FDA approves Wegovy weight-loss pill from Novo Nordisk

The U.S. Food and Drug Administration on Dec. 22 approved a pill version of Novo Nordisk’s weight-loss drug Wegovy, the first daily oral medication for obesity treatment.

The once-daily tablet — called the Wegovy pill — is the "first and only" oral GLP-1 medicine, or glucagon-like peptide-1, receptor agonists, according to Novo Nordisk. GLP-1 drugs were first used to treat diabetes but have since been approved to treat obesity, which has dramatically expanded the patient pool.

"Wegovy pill is the next chapter in our decades-long GLP-1 experience—supported by the most affordable self-pay price to date in a GLP-1 for obesity," Dave Moore, executive vice president of U.S. Operations at Novo Nordisk, said in a statement. "We are prepared for a full US launch in early January 2026, with manufacturing well underway in our North Carolina facilities."

The pill is 25 milligrams of semaglutide, the same active ingredient in injectable Wegovy and Ozempic. Novo Nordisk already sells an oral semaglutide for type 2 diabetes, Rybelsus.

The Wegovy pill was approved for chronic weight management in adults with obesity or overweight and at least one related health condition. GLP-1 medications mimic the natural hormone and reduce people's appetite, helping them lose weight.

The approval of the pill gives Novo Nordisk a boost in the race to market an oral medication for obesity treatment. The Danish drugmaker's rival, Eli Lilly, has oral medication still under review and could be approved as soon as late March.

Wegovy pill will be available in the coming weeks

In a news release, Novo Nordisk said the FDA's approval of the Wegovy pill was based on results from a 64-week, late-stage medical study.

Results from the study, which included over 300 adult participants, showed that participants who took the pill once daily lost an average of 16.6% of their body weight, compared with 2.7% for those on a placebo.

The company noted that the pill is used with a reduced-calorie diet and increased physical activity for adults with obesity or who are overweight. The pill also needs to be taken in the morning on an empty stomach, 30 minutes before eating, drinking or using any other oral medication.

The 1.5-milligram starting dose of the pill will be available in early January, Novo Nordisk said.

Weight-loss pill could expand access for obesity treatment

A survey released by the Gallup National Health and Well-Being Index in October revealed that the adult obesity rate in the United States gradually declined to 37% in 2025, dropping from a record high of 39.9% in 2022.

New research has shown that injectable weight loss drugs, such as Wegovy and Ozempic, may have contributed to the decline. The survey found that the usage of GLP-1 drugs among both men and women more than doubled in the past year, with 12.4% of respondents saying they used the drugs compared with 5.8% in February 2024.

GLP-1 drugs were first approved in 2005 to treat diabetes, and Novo Nordisk was the first company to be approved to market GLP-1 drugs for weight loss. The FDA approved Saxenda, a daily injection, for the treatment of obesity in 2014 and Wegovy in 2021.

In recent years, Novo Nordisk’s injectable Wegovy and Eli Lilly's Zepbound have transformed obesity treatment across the world. Earlier this month, the World Health Organization released a global guideline on the use of GLP-1 medicines in treating obesity.

Dr. Tedros Adhanom Ghebreyesus, the director-general of the WHO, noted that while medication alone will not solve the health crisis, "GLP-1 therapies can help millions overcome obesity and reduce its associated harms."

Analysts have said a weight-loss pill would address patient hesitancy over injections, which some consider invasive, and broaden access amid high healthcare costs related to obesity treatment.

"The pills will not displace or replace the injections," Christopher Chrisman, a managing director and partner at consultancy BCG, told Reuters. He added that some patients may prefer to continue with weekly injections.

"But pills offer clear advantages to some people. There's travel convenience and no need for a fridge," Chrisman said.

Contributing: Nicole Fallert, Eduardo Cuevas and Ken Alltucker, USA TODAY; Reuters