FDA approves Foundayo, Lilly’s once-daily oral GLP-1 pill for weight loss
The Food and Drug Administration this week approved Foundayo, a once-daily oral medication from Eli Lilly for adults with obesity or adults who are overweight with weight-related medical conditions, marking a notable shift in how GLP-1 therapies can be delivered.
Foundayo is now the second GLP-1 therapy approved for obesity in pill form, in addition to the Wegovy pill. Until a few months ago, the most effective weight-loss drugs—such as tirzepatide (Zepbound) and semaglutide (Wegovy)—were available only as injections. The active ingredient in Foundayo, orforglipron, is a GLP-1 receptor agonist, the same class as Ozempic and Wegovy.
These drugs help drive weight loss by slowing stomach emptying, increasing satiety, and acting on appetite centers in the brain to reduce cravings. Although both approved oral options act on the GLP-1 pathway, they differ in how they are taken. The Wegovy pill is a modified protein that must be taken on an empty stomach and requires a 30-minute fasting period afterward to avoid the stomach’s acidic environment.
Foundayo is a small molecule stable in the stomach and can be taken at any time of day, with or without food—an advantage that may improve adherence for patients who prefer pills over injections. In Eli Lilly’s latest clinical trials, participants assigned to the highest dose of Foundayo for 72 weeks lost an average of 12.4% of their body weight.
That is less than typical reductions reported with injectable Zepbound or Wegovy, which have shown weight loss of about 15% to 21% of body weight. No clinical trial to date has compared weight loss between the oral Wegovy formulation and Foundayo head-to-head.
According to Eli Lilly, trial participants taking Foundayo also saw reductions in non-HDL cholesterol, triglycerides, and systolic blood pressure across all doses. Side effects for Foundayo are similar to other GLP-1 agonists. The most common are gastrointestinal symptoms such as nausea, vomiting, constipation, and diarrhea.
More rarely, pancreatitis has been reported. Other less common risks include inflammation of the gallbladder, kidney injury, and a risk of a specific type of thyroid cancer. List prices for those paying out of pocket are expected to range from about $149 to $349 per month, depending on dose, according to the information provided.
With commercial or private insurance, some patients could pay as little as $25 per month. Medicare Part D recipients may be able to access the drug for $50 per month beginning as soon as July 1, 2026. These amounts are below the list prices of some injectable weight-loss medications, which can exceed $1,000 a month.
Coverage will vary by insurer, and some plans may require prior authorization. The approval broadens options for patients who have avoided injections, but real-world uptake will depend on insurance coverage and affordability. With more oral GLP-1 choices moving into the market, questions of access and comparative effectiveness are likely to shape how physicians and patients navigate obesity treatment in the months ahead.