FDA Approves Eli Lilly Weight Loss Pill Foundayo in Fastest Drug Review Since 2002

The oral GLP-1 medication can be taken any time of day, no food restrictions required, and starts shipping Monday.

The U.S. Food and Drug Administration on Wednesday approved Eli Lilly's new daily weight loss pill, Foundayo, making it the second oral GLP-1 medication cleared for obesity treatment in the United States and setting up a direct showdown with Novo Nordisk's Wegovy pill.

Screenshot of Foundayo.lilly.com

The approval covers orforglipron, the active ingredient in Foundayo, which Lilly also sells in injectable form as Zepbound for obesity and Mounjaro for diabetes.

The FDA cleared Foundayo in just 50 days under the Commissioner's National Priority Voucher pilot program, the fastest approval of a new molecular entity since 2002.

Standard reviews typically take six to ten months.

"This approval demonstrates what the FDA can achieve when we eliminate delays and prioritize fast and thorough work from the agency and industry partners," FDA Commissioner Martin Makary said in a statement.

Unlike the Wegovy pill, which must be taken on an empty stomach each morning, Foundayo can be taken at any time of day without food or water restrictions.

Lilly acquired the molecule from Japanese drugmaker Chugai in 2018, paying just $50 million up front for global rights.

The company has since invested more than $55 billion in manufacturing since 2020 to support production as Lilly developed a new ingredient, orforglipron, that is not a peptide like the injectable drugs but acts like one, making it easier for the body to absorb in pill form.

Foundayo will be offered in six doses. Patients typically start at the lowest dose and work their way up to reduce side effects.

The most commonly reported side effects include nausea, constipation, diarrhea, and hair loss, consistent with other GLP-1 medications.

In a clinical trial of more than 3,000 adults with obesity, participants who received the highest dose of orforglipron lost 11.2% of their body weight, roughly 25 pounds on average, over more than 16 months.

That compared with a 2.1% weight loss in patients who received a placebo, according to the New England Journal of Medicine.

Those results are similar to the Wegovy pill but less than injectable versions of Wegovy and Zepbound.

Beyond weight loss, Lilly said Foundayo also reduced several markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure across all doses.

Pricing and Access

People with insurance coverage could pay $25 a month with a coupon from Lilly, while people paying out of pocket could pay between $149 and $349, depending on the dose.

Under the Trump administration deal, Medicare will cover the pill for some patients with a monthly copay of no more than $50, starting as soon as July 1.

Lilly said the drug will be available for free home shipping via its LillyDirect platform starting April 6, with broader availability via pharmacies and telehealth providers shortly after.

Lilly expects approval for Foundayo in more than 40 countries over the next year. Novo Nordisk, meanwhile, reported more than 600,000 prescriptions for its Wegovy pill in March, with early data suggesting the oral market is drawing in new patients rather than converting users from injections.

Lilly's chief scientific officer, Daniel Skovronsky, said he expects Foundayo to appeal primarily to patients who consider injections too big a step.

"I think ideally this medicine will be for people who haven't tried a weight loss drug yet," he said.