Federal health authorities gave the green light Wednesday to a new daily weight-loss medication from Eli Lilly, marking the second oral drug available for treating obesity and related health conditions.
The Food and Drug Administration fast-tracked approval for orforglipron, a GLP-1 medication that functions similarly to popular injection treatments by copying a natural hormone that regulates hunger and satiety.
The medication will be sold under the brand name Foundayo and is scheduled to reach pharmacies on Monday. Eli Lilly announced that insured patients could access the drug for as little as $25 monthly using the company’s discount program. Those paying out-of-pocket will face costs ranging from $149 to $349 per month based on dosage strength.
This oral option joins Novo Nordisk’s pill version of Wegovy, which has generated over 600,000 prescriptions across the United States since receiving approval in December.
The FDA cleared Eli Lilly’s medication through a new initiative designed to accelerate drug approval timelines. Officials completed their review of the company’s submission in just 50 days.
During clinical testing involving more than 3,000 obese adults, those receiving the maximum 36-milligram dose of orforglipron shed 11.2% of their body weight — approximately 25 pounds on average — over a period exceeding 16 months. In contrast, participants given a placebo lost only 2.1% of their weight, or fewer than 5 pounds, according to findings published in the New England Journal of Medicine.
Neither oral medication from Lilly nor Novo Nordisk achieved the weight reduction seen with injectable versions. Lilly’s Zepbound injections produce an average 21% weight loss, while Novo Nordisk’s injectable Wegovy averages around 15%.
While both once-daily pills offer ease of use, orforglipron provides greater flexibility as a small-molecule GLP-1 drug with no dietary restrictions. The Wegovy pill requires specific timing — taken with minimal water on an empty stomach in the morning, followed by a 30-minute wait before consuming food or beverages.
Study participants taking orforglipron also experienced better waist measurements, blood pressure readings, triglyceride levels, and cholesterol numbers, researchers reported.
Digestive problems and other side effects caused 5% to 10% of orforglipron users to stop treatment, compared to nearly 3% in the placebo group.
Research from KFF, a nonprofit health policy organization, shows roughly one in eight Americans have tried injectable GLP-1 medications. However, many more struggle to afford the expensive shots.
The Indianapolis-based Lilly’s new pill will be part of a Trump administration agreement to reduce costs for GLP-1 drugs.
