Another GLP-1 weight loss pill gets FDA approval, and it has fewer restrictions on how it’s used
Eli Lilly’s Foundayo, an orforglipron GLP-1 pill for weight loss, won FDA approval and enters the market with fewer restrictions on timing, food and water than rival oral options.
Eli Lilly’s Foundayo won FDA approval as a GLP-1 weight loss pill that can be taken without food and water restrictions, expanding obesity treatment options.
Key facts
- The FDA approved Foundayo, Eli Lilly’s GLP-1 pill for weight loss.
- The medicine is made by Lilly, which also sells Zepbound for obesity and Mounjaro for diabetes.
- Unlike the Wegovy pill, Foundayo can be taken at any time of day and without restrictions on food and water.
- The drug was approved for people with obesity or who are overweight with weight-related medical problems.
Eli Lilly's GLP-1 pill, Foundayo, received FDA approval on Wednesday. The U.S. Food and Drug Administration approved the second GLP-1 pill for weight loss, adding another option to a rapidly growing arsenal of obesity therapies. The orforglipron pill, called Foundayo, is made by Eli Lilly, which also sells the GLP-1 drugs Zepbound for obesity and Mounjaro for diabetes.
Those medicines are given as weekly injections and, along with rival drugs Wegovy and Ozempic, have transformed weight-loss and diabetes treatment, with millions of people taking the medicines. Foundayo is coming to market just months after the FDA approved the pill form of Novo Nordisk’s injectable obesity drug Wegovy.
Both pills offer a new way to take GLP-1 medicines, so named for the hormone they mimic that’s important for appetite, digestion and insulin regulation. But Lilly says Foundayo represents an advance because, unlike the Wegovy pill, it can be taken at any time of day and without restrictions on food and water.
“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.
Foundayo enters a fast-growing GLP-1 obesity treatment market
The Wegovy pill must be taken first thing in the morning, 30 minutes before food or drink, which can interfere with its absorption. That restriction has not appeared to affect its popularity, however. It is already being used by as many as 400,000 people in the United States, according to estimates cited from Wall Street firm Mizuho.
The pills also represent a major change in pricing and access to GLP-1 drugs. In a deal struck with the Trump administration in November, the pills start at $149 a month at the lowest doses for patients paying out of pocket, a much lower price than had previously been available. This pricing shift has added to expectations that oral GLP-1 medicines could broaden the obesity treatment market.
Lilly positions Foundayo as a more flexible oral GLP-1 option
Lilly’s medicine will cost as much as $349 out of pocket for the highest doses, still a hefty monthly sum for a medicine designed to be taken long term. Lilly said that if patients refill their prescription within a 45-day window, the highest out-of-pocket price would be $299 a month.
Patients whose insurance covers the medicines will probably have much lower copays, and Lilly said it will offer a coupon for people with commercial insurance so they may pay $25 a month. As part of the Trump administration deal, Lilly said Medicare would also cover the pill for some patients, with a monthly copay of no more than $50, starting as soon as July 1.
“We really want to democratize treatment of obesity and overweight for the millions of Americans that need it,” Skovronsky said. He noted that Lilly estimates that fewer than 1 in 10 people who could benefit from a weight-loss medicine are taking one of the injectable drugs, and said the pills might appeal to people who have less severe obesity and have not wanted to try a weekly shot.
Who can use Lilly’s new GLP-1 pill for weight loss
Similar to the other GLP-1 weight loss drugs, Foundayo was approved for people with obesity or who are overweight and have weight-related medical problems, such as high blood pressure. That means the pill is positioned as another treatment option for a broad patient population already familiar with GLP-1 medicines, but who may prefer tablets over injections.
The approval of Foundayo therefore adds a significant new oral alternative in one of the pharmaceutical industry’s most competitive and fastest-growing therapy areas. For Lilly, the launch strengthens its obesity franchise beyond injectable drugs, while for patients it may offer a more convenient way to use GLP-1 therapy without the timing, food and water restrictions that come with some competing oral treatments.
