The U.S. Food and Drug Administration (FDA) has approved the first GLP-1 pill to reduce excess body weight, introducing a needle-free way to get the same active ingredient in the injectable GLP-1 drugs Ozempic and Wegovy.
[1]
The once-daily Wegovy pill (semaglutide) was approved for weight loss and weight maintenance in adults who are overweight or have obesity and at least one related health problem, drugmaker Novo Nordisk said in a statement.
It was also approved to reduce the risk of heart attack, stroke, and death in people who have heart disease and are overweight or have obesity, the company said.
Studies have shown that the Wegovy pill is roughly as effective as its injectable counterpart.
Novo Nordisk expects the starting 1.5 milligram (mg) dose of Wegovy pill to be available in early January, at a cost of $149 per month. The company didn’t announce prices for higher doses.
[2]
A semaglutide pill called Rybelsus has been available for many years, but the FDA only approved it to treat diabetes, and the maximum dose is 14 mg.
Weight Loss in Clinical Trials
The FDA approved the Wegovy pill based on results from the OASIS 4 phase 3 clinical trial, a 64-week study that enrolled 307 adults who were overweight or had obesity and one or more weight-related health issues, but not diabetes.
[3]
Researchers randomly assigned participants to take a daily pill containing 25 mg of semaglutide or a placebo. After 64 weeks, people on the Wegovy pill lost an average of 13.6 percent of their starting body weight, compared with 2.2 percent for the placebo.
The study also found:
- Almost 8 in 10 people on the Wegovy pill lost at least 5 percent of their starting weight, compared with about 3 in 10 taking a placebo pill.
- Half lost at least 15 percent of their starting weight, compared with 5.6 percent taking the placebo.
- Roughly 30 percent lost at least 20 percent of their starting weight, compared with 3.3 percent taking the placebo.
This proportion of “super responders” — people that lose at least 20 percent of their starting weight — is similar to what’s seen when people take injected GLP-1 medications, says Jody Dushay, MD, an endocrinologist at Beth Israel Deaconess Medical Center and an assistant professor at Harvard Medical School in Boston.
“These results are impressive and exciting,” Dr. Dushay says.
What Are the Side Effects of the Wegovy Pill?
Most participants taking the 25 mg Wegovy pill did experience side effects, which were typically mild. Overall, 74 percent of people on the drug reported stomach issues like nausea and vomiting. Side effects led almost 7 percent of people on oral semaglutide to discontinue treatment.
These side effects are similar to injectable Wegovy and Ozempic, says Melanie Jay, MD, a professor of medicine and population health at the New York University Grossman School of Medicine and director of the NYU Langone Comprehensive Program on Obesity Research.
“Oral and injectable semaglutide have broadly comparable gastrointestinal risk, high rates of mostly mild gastrointestinal symptoms, and low rates of serious events,” Dr. Jay says.
Oral Semaglutide Has Pros and Cons
The Wegovy pill comes with some restrictions around when and how to take it.
“It’s important to know that oral semaglutide has to be taken on an empty stomach with a small amount of water, at least 30 minutes before any food, drink, or other medications to maximize absorption,” Dushay says.
However, the pill may appeal to people who don’t want to use needles, Jay says. Injectable GLP-1 drugs also must be stored in the fridge, which may put off some people who find this reduces privacy and convenience, compared with taking a pill.
However, as with injectable GLP-1s, cost may be a consideration in determining access to the Wegovy pill, particularly since many insurance plans don’t cover obesity medications, Dushay says. “Unfortunately, I think insurance will still primarily determine how people choose which medication to take for weight loss,” Dushay says.
Another GLP-1 Pill May Soon Be Available
The Wegovy pill is not the only GLP-1 oral treatment expected in 2026.
Drugmaker Eli Lilly is seeking FDA approval for its own GLP-1 pill, orforglipron, with a decision anticipated early next year. Unlike Wegovy, orforglipron has fewer restrictions around timing.
