Listen to this articleThe basics:
- FDA approves once-daily oral version of Novo Nordisk‘s Wegovy for weight loss
- Pill is the first oral GLP-1 obesity drug to reach the US market
- Phase 3 trial showed up to 16.6% weight loss over 64 weeks
- Starting doses priced at $149 per month, with domestic launch planned for early 2026
The U.S. Food and Drug Administration approved a once-daily pill version of Novo Nordisk’s blockbuster GLP-1 weight loss drug Wegovy.
The FDA made the decision Dec. 22. The starting dose of 1.5 milligrams will be available in pharmacies and via select telehealth providers starting early next month, according to the Danish drugmaker.
The approval also makes Novo Nordisk the first pharmaceutical company to bring an oral GLP-1 for weight loss to market.
Eli Lilly recently said it anticipates its candidate to secure FDA approval in 2026.
A semaglutide-based drug, Wegovy was first approved in June 2021 specifically for chronic weight management in individuals who are obese or overweight with at least one weight-related condition, such as high blood pressure, Type 2 diabetes or high cholesterol. Administered through injector pens in once-weekly dosing, Novo Nordisk says patients should pair the drug with diet and exercise changes to lose weight and keep it off.
Compared with injectables, oral medications are cheaper to manufacture and generally easier for patients to administer. As a result, pharmaceutical companies are racing to bring a weight loss pill to the GLP-1 space, which is expected to be worth $100 billion by the 2030s, CNBC noted.
Roche and AstraZeneca are also trying to develop oral GLP-1s for weight loss. Pfizer, however, halted efforts on its pill after signs of liver toxicity in late-stage clinical testing, BioPharma Dive reported.
‘The next chapter’
In May, Novo Nordisk announced seeking regulatory approval of an oral version of Wegovy for weight management. The company also said it expected the decision by the end of the year.
According to the company, this week’s FDA approval also clears the pill for use to reduce the risk of major cardiovascular events, such as death, heart attack or stroke, in adults with obesity and established cardiovascular disease.
The pharma giant already has one GLP-1 available in pill form under the name Rybelsus. The FDA authorized that drug in 2019 for blood sugar control in adults with diabetes.
In a statement, Novo Nordisk Executive Vice President of U.S. Operations Dave Moore said, “The launch of Wegovy in 2021 changed how obesity was viewed and treated in the US. Now, with Wegovy pill, we are offering a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in phase 3 trials.”
“We are confident that the expansion of Wegovy to a pill will help patients who may have not sought or accepted treatment before,” he said. “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. We are prepared for a full U.S. launch in early January 2026, with manufacturing well underway in our North Carolina facilities.”
We are confident that the expansion of Wegovy to a pill will help patients who may have not sought or accepted treatment before.
– Dave Moore, Novo Nordisk EVP of U.S. operations
The results are in
Novo Nordisk has its U.S. headquarters in Plainsboro. The company said the FDA based its approval on results from a Phase 3 trial of more than 300 adults with obesity.
During the 64-week study, patients who took the highest dose of the Wegovy pill lost 16.6% of their body weight compared with 2.2% in the placebo group. That’s on par with the injectable version of Wegovy. In clinical trials, that treatment reduced weight by about 15% after 68 weeks, results showed.
Drug agreements
Four New Jersey companies are among the latest to strike agreements with the White House to lower prescription costs under President Trump’s policy. Read more here.
The announcement comes about a month after Novo Nordisk became one of the latest pharmaceutical companies to strike deals with the White House to lower prescription drug costs.
As part of that agreement, the firm pledged to offer starting doses of its upcoming obesity pill at $149 a month for individuals on Medicare, Medicaid or using the soon-to-launch TrumpRx direct-to-consumer website. Eli Lilly made a similar deal for its weight loss pill.
In this week’s press release, Novo Nordisk said starting doses of the Wegovy pill will be available with savings offers for just $149 per month. Additional information on coverage and savings options for eligible patients, including other programs designed to help reduce out-of-pocket costs, will come out in early January 2026, Novo Nordisk said.
