The U.S. Food and Drug Administration (FDA) has approved a new GLP-1 weight-loss pill from drugmaker Eli Lilly, the agency said on Wednesday.
The drug – Foundayo – is the second oral GLP-1 pill approved for sale in the U.S. after the agency approved Novo Nordisk’s Wegovy pill in December 2025.
The once-a-day oral pill was approved for “adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight,” Eli Lilly said.
It is not yet clear whether the drug is safe for children.
Foundayo must be taken “alongside a reduced-calorie diet and increased physical activity,” the company added.
The FDA said the drug was approved within 50 days of the company filing for approval, one of the fastest approval times for any drug.
“This approval demonstrates what the FDA can achieve when we eliminate delays and prioritize fast and thorough work from the agency and industry partners,” FDA commissioner Martin Makary said in a statement.
During the trial, individuals taking the highest dose of Foundayo and who stayed on treatment lost an average of 27.3 pounds (12.3 kilograms), compared with 2.2 pounds (0.9 kg) with placebo, the company said.
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Starting dosage is 0.8 milligrams, which should be increased to 2.5 mg after at least 30 days and then to 5.5 mg after another 30 days, the FDA said.
The dosage may be increased further to nine mg, 14.5 mg or 17.2 mg after at least 30 days at each level based on treatment response and tolerability, it added.
For uninsured people, the drug will cost US$149 a month, Eli Lilly said.
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas and hair loss, the company said.
“Foundayo may cause tumors in the thyroid, including thyroid cancer,” it added.
A 2023 study out of the University of British Columbia found that GLP-1 drugs were associated with an increased risk of stomach paralysis, pancreatitis and bowel obstruction.
In 2024, a Harvard study found that the drugs were also linked to an increased risk of sudden and irreversible vision loss and blindness.
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