FDA Approves Pill Version of Wegovy

The US Food and Drug Administration today approved a pill version of the blockbuster anti-obesity drug Wegovy. Made by Novo Nordisk, the pill is taken once a day. The company’s original version of Wegovy is a weekly injection. Both drugs contain the same active ingredient, semaglutide.

“This allows patients with obesity who want to lose weight to have a choice between a once weekly injection or a daily tablet,” says Martin Holst Lange, chief scientific officer at Novo Nordisk.

With the soaring popularity of injectable GLP-1 drugs for weight loss, Novo Nordisk and other pharmaceutical companies have been racing to make effective pill versions that could be preferable for some patients. These drugs mimic a naturally occurring hormone in the body that acts on the brain and gut to promote a feeling of fullness.

In clinical trial results published in the New England Journal of Medicine, participants who took the pill achieved an average weight loss of 13.6 percent by 64 weeks. Nearly 30 percent of people lost 20 percent or more of their weight. The study also showed improvements in cardiovascular disease risk and physical activity levels similar to the injectable version.

While pills can sometimes be a more convenient option, patients may not always take them as prescribed, making them less effective. The clinical trial investigators estimated that in an ideal scenario where participants take the pill every day as prescribed, weight loss would be 16.6 percent—which is similar to results seen with injectable Wegovy.

Novo Nordisk first won approval for an oral semaglutide, sold under the brand name Rybelsus, in 2019 to treat type 2 diabetes. That drug has never been approved for obesity and is not as effective for weight loss as newer GLP-1 medications. The Wegovy pill is essentially a higher-dose version of Rybselsus.

“The efficacy for the obesity pill at the end of the day is driven by dose. Higher doses are required to achieve full weight-loss potential for obesity,” Lange says. The Wegovy pill is 25 milligrams while Rybelsus is 14 milligrams.

The most common side effects of oral Wegovy include nausea and vomiting, which are also side effects of the injectable version.

Novo says the starting dose of the pill, 1.5 milligrams, will be available in early January for $149 per month with savings offers. Production of the medication is already underway at Novo Nordisk’s US manufacturing sites, and the company expects to have enough of the drug to meet US demand.

Eli Lilly, which makes Mounjaro and Zepbound, is also working on a daily GLP-1 pill, called orforglipron. In trial results announced in August, the pill lowered weight in individuals with obesity by an average of 12.4 percent of body weight. That makes it less effective than injectables, which yield 15 to 20 percent weight loss. Unlike the Wegovy pill, orforglipron has no food or water restrictions. Eli Lilly has said it will submit orforglipron for FDA approval by the end of this year.

“What we’ve seen so far is that there’s not too much difference between the diabetes costs for the oral and the injectable versions,” says Tim Blackstock, a pharmaceutical industry analyst at Citeline. “So we suspect it might not be too much different in the obesity space, especially if the drugs are offering similar efficacy.”

Update, Monday December 22 at 7:25 pm: The story was updated with pricing and availability for the Wegovy pill.