The Food and Drug Administration on Monday approved a pill version of Wegovy, Novo Nordisk’s hit weight-loss drug.
The Wegovy pill, as it is called, is the first oral version of a GLP-1 drug to be marketed 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 from Ozempic and Novo Nordisk’s Wegovy, and tirzepatide, the drug from Mounjaro and Lilly’s Zepbound, have gained popularity in recent years. The compounds, initially approved for diabetes, may also offer significant weight loss.
All medications come in injectable form. (Novo Nordisk makes a pill version of semaglutide, called Rybelsus, for diabetes. It comes in a lower dose than the new version for weight loss.)
“This is an important step forward in this field,” said Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in Cary, North Carolina. “It won’t replace injectables, but it expands our tool set significantly.”
“Pills are familiar, non-intimidating and fit more naturally into most people’s routines,” McGowan added. “For many patients, a pill is not only easier, but psychologically more acceptable.”
Novo Nordisk has not published a list price for the pill, which must be taken daily, but is expected to be cheaper than weekly injections. Questions remain about insurance coverage; Many private insurers restrict coverage of the injections because of their high cost. Medicare, by law, is prohibited from covering weight-loss drugs, but the pill was also approved to reduce the risk of heart disease, which Medicare does cover.
In November, Novo Nordisk struck a deal with the Trump administration to sell the lowest dose of the pill for $149 a month to people paying out of pocket, in exchange for a tariff break. Lilly reached a similar deal for its weight-loss pill.
Like injections, the pill will come in various doses. Typically, people start with the lowest dose and gradually increase it over several weeks to adjust to 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 taking the highest dose of the Wegovy pill lost 16.6% of their body weight, on average, after 64 weeks, compared to a 2.2% weight loss in the placebo group.
This is roughly on par with the injectable version of Wegovy, which in clinical trials was shown to reduce weight by approximately 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 likely be adherence: The pill should 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 did not follow the strict program 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 schedule? Will they stay long enough to see significant results? We don’t know yet.”
As with GLP-1 injections, the most common side effects reported in the trial were gastrointestinal, including nausea and vomiting. In some cases, the side effects of the pill version can feel “more intense,” McGowan said, because the medication hits the stomach all at once and can cause nausea.
“The challenges we see with injectable GLP-1 don’t magically go away with a tablet,” he said.
While the weight loss experienced with the Wegovy pill was on par with the injection, Levy said that overall, oral GLP-1 medications generally do not cause 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 has not yet been approved, caused an average weight loss of 24% after 48 weeks.
“Zepbound maintains its status as the best medical treatment for obesity, second only to weight loss surgery in terms of results,” Levy said.
Novo Nordisk says differences in weight loss may be due to swallowing a pill. The body breaks down a portion of the pill as it moves through the digestive tract, so less medication reaches the bloodstream compared to an injection. To counteract this, the pill comes in higher doses than injections and must be taken daily, rather than a weekly injection.
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.
These are not direct comparisons because the drugs were not compared in a head-to-head clinical trial.
The company expects the Wegovy pill to be widely available in January, according to a Novo Nordisk spokesperson.
When Wegovy was first approved, it faced a prolonged shortage. To make up for the shortage this time, the company increased production of the pill in preparation for its launch, the spokesperson said.
McGowan said oral formulations are typically easier to manufacture than injectables, which could help avoid shortages.
