FDA approves GLP-1 weight loss pill Foundayo from Eli Lilly

The Food and Drug Administration approved a new diet pill from pharmaceutical maker Eli Lilly on Wednesday.

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The daily pill, called Foundayo, is the second oral GLP-1 to hit the market in recent months, following the approval of Novo Nordisk’s Wegovy pill in December.

Foundayo will be offered in six doses, with patients typically starting at the lowest dose and working their way up to reduce side effects. It can be taken at any time of the day without meal restrictions, unlike the Wegovy pill, which must be taken on an empty stomach each morning.

The lowest dose is expected to cost about $149 per month for people paying out of pocket, similar to the Wegovy pill, while higher doses could cost up to $399, according to Lilly. It’s unclear how many private insurers will cover the drug. Under a Trump administration plan, Medicare could begin covering the drug for some patients as early as this summer, with co-pays as low as $50 a month.

“It’s a major breakthrough in that it’s just an oral medication,” Dave Ricks, CEO of Eli Lilly, said in an interview. “You just put it in your pill organizer in the morning and it fits into your daily routine.”

This approval comes as the GLP-1 market continues to expand, with new options offering more weight loss, different forms or lower prices.

Lilly also has another GLP-1 drug in development, called retatrutide, which has shown greater weight loss in trials than any other drug on the market.

But pill versions tend to produce less weight loss than weekly injections – a discrepancy that could make them less attractive to patients.

Phase 3 clinical trial data found that Foundayo helped people lose 12.4% of their weight on average, at its highest dose after 72 weeks – similar to the Wegovy pill but lower than the injectable versions of Wegovy and Zepbound. These are not direct comparisons because the drugs were not compared in a comparative clinical trial.

Dr. Jody Dushay, an endocrinologist and obesity expert at Harvard Medical School, said many of his patients who switched from injections to the Wegovy pill complained of not losing as much weight.

“The jury is still out on what people are actually going to achieve with these pills,” said Dushay, who is not affiliated with either Lilly or Novo Nordisk. “I mean, 12% is low compared to what you’re going to see with Wegovy and Zepbound.”

Ricks acknowledged that Zepbound is more effective, but said pills still have their place.

“People are reporting having had a lot of success with Zepbound and then wanting to move to something, you know, something less invasive than a weekly injection, where you have to transport it in refrigerated conditions and remember to take it once a week,” he said.

Demand for diet pills is strong, if Novo Nordisk’s sales are anything to go by. In February, Novo Nordisk said more than 170,000 people were taking the Wegovy pill after its launch in January.

Dushay said the pills could be a good option for people looking to maintain their weight loss after using injectable versions.

They may also benefit patients prone to injection site reactions.

“People really have difficulty with injections,” she said.

Lilly said Foundayo’s side effects were similar to those of its injectable medications, with gastrointestinal issues – such as nausea, constipation and diarrhea – being among the most commonly reported.