FDA asks drugmaker Eli Lilly for more safety information on its new GLP-1 weight loss pill

A GLP-1 weight loss pill, already on sale in the United States, has hit a regulatory snag.

The Food and Drug Administration has asked U.S. drugmaker Eli Lilly to collect more long-term safety data on its once-daily tablet Foundayo, according to an 1 April letter published by the FDA Tuesday.

The FDA approved the pill under its programme to fast-track drugs using 72-week, Phase 3 trial data but still needs to look at years-long data to understand all of the potential risks.

At the heart of the request is whether taking Foundayo - made using a new active ingredient called orforglipron - could be linked to liver, heart and gastrointestinal problems.

“We have determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess a signal of a serious risk of retained gastric contents and to identify an unexpected serious risk for major adverse cardiovascular events, drug-induced liver injury and exposure to [Foundayo] during lactation,” the FDA wrote.

Eli Lilly has until the end of April to complete that clinical trial and until July to submit a final report.

An Eli Lilly spokesperson told The Independent that “patient safety is Lilly’s top priority” and that the company actively monitors, evaluates and reports safety information for all its medicines.

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Source: The Independent, 16 April 2026