New GLP-1 pill Foundayo enters crowded weight-loss market

Federal regulators have approved a new weight-loss pill that could expand access to one of the fastest-growing classes of medications in the U.S., intensifying competition among major drugmakers.

The Food and Drug Administration approved Eli Lilly’s GLP-1 pill, Foundayo, on April 1 for adults with obesity, those who are overweight, or individuals with weight-related health conditions. Unlike most existing GLP-1 treatments, which are typically administered by injection, the once-daily pill can be taken at any time of day without food or water restrictions.

The approval positions Foundayo as a direct competitor to blockbuster drugs such as Wegovy and Zepbound, which helped transform obesity treatment in the early 2020s. Those medications, originally developed for Type 2 diabetes, have since been widely prescribed for weight loss and related conditions.

Lilly officials say the new pill could offer both convenience and improved results. In a company-funded study, patients taking Foundayo’s active ingredient lost significantly more weight than those using a competing oral medication. The drug “outperformed” a rival on “every key endpoint we measured,” said lead investigator Dr. Julio Rosenstock in a statement.

Still, competing manufacturer Novo Nordisk pushed back, noting the comparison relied on lower-dose treatments typically used for diabetes rather than higher-dose weight-loss regimens.

Early data from Lilly shows patients on the highest dose of Foundayo lost an average of 27 pounds. However, like other GLP-1 medications, the drug comes with potential side effects. Reported issues include nausea, diarrhea, vomiting, abdominal pain, and fatigue, while more serious complications—such as pancreatitis and severe stomach problems—remain rare but possible.

Cost and insurance coverage could shape how widely the drug is used. Lilly said the highest dose of Foundayo will cost about $349 per month, while lower doses may be available for as little as $25 with commercial insurance and savings programs. Without insurance, some patients may turn to direct-to-consumer purchasing options.

“More consumers are exploring things like a cash option, bypassing insurance, shopping around to get the best price,” said Amanda Nguyen, a senior health economist at GoodRx.

Insurance coverage remains uncertain. Many private insurers restrict GLP-1 coverage to patients with diabetes, while government programs such as Medicare and Medicaid typically do not cover weight-loss drugs. Lilly said some Medicare Part D enrollees could access the drug for about $50 monthly as early as July, though federal coverage decisions are still pending.

The approval comes as demand for GLP-1 medications continues to surge, driving up healthcare costs and fueling ongoing debates among insurers, employers, and drugmakers over who should pay.

Further clinical trials are expected to explore additional uses for GLP-1 drugs, which researchers say may help treat conditions ranging from sleep apnea to heart disease.