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FDA Approves New Weight Loss Pill

People looking to lose or maintain their weight now have another GLP-1 option


A close-up shot of white Novo Nordisk oral Wegovy pills in a production tray, the first FDA-approved GLP-1 weight loss pill.
Novo Nordisk A/S: Wegovy® pill approved in the US as first oral GLP-1 for weight management
Courtesy Novo Nordisk

Health regulators have approved the first pill form of the blockbuster drug Wegovy, providing patients with a new option for weight loss and management that eliminates the need for regular injections.

The once-daily Wegovy pill is the first oral GLP-1 to gain federal approval for weight loss. In clinical trials, participants who took the highest dose of the pill lost an average of 16.6 percent of their body weight (approximately 32 pounds for a 200-pound person) after 64 weeks, the drug’s manufacturer, Novo Nordisk, said in a Dec. 22 news release.

One in three people taking the oral medication lost at least 20 percent of their body weight. The trial results were published in September in The New England Journal of Medicine.

Novo Nordisk says the weight loss achieved with the Wegovy pill is comparable to that of the injectable version. Side effects are similar too: Many participants in the trial reported gastrointestinal issues, such as nausea and vomiting, when taking the medication.

A pill containing a much lower dose of the same active ingredient in the Wegovy pill (semaglutide) is approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes. Its weight loss effect, however, is far less pronounced. 

Novo Nordisk expects to launch the Wegovy pill in early January. The pill is also approved to help reduce the risk of serious cardiovascular events like nonfatal heart attacks and strokes.

Expanding options for patients 

Wegovy may be the first GLP-1 pill to receive federal approval for weight loss, but it is likely not the last.

Eli Lilly, which manufactures Mounjaro and Zepbound (tirzepatide), is seeking FDA approval for its own oral weight management option, orforglipron. The company is also studying the pill for treatment of type 2 diabetes.

Expanding the pool of available options could help meet consumer demand more effectively. The active ingredients used to make Wegovy and Zepbound were in short supply for years. A recent poll among older adults found that 63 percent of people ages 50 to 80 who say they are overweight are interested in taking prescription weight-loss medications.

While some people may prefer a weekly injection, Dr. Chetna Bakshi, a bariatric surgeon at Northwell Health’s Syosset Hospital in New York, told AARP that adding a pill to the mix could “offer more options for those patients who are unable to do the injections.”

It could also be a preferable option for people who travel frequently, as the injectable medications require refrigeration. “A pill is very easy to take with you, so it definitely allows for more options for patients,” Bakshi says.

Still, it’s not hassle-free. For example, you have to take the Wegovy pill first thing on an empty stomach and wait 30 minutes before eating or drinking.

Another potential plus: cost. While the injectable GLP-1 drugs can cost up to $1,000 a month, the price tag on the pills is expected to be lower for people paying out of pocket. (Novo Nordisk has not yet published the list price of the Wegovy pill.) Many insurance plans, including Medicare, do not cover medications strictly for weight loss.

In November, the Trump administration announced a deal with Novo Nordisk to offer the Wegovy pill at $150 a month for a starting dose through TrumpRx, a direct-to-consumer website slated to launch in early 2026. The injectable form of Wegovy will cost $350 when purchased through TrumpRx, the White House said. Eli Lilly’s weight loss products — including its pill, if approved — were also part of the administration’s price negotiations.

While we wait for oral options to come to market, health experts say it’s important to talk to your health care provider about your weight loss goals and options if you’re struggling to lose weight.

GLP-1 treatments are not for everyone, Bakshi stresses, and like all medications, they can cause unpleasant side effects. What’s more, they are not recommended for patients with certain health conditions, including a history of medullary thyroid cancer.

“There’s no miracle drug. Everything comes with risks, everything comes with complications,” Bakshi says.

Editor’s note: An earlier version of this article was first published on July 3, 2023.

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