Global pharma powerhouse Eli Lilly has launched once-daily weight-loss pill Foundayo (orforglipron) in the United States, following FDA approval.

 

The once-daily oral medication is approved for adults with obesity or overweight who have weight-related medical conditions. Designed to be taken without food or water restrictions, Foundayo is intended to work alongside a reduced-calorie diet and increased physical activity to support sustained weight loss.

 

The company is rolling out access immediately through LillyDirect and telehealth providers, with availability also expanding to US retail pharmacies.

 

"Foundayo delivers meaningful weight loss – an average of 27 pounds at the highest dose – and we made the path from prescription to doorstep as simple as possible," said Ilya Yuffa, executive vice president and president of Lilly USA and Global Customer Capabilities. 

 

"Millions of Americans can now connect with a health care professional to determine if Foundayo is right for them and receive the medicine at their door through LillyDirect's free home delivery, or access it through telehealth providers or local retail pharmacies."

 

Pricing starts at $149 per month for self-pay patients at the lowest dose. 

 

The approval is backed by the ATTAIN clinical trial program, which showed significant and sustained weight loss. 

 

In the ATTAIN-1 study, participants on the highest dose who completed treatment lost an average of 27.3 pounds (12.4%), compared with 2.2 pounds (0.9%) on placebo. Even across all participants, regardless of completion, those on Foundayo lost an average of 25 pounds (11.1%), versus 5.3 pounds (2.1%) in the placebo group.

 

The trials also showed improvements in key cardiovascular risk markers, including waist circumference, non-HDL cholesterol, triglycerides, and systolic blood pressure across all doses.

 

However, the treatment carries important safety considerations. Foundayo should not be used alongside other GLP-1 receptor agonists, and its safety in children has not been established. 

 

The label also warns of a potential risk of thyroid tumors, including thyroid cancer, with symptoms such as a neck lump, hoarseness, difficulty swallowing, or shortness of breath requiring immediate medical attention.