The Food and Drug Administration has approved Foundayo, a new oral GLP-1 weight loss tablet made by Eli Lilly, making it the second GLP-1 drug approved in pill form. A tablet version of the semaglutide-based drug Wegovy received approval in January.
Foundayo is approved for adults with obesity or overweight who have at least one weight-related health condition, used alongside a reduced-calorie diet and increased physical activity. The drug is taken once daily, starting at 0.8 milligrams. The dosage can be stepped up to 2.5 mg after 30 days, then to 5.5 mg after another 30 days, with further increases possible up to a maximum of 17.2 mg depending on how a patient responds and tolerates the drug.
In the pivotal ATTAIN-1 trial, participants taking the highest dose who stayed on treatment lost an average of 27 pounds. Those given a placebo lost about 2 pounds over the same period. The approval followed two randomized, double-blind, placebo-controlled trials lasting 72 days each, both involving adults with obesity or overweight plus at least one related health condition.
Despite the approval, the FDA has instructed Eli Lilly to conduct further studies on the drug's effects on the heart, liver, and other organs. That post-market requirement is not unusual for newly approved medications, but it means the full safety picture is still developing.
Eli Lilly said Foundayo is already available through its LillyDirect platform, with prescriptions accepted and shipping underway as of April 6. Broader availability through retail pharmacies and telehealth providers is expected soon. For patients with commercial insurance, the company said the cost could be as low as $25 per month. Those paying out of pocket will pay $149 per month for the lowest dose. Medicare Part D enrollees who qualify may be able to access it for $50 per month beginning July 1.
Physicians who specialize in obesity medicine welcomed the addition. "It's a significant milestone to have another GLP-1 tablet," said Pouya Shafipour, a family and obesity medicine physician at Providence Saint John's Health Center in Santa Monica. Zhaoping Li, chief of the Division of Clinical Nutrition at UCLA Health, echoed that view. "It is great to have new tools added to our toolbox to deal with obesity," she told Healthline.
Experts noted that the convenience of a pill, which unlike injectable GLP-1 drugs requires no syringes or refrigeration and can be taken with or without food, could help more patients stick with treatment over the long term. Both physicians emphasized that Foundayo, like all weight loss medications, is intended to be used alongside diet changes and regular exercise, not as a standalone fix.
