Eli Lilly has announced that the U.S. Food and Drug Administration (FDA) has approved Foundayo (orforglipron) for adults with obesity, or those who are overweight with weight-related health issues. When combined with a reduced-calorie diet and increased physical activity, Foundayo helps people lose excess weight and maintain the loss.

Foundayo will initially be available through LillyDirect, with prescriptions accepted immediately and shipments starting April 6. Broader availability through U.S. retail pharmacies and telehealth providers will follow shortly.

“People with obesity need treatment options that fit into their lives,” said Deborah Horn, DO, director of the Center for Obesity Medicine at McGovern Medical School, UTHealth Houston. “For many, a once-daily oral pill with no food or water restrictions provides flexibility. Clinical trials showed an average weight loss of 12.4% at the highest dose, addressing both the medical and practical challenges of obesity.”

David A. Ricks, chair and CEO of Eli Lilly and Company, added: “Currently, fewer than 1 in 10 people who could benefit from a GLP-1 therapy are using one due to barriers like access, stigma, perceived complexity, or the belief their condition isn’t serious. Foundayo can help make effective treatment more accessible, offering meaningful weight loss in a convenient daily pill.”

The company has submitted orforglipron for weight management and/or type 2 diabetes approval in over 40 countries, with plans to launch shortly after each approval.