US regulators approve Wegovy pill for weight loss
[December 23, 2025]
By JONEL ALECCIA
U.S. regulators on Monday gave the green light to a pill version of the
blockbuster weight-loss drug Wegovy, the first daily oral medication to
treat obesity.
The U.S. Food and Drug Administration’s approval handed drugmaker Novo
Nordisk an edge over rival Eli Lilly in the race to market an obesity
pill. Lilly’s oral drug, orforglipron, is still under review.
Both pills are GLP-1 drugs that work like widely used injectables to
mimic a natural hormone that controls appetite and feelings of fullness.
In recent years, Novo Nordisk’s injectable Wegovy and Lilly’s Zepbound
have revolutionized obesity treatment globally and in the U.S., where
100 million people have the chronic disease.
The Wegovy pills are expected to be available within weeks, company
officials said. Availability of oral pills to treat obesity could expand
the booming market for obesity treatments by broadening access and
reducing costs, experts said.
About 1 in 8 Americans have used injectable GLP-1 drugs, according to a
survey from KFF, a nonprofit health policy research group. But many more
have trouble affording the costly shots.
“There’s an entire demographic that can benefit from the pills,” said
Dr. Fatima Cody Stanford, a Massachusetts General Hospital obesity
expert. “For me, it’s not just about who gets it across the finish line
first. It’s about having these options available to patients.”
The Novo Nordisk obesity pill contains 25 milligrams of semaglutide.
That's the same ingredient in injectables Wegovy and Ozempic and in
Rybelsus, a lower-dose pill approved to treat diabetes in 2019.
In a clinical trial, participants who took oral Wegovy lost 13.6% of
their total body weight on average over about 15 months, compared with a
2.2% loss if they took a placebo, or dummy pill. That’s nearly the same
as injectable Wegovy, with an average weight loss of about 15%.
Chris Mertens, 35, a pediatric lung doctor in Menomonee Falls,
Wisconsin, joined the Novo Nordisk trial in 2022 and lost about 40
pounds using the Wegovy pill. The daily medication worked to decrease
his appetite and invasive thoughts of food, he said.
“If there were days where I missed a meal, I almost didn’t realize it,”
Mertens said.
Participants in a clinical trial who took the highest dose of Lilly’s
orforglipron lost 11.2% of their total body weight on average over
nearly 17 months, compared with a 2.1% loss in those who took a placebo.
Both pills resulted in less weight loss than the average achieved with
Lilly’s Zepbound, or tirzepatide, which targets two gut hormones, GLP-1
and GIP, and led to a 21% average weight loss.
All the GLP-1 drugs, oral or injectable, have similar side effects,
including nausea and diarrhea.
Both daily pills promise convenience, but the Wegovy pill must be taken
with a sip of water in the morning on an empty stomach, with a 30-minute
break before eating or drinking.
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The U.S. Food and Drug Administration building is seen behind FDA
logos at a bus stop on the agency's campus in Silver Spring, Md.,
Aug. 2, 2018. (AP Photo/Jacquelyn Martin, File)
 That’s because Novo Nordisk had to
design the pill in a way that prevented the drug from being broken
down in the stomach before it could be absorbed by the bloodstream.
The drugmaker added an ingredient that protects the medication for
about 30 minutes in the gut and makes it easier to take effect.
By contrast, Lilly’s orforglipron has no dosing restrictions. That
drug is being considered under the FDA’s new priority voucher
program aimed at cutting drug approval times. A decision is expected
by spring.
Producing pills is generally cheaper than making drugs delivered via
injections, so the cost for the new oral medications could be lower.
The Trump administration earlier this year said officials had worked
with drugmakers to negotiate lower prices for the GLP-1 drugs, which
can cost upwards of $1,000 a month.
The company said the starting dose would be available for $149 per
month from some providers. Additional information on cost will be
available in January.
It’s not clear whether daily pills or weekly injections will be
preferred by patients. Although some patients dislike needles,
others don't seem to mind the weekly injections, obesity experts
said. Mertens turned to injectable Zepbound when he regained weight
after the end of the Wegovy pill clinical trial.
He said he liked the discipline of the daily pill.
“It was a little bit of an intentional routine and a reminder of
today I’m taking this so that I know my choices are going to be
affected for the day,” he said.
Dr. Angela Fitch, an obesity expert and chief medical officer of
knownwell, a health care company, said whatever the format, the
biggest benefit will be in making weight-loss medications more
widely accessible and affordable.
“It’s all about the price,” she said. “Just give me a drug at $100 a
month that is relatively effective.”
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