Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved Foundayo (orforglipron) for adults with obesity or overweight with weight-related medical problems.
This marks the second GLP-1 approved by the regulator to treat obesity, after Novo Nordisk's Wegovy pill was approved in December 2025.
The agency's decision to approve Foundayo took only 50 days — the fastest for a brand-new kind of drug since 2002.
Lilly said in its statement that Foundayo will be available via its online service LillyDirect, with prescriptions accepted immediately and shipping beginning April 6, followed "shortly after" by broad availability through US retail pharmacies and telehealth providers.
"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.
"Today, fewer than one in ten 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," said David A. Ricks, chair and CEO of Eli Lilly and Company.
"We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications."
As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world.
Supported by the rigorous ATTAIN clinical trial programme, Foundayo has been shown to help individuals lose weight and maintain their weight loss.
In the ATTAIN-1 trial, participants who received the highest dose of Foundayo and completed treatment lost an average of 27.3 pounds (12.4%), compared with only 2.2 pounds (0.9%) with placebo.
Participants taking Foundayo, regardless of whether they completed the trial, lost an average of 25 pounds (11.1%), while those on the placebo lost only 5.3 pounds (2.1%).
Additionally, the ATTAIN programme demonstrated that Foundayo contributed to significant reductions in various cardiovascular risk factors, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure across all doses.
Rival pharma company Novo Nordisk has hit back at Lilly, with Jamey Millar, Executive Vice President for US operations, saying: "Not all GLP-1s are the same."
Any reports claiming orforglipron is more effective than Wegovy pill for weight management are inaccurate and misleading.
"There is no head-to-head trial comparing the efficacy of orforglipron and Wegovy pill and Wegovy pill has demonstrated a magnitude of weight loss no other oral GLP-1 obesity candidate by itself, as a singular molecule, has shown in a Phase III study without the benefit of another agent."
Lilly has submitted orforglipron for weight management and/or type 2 diabetes in more than 40 countries and plans to launch in each country shortly after approval.