Lilly Secures FDA Approval For Foundayo With Strong Trial Results, Expanding Oral Treatment Options For Obesity

Eli Lilly and Company has received approval from the U.S. Food and Drug Administration for Foundayo™ (orforglipron), a new oral treatment for adults with obesity or overweight individuals with related health conditions. The drug is designed to support weight loss and maintenance when combined with diet and exercise, and will be available through LillyDirect® and retail channels starting April 2026.

"People living with obesity need treatment options that meet them where they are – and for many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment," said Deborah Horn, DO, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston. "With Foundayo, we now have an oral option that delivered an average of 12.4% weight loss at the highest dose in clinical trials – addressing both the clinical realities of obesity and the practical challenges patients face every day."

The approval is based on results from the ATTAIN clinical trial program, which demonstrated significant weight loss benefits. In the ATTAIN-1 study, patients on the highest dose lost an average of 27.3 pounds compared to minimal weight loss with placebo. Across trials, the treatment also showed improvements in cardiovascular risk markers, including cholesterol levels, triglycerides, blood pressure, and waist circumference.

"Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity or the belief that their condition isn't serious enough for treatment. We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications," said David A. Ricks, chair and CEO of Eli Lilly and Company. "As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world."

Lilly emphasized its focus on affordability and access, offering pricing options including savings programs for commercially insured patients and lower-cost options for self-pay and Medicare beneficiaries. The company aims to expand access globally, with regulatory submissions already underway in more than 40 countries.

"There is no single path that works for everyone living with overweight or obesity," said Joe Nadglowski, president and CEO of the Obesity Action Coalition. "New treatment options expand choice and help more people find care that fits their lives, their goals and where they are in their journey – whether they're just starting to explore treatment or looking for a different long-term approach."

While Foundayo provides a new oral alternative in the weight management space, it is not recommended for use with other GLP-1 therapies and carries safety considerations, including potential thyroid-related risks and common gastrointestinal side effects. The approval marks a significant step in expanding treatment options for obesity and related conditions.