New Weight Loss Pill, Foundayo, Gets Approval But FDA Seeks More Safety Data

Follow Drugslib on

By HealthDay Staff HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on April 15, 2026.

via HealthDay

WEDNESDAY, April 15, 2026 — The U.S. Food and Drug Administration (FDA) has told Eli Lilly to study possible heart, liver and other risks tied to its new obesity drug Foundayo, according to an approval letter released Tuesday.

Foundayo was approved earlier this month through an FDA pilot program designed to speed up drug reviews.

It is the second oral GLP-1 drugs available, providing people with 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 the company to study serious conditions such as heart attack, stroke and drug-related liver injury.

It also wants more information on delayed stomach emptying, a condition in which food stays in the stomach too long, NBC News reported.

What's more, the FDA is requiring long-term research on a possible link to thyroid cancer.

Injectable versions of these drugs already carry a boxed warning for this risk, and the agency wants Lilly to track patients for at least 15 years, NBC News said.

Foundayo uses a newer active ingredient, called orforglipron, which lacks the same level of long-term safety data as older drugs.

The FDA did not request similar additional studies when the oral version of Wegovy was approved. It contains semaglutide, which has been studied since 2017.

“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, a gastroenterologist who runs a weight loss clinic in Cary, North Carolina, told NBC News.

“It doesn’t mean a safety problem has been found," he said. "It means they want more definitive long-term data.”

The FDA is also asking for additional studies, including a registry to track children with obesity who use weight loss drugs and another to monitor outcomes in pregnant patients.

A spokesperson for Eli Lilly said these post-approval requirements are routine.

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

Sources

  • NBC News, April 14, 2026

    • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2026-04-16 02:10

    Read more

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Popular Keywords