The Food and Drug Administration on Monday approved a pill version of Wegovy, Novo Nordisk’s blockbuster weight loss drug.
The Wegovy pill, as it’s called, is first oral version of a GLP-1 drug that has been brought to market for weight loss. A second pill, from Eli Lilly, is also expected to be approved in the coming months.
GLP-1 drugs — which include semaglutide, the drug in Novo Nordisk’s Ozempic and Wegovy, and tirzepatide, the drug in Lilly’s Mounjaro and Zepbound — have soared in popularity in recent years. The compounds, initially approved for diabetes, can also offer significant weight loss.
The drugs all come in an injectable form. (Novo Nordisk does make one pill version of semaglutide, called Rybelsus, for diabetes. It comes in a lower dose than the new version for weight loss.)
“This is a meaningful step forward in the field,” said Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in Cary, North Carolina. “It won’t replace injectables, but it broadens our tool kit in an important way.”
“Pills are familiar, nonintimidating and fit more naturally into most people’s routines,” McGowan added. “For many patients, a pill isn’t just easier, it’s psychologically more acceptable.”
Novo Nordisk hasn’t released the list price for the pill, which must be taken daily, but it’s expected to be cheaper than the weekly injections. Questions about insurance coverage remain; many private insurers restrict coverage of the injections because of their high cost. Medicare, by law, is barred from covering weight loss drugs, but the pill was also approved for lowering heart disease risk — which Medicare does cover.
In November, Novo Nordisk reached a deal with the Trump administration to sell the lowest dose of the pill for $149 a month for people who pay out of pocket, in exchange for tariff relief. Lilly made a similar agreement for its weight loss pill.
Like the injections, the pill will come in several doses. People typically start at the lowest dose and gradually increase over several weeks to adjust to any side effects.
How well does the Wegovy pill work?
Phase 3 clinical trial results published in the New England Journal of Medicine found that people who took the highest dose of the Wegovy pill lost 16.6% of their body weight, on average, after 64 weeks, compared with 2.2% weight loss in the placebo group.
That’s roughly on par with the injectable version of Wegovy, which was shown in clinical trials to reduce weight by about 15% after 68 weeks.
Dr. Shauna Levy, medical director of the Tulane Weight Loss Center, said the biggest challenge for people who opt for the pill version will most likely be adherence: The pill must be taken first thing in the morning, on an empty stomach, with no more than 4 ounces of water.
People in the clinical trial who didn’t stick to the strict schedule lost less weight, 13.6% of their body weight on average.
The open question is “real-world performance,” McGowan said. “Will patients tolerate the daily dosing and strict timing? Will they stay on long enough to see meaningful results? We don’t know yet.”
As with GLP-1 injections, the most common reported side effects in the trial were gastrointestinal, including nausea and vomiting. In some cases, the side effects from the pill version may feel “more intense,” McGowan said, because the medication hits the stomach all at once and can trigger nausea.
“The challenges we see with injectable GLP-1s don’t magically disappear with a tablet,” he said.
While the weight loss experienced with the Wegovy pill was on par with that of the injection, Levy said that in general, oral GLP-1 drugs usually don’t lead to as much weight loss as the newer injections.
Lilly’s Zepbound helped people lose 22.5% of their body weight on average after 72 weeks in clinical trials. And Lilly’s next-generation injection, retatrutide — which hasn’t yet been approved — led to average weight loss of 24% after 48 weeks.
“Zepbound maintains its status as the best medical treatment for obesity, only inferior to weight loss surgery in terms of outcomes,” Levy said.
Novo Nordisk says the differences in weight loss may come down to the fact that a pill is swallowed. The body breaks down part of the pill as it moves through the digestive tract, so less of the medication makes it into the bloodstream compared with an injection. To counter that, the pill comes in a higher dose than injections and must be taken daily, rather than a weekly shot.
The Wegovy pill is closer in effectiveness to Lilly’s orforglipron, which helped people lose about 10.5% of their body weight after 72 weeks in a late-stage trial.
Those aren’t direct comparisons because the drugs weren’t compared in a head-to-head clinical trial.
The company expects the Wegovy pill to be available widely in January, a Novo Nordisk spokesperson said.
When Wegovy was first approved, it faced prolonged shortages. To offset shortages this time, the company boosted production of the pill in preparation for its launch, the spokesperson said.
McGowan said oral formulations are often easier to manufacture than injectables, which could help avoid shortages.
