FDA Approves New Weight Loss Pill But Seeks More Safety Data

Eli Lilly's Foundayo drug gets green light, but agency wants long-term studies on potential heart, liver and other risks.

Apr. 15, 2026 at 7:00pm

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A highly detailed, translucent X-ray photograph revealing the internal structures of the human digestive system, conceptually illustrating the FDA's need for more data on the potential side effects of a new weight loss drug.The FDA's request for additional long-term safety studies on Eli Lilly's new weight loss drug Foundayo reflects ongoing concerns about the potential risks of obesity medications.Cary Today

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly's new obesity drug Foundayo, but is requiring the company to conduct additional long-term studies on potential serious side effects such as heart attack, stroke, liver injury, and thyroid cancer. The agency says current data is not sufficient to fully understand all the risks associated with the drug's newer active ingredient, orforglipron.

Why it matters

The approval of Foundayo provides people with an alternative oral treatment option to injectable weight loss drugs. However, the FDA's request for more safety data highlights the agency's cautious approach to approving new obesity medications, given the potential for serious side effects that have been associated with some past weight loss drugs.

The details

Foundayo was approved through an FDA pilot program designed to speed up drug reviews. It is the second oral GLP-1 drug available, providing an alternative to injectable treatments. But the FDA said current data isn't enough to fully understand some of the potential risks. The agency has asked Eli Lilly to study serious conditions such as heart attack, stroke, drug-related liver injury, delayed stomach emptying, and a possible link to thyroid cancer. The FDA is also requiring long-term research on these safety issues, asking the company to track patients for at least 15 years.

  • Foundayo was approved earlier this month.
  • The FDA released the approval letter on Tuesday, April 15, 2026.

The players

Eli Lilly

A pharmaceutical company that developed the new obesity drug Foundayo.

U.S. Food and Drug Administration (FDA)

The federal agency that approved Foundayo but is requiring Eli Lilly to conduct additional long-term safety studies.

Dr. Christopher McGowan

A gastroenterologist who runs a weight loss clinic in Cary, North Carolina, and commented on the FDA's request for more safety data.

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What they’re saying

“With orforglipron, it's a newer, non-peptide version of a GLP-1, so we don't yet have the same depth of safety data as the injectables.”

— Dr. Christopher McGowan, Gastroenterologist

“Patient safety is Lilly's top priority and we actively monitor, evaluate and report safety information for all our medicines.”

— Eli Lilly spokesperson

What’s next

The FDA is requiring Eli Lilly to conduct additional long-term studies on the potential risks associated with Foundayo, including monitoring patients for at least 15 years for any link to thyroid cancer. The company will also need to establish registries to track outcomes in children with obesity who use weight loss drugs and pregnant patients.

The takeaway

The approval of Foundayo represents progress in providing new oral treatment options for obesity, but the FDA's cautious approach in requiring extensive additional safety studies highlights the agency's ongoing concerns about the potential risks of weight loss medications and the need for robust long-term data to ensure patient safety.