or taking other oral medications.
Novo Nordisk said a 1.5-milligram starting dose will be available in early January, with broader availability expected in the coming weeks.
Expanding Access to Obesity Care
The approval comes as new data suggest obesity rates in the United States may be easing. According to the Gallup National Health and Well-Being Index, the adult obesity rate declined to 37% in 2025, down from a record 39.9% in 2022.
Researchers say the growing use of injectable GLP-1 drugs such as Wegovy and Ozempic may have contributed to the decline. Gallup found that GLP-1 usage among U.S. adults more than doubled over the past year, rising to 12.4% from 5.8% in early 2024.
GLP-1 medications were first approved in 2005 for diabetes treatment, and Novo Nordisk later became the first company to secure approval for weight-loss indications, starting with Saxenda in 2014 and Wegovy injections in 2021. In recent years, Novo Nordisk and Eli Lilly—maker of Zepbound—have transformed the global obesity treatment landscape.
Earlier this month, the World Health Organization released its first global guidelines on the use of GLP-1 drugs for obesity. WHO Director-General Dr. Tedros Adhanom Ghebreyesus cautioned that medication alone is not a cure-all but said GLP-1 therapies “can help millions overcome obesity and reduce its associated harms.”
Analysts say an oral option could further expand access by addressing patient reluctance toward injections and easing logistical challenges.
“The pills will not displace or replace the injections,” Christopher Chrisman, a managing director and partner at consultancy BCG, told Reuters. “But pills offer clear advantages to some people—there’s travel convenience and no need for refrigeration.”
With FDA approval secured, Novo Nordisk’s Wegovy pill is poised to become a major new entry in the fast-growing obesity drug market, potentially reshaping how millions approach long-term weight management.
