The U.S. Food and Drug Administration on Wednesday approved Eli Lilly’s new weight-loss pill, Foundayo, providing a more flexible alternative to existing injectable treatments and a rival oral medication from Novo Nordisk.
Foundayo, known chemically as orforglipron, is the second oral GLP-1 medication to reach the U.S. market for weight management, following the recent approval of a pill version of Novo Nordisk’s Wegovy. Lilly executives highlighted the drug’s convenience, noting it can be taken at any time of day without the strict food and water restrictions required by its primary oral competitor.
“We’ve really designed this to fit into people’s lives as easily as possible,” Dr. Dan Skovronsky, Lilly’s chief scientific and product officer, said, adding that the company aims to “democratize” treatment for the millions of Americans struggling with obesity.
In clinical trials supporting the approval, patients on the highest dose of Foundayo lost an average of 12% of their body weight over 72 weeks, compared to 0.9% for those on a placebo. While this is lower than the weight loss typically seen with injectable GLP-1s like Zepbound, the pill is expected to appeal to patients with less severe obesity or those who prefer a daily tablet over a weekly injection.
The approval comes amid a significant shift in drug pricing and access. Following a deal struck with the Trump administration in November, Lilly will offer Foundayo starting at $149 a month out-of-pocket for the lowest doses. High-dose monthly costs will reach $399, though many commercially insured patients may pay as little as $25 through company coupons. Medicare is expected to begin covering the pill for eligible patients in July.
Common side effects include nausea and constipation, with some patients also experiencing hair loss. Lilly cautioned that the drug may interfere with the efficacy of birth control pills.
Foundayo is scheduled for release on April 6 through the LillyDirect home-shipping platform.