The Food and Drug Administration has approved the first GLP-1 pill for weight loss, its manufacturer Novo Nordisk announced Monday, a milestone in the growth of the revolutionary drugs.
The drug, a once-a-day Wegovy tablet, also is approved for reducing cardiovascular risk. The pill is expected to increase accessibility for people who don’t like injections.
“The pill is here,” Mike Doustdar, the Denmark-based drugmaker’s CEO, said in a statement.
Wegovy will soon face competition. Eli Lilly has sought FDA approval for its own weight-loss pill as the two pharmaceutical giants continue their battle for market share. Analysts expect the pills — which also are cheaper to make and ship than the injectable versions — to become instant blockbusters. Here’s what you need to know.
When can I get the Wegovy pill?
Novo Nordisk said it will start selling the starting dose of its pill in “early January,” but will not say what other doses will be available until the launch, according to a spokeswoman.
When the company launched the injectable version of Wegovy in March 2022, it couldn’t keep up with demand and the FDA placed the drug on its shortage list for more than two years, opening the door for compounding pharmacies to make cheaper versions and cutting into Novo Nordisk’s blockbuster sales. This time, the company says that “robust supply is on-hand.”
How much will it cost?
The starting dose of the Wegovy pill will be available for $149 a month, with the price for the three higher doses yet to be announced. The initial dose is cheaper than the lowest doses of the Wegovy injectable pen, which Novo Nordisk is offering for $199 a month to new customers paying cash through the end of March before reverting to at least $349 a month.
One thing to keep in mind: the weight-loss figures that Novo Nordisk touts, and that helped it win approval for the pill, are based on a clinical trial that studied the highest dose of 25 mg. The starting dose with that $149 price is 1.5 mg.
How much weight do patients lose on the Wegovy pill?
Participants who took the highest dose of the Wegovy pill lost an average of about 14 percent of their body weight over 64 weeks in the clinical trial, or about 11 percent more weight than patients who got a placebo. That is close to the amount patients lost in a clinical trial of the injectable form of Wegovy but falls short of the 20 percent weight loss achieved with Eli Lilly’s tirzepatide-based injectable Zepbound.
Doesn’t Novo Nordisk already offer a GLP-1 pill?
The company also makes Rybelsus, a GLP-1 pill approved to treat diabetes. The Wegovy pill is expressly approved for weight loss. Though both drugs contain the same active ingredient, semaglutide, the Wegovy tablet has a much higher maximum dose (25 mg) than Rybelsus (14 mg).
How does the Wegovy pill compare with Eli Lilly’s pill?
Eli Lilly said last week that it has asked the FDA to approve its GLP-1 pill, orforglipron, for treating obesity. Like Novo Nordisk, the company received a new, controversial type of voucher from the FDA designed to speed up approval of promising medicines. Financial analysts expect it will win approval and launch during the first half of 2026.
Patients taking orforglipron lost on average slightly less weight in a clinical trial than those taking the Wegovy pill, but it can be tricky comparing trials with different designs. Eli Lilly has emphasized orforglipron’s convenience; while Wegovy tablets are supposed to be taken on an empty stomach in the morning with up to four ounces of water, orforglipron has no restrictions on eating or drinking.
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