The FDA approved Eli Lilly’s once-daily orforglipron GLP-1 pill (brand name Foundayo) for weight management in adults. 

The indication is “for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition,” according to an FDA statement. 

Orforglipron is the first small molecule (nonpeptide) for obesity, meaning that it — unlike the current semaglutide (Wegovy) pill — can be taken any time of day without food or water restrictions. It will be available in oral tablets of 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg.

The approval was based on results from Lilly’s ATTAIN clinical trial program in people with obesity/overweight, with and without type 2 diabetes. In ATTAIN-1, those taking the highest dose who stayed on the drug for the entire 72-week trial lost an average of 27.3 pounds (12.4%) compared to 2.2 pounds (0.9%) with placebo. Regardless of trial completion, participants lost an average of 25 pounds (11.1%) vs just 5.3 pounds (2.1%) with placebo. 

Across the ATTAIN trials and for all doses, orforglipron also was associated with reductions in cardiovascular risk markers, including waist circumference, non-HDL cholesterol, triglycerides, and systolic blood pressure.

As with other GLP-1 drugs, orforglipron is associated with gastrointestinal adverse events including nausea, constipation, vomiting, dyspepsia, and abdominal pain, as well as headache, fatigue, and hair loss. The label will contain warnings and precautions about pancreatitis, severe gastrointestinal reactions, acute kidney injury due to volume depletion, hypoglycemia, and diabetic retinopathy in those with diabetes, among others. It will also carry a boxed warning for thyroid C-cell tumors. 

Orforglipron is the first “new molecular entity” and the fifth drug overall to be approved under the FDA’s Commissioner’s National Priority Voucher pilot program, which aims to “expedite approval of applications that address critical national health priorities,” according to the FDA. The approval came 50 days after Lilly’s filing, 294 days before the anticipated date of January 20, 2027. 

Prescriptions are now being accepted via the company’s LillyDirect program, with shipping to begin April 6, followed shortly by broad availability through US retail pharmacies and telehealth providers. Eligible people with commercial insurance can pay as little as $25/month with a savings card, while self-pay costs start at $149/month for the lowest dose. Eligible individuals with Medicare Part D “may be able to get Foundayo for $50 per month, beginning as soon as July 1, 2026,” Lilly said. 

Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker and BlueSky @miriametucker.bsky.social