The Food and Drug Administration on Monday approved a tablet version of Wegovy, a popular weight-loss drug from Novo Nordisk.
The Wegovy tablet, as it is called, is the first oral version of the GLP-1 drug to be 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, including semaglutide, found in Novo Nordisk's Ozempic and Wegovy, and tirzepatide, in Lilly's Mounjaro and Zepbound, have surged in popularity in recent years. The compounds, originally approved for treating diabetes, can also provide significant weight loss.
All drugs are available in injection form. (Novo Nordisk does make one semaglutide tablet, called Ribelsus, to treat diabetes. Its dosage is lower than the new weight-loss version.)
“This is a significant 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 injections, but it will significantly expand our toolbox.”
“The pills are familiar, non-intimidating and fit more naturally into most people's daily routines,” McGowan added. “For many patients, the pill is not just easier, it is psychologically more acceptable.”
Novo Nordisk has not released a list price for the pills, which must be taken daily, but they are expected to be cheaper than weekly injections. Questions about insurance coverage remain; many private insurers limit coverage for injections due to their high cost. Medicare is prohibited by law from covering weight-loss drugs, but the pill has also been approved to reduce the risk of heart disease, which Medicare does cover.
In November Novo Nordisk reached an agreement with the Trump administration sell the lowest dose pill for $149 a month to people who pay out of pocket in exchange for tariff breaks. Lilly entered into a similar agreement for its diet pill.
Like injections, tablets can be taken in multiple doses. People usually start with the lowest dose and gradually increase it over several weeks to adjust to any side effects.
How well do Wegovy tablets work?
Results of phase 3 clinical trials published in the journal New England Journal of Medicine found that people taking the highest dose of the Wegovy tablet lost an average of 16.6% body weight after 64 weeks, compared to a 2.2% weight loss in the placebo group.
This is roughly equivalent to the injectable version of Wegovy, which has been shown in clinical trials to reduce weight by about 15% after 68 weeks.
Dr. Shawna Levy, medical director of the Tulane Weight Loss Center, said the biggest challenge for people who choose the pill option will likely be compliance: 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 study who did not adhere to a strict schedule lost less weight, an average of 13.6% of their body weight.
The question remains about “actual performance,” McGowan said. “Will patients tolerate daily dosing and strict adherence to the schedule? Will they be able to continue taking it long enough to see meaningful results? We don't know yet.”
As with GLP-1 injections, the most common side effects in the study were gastrointestinal effects, including nausea and vomiting. In some cases, side effects from the pills can be “more intense” because the medicine goes straight into the stomach and can cause nausea, McGowan said.
“The problems we see with GLP-1 injections don't magically go away with a pill,” he said.
Although the weight loss observed with Wegovy tablets was the same as with the injections, Levy said that in general, oral GLP-1 medications do not typically result in as much weight loss as the new injections.
Lilly's Zepbound helped people lose an average of 22.5% of their body weight over 72 weeks of clinical trials. And Lilly's new generation injection, retatrutide — which has not yet been approved — resulted in an average weight loss of 24% after 48 weeks.
“Zepbound maintains its status as the top treatment for obesity, second only to weight loss surgery in terms of results,” Levy said.
Novo Nordisk says the differences in weight loss may come down to which pill is swallowed. The body breaks down part of the tablet as it moves through the digestive tract, so less medication enters the bloodstream compared to an injection. To counter this, tablets have a higher dose than injections and should be taken daily rather than weekly.
Wegovy's pill is closer in effectiveness to Lilly's orforgliprone, which helped people lose about 10.5% of their body weight over 72 weeks in a late-stage study.
This is not a direct comparison because the drugs were not compared in head-to-head clinical trials.
The company expects the Wegovy tablet to become widely available in January, a Novo Nordisk spokesman said.
When Wegovy was first approved, it faced a long-running shortage. To make up for the shortfall this time, the company has increased production of the tablets in preparation for its launch, the spokesperson said.
McGowan said oral medications are often easier to produce than injectables, which could help avoid shortages.
