FDA Approves Eli Lilly’s GLP-1 Pill

The US Food and Drug Administration on Wednesday approved a new obesity pill called Foundayo. Taken once daily, the pill is made by pharmaceutical company Eli Lilly, which also manufactures the popular weight-loss injection Zepbound.

Foundayo is a type of medication known as a GLP-1, a category that includes rivals Ozempic and Wegovy. These drugs mimic a naturally occurring hormone in the body that regulates blood sugar, slows digestion, and signals a sense of fullness to the brain.

It’s now the second GLP-1 pill for weight loss on the market. In December, Novo Nordisk received FDA approval for its pill form of Wegovy. The company’s original version of Wegovy is a weekly injectable. While the Wegovy pill must be taken on an empty stomach in the morning, Lilly says Foundayo can be taken any time of day without food or water restrictions.

With injectable GLP-1 drugs in high demand, pharma companies have been racing to develop weight-loss pills, which could be preferable for some patients and could potentially expand the market for GLP-1s. Pills are also easier to manufacture than injectable medications, which could help maintain continual access for patients. GLP-1 medications were in severe shortage from late 2022 through early 2025 because demand outstripped manufacturing capacity.

“Beyond supply and affordability, one of the bigger barriers to adoption has been that some patients just don’t want to take an injection,” says Ken Custer, executive vice president of Eli Lilly. “That could be because it’s a needle, but it also may just be that for them, an injection signifies that their condition is more severe than they feel it is at that point. For patients looking to get started with their weight management journey, maybe a pill is an easier place for them to start.”

Like injectable GLP-1s, Foundayo starts at a low dose and is gradually increased to minimize nausea, vomiting, and diarrhea that can come with these drugs.

In a clinical trial, individuals taking the highest dose of Foundayo over 18 months lost an average of 27 pounds, or 12.4 percent of their body weight over 18 months. Those taking a placebo lost just 2 pounds, or less than 1 percent of their body weight, over the same time. Lilly’s tirzepatide, the active ingredient in its injectables Mounjaro and Zepbound, has shown a more than 20 percent reduction in weight.

For Novo Nordisk’s Wegovy pill, study participants achieved an average weight loss of 13.6 percent by 16 months. There have been no head-to-head trials comparing the efficacy of Foundayo and the Wegovy pill.

Eli Lilly did run a study to find out what happens when people switch from an injectable GLP-1 drug to Foundayo and found that it helped people maintain most of their weight loss. Those who switched to the pill from injectable Wegovy regained an average difference of 2 pounds, while those who switched to Foundayo from Zepbound gained an average of 11 pounds. The active ingredient in Foundayo, orforglipron, is also being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, and other conditions.

Foundayo is now available via the direct-to-consumer platform LillyDirect, with shipping beginning April 6. Eli Lilly says Foundayo will be available more broadly across US retail pharmacies and telehealth providers shortly after that. The pill was included in a November 2025 deal to be offered through the TrumpRx platform.

In its announcement on Wednesday, the FDA said it reviewed Foundayo in just 50 days as part of a new pilot program intended to expedite approvals for drugs that align with national health priorities. New drug approvals typically take six to 10 months.