On Wednesday, the U.S. Food and Drug Administration granted approval for a new obesity pill, known as Foundayo, produced by Eli Lilly. This medication, which is administered once daily, complements the company's existing weight-loss injection, Zepbound.
Foundayo is classified as a GLP-1 medication, a category that encompasses competitors such as Ozempic and Wegovy. These drugs emulate a hormone that naturally occurs in the body, which plays a crucial role in regulating blood sugar levels, slowing down digestion, and signaling feelings of fullness to the brain.
With this approval, Foundayo becomes the second GLP-1 pill approved for weight loss, following Novo Nordisk's endorsement of its Wegovy pill in December. Notably, the original version of Wegovy is available only as a weekly injection, while Eli Lilly has indicated that Foundayo can be taken at any time of the day without the necessity for food or water restrictions.
As demand for injectable GLP-1 treatments continues to rise, pharmaceutical companies are actively working to develop oral alternatives that may offer greater convenience for patients and potentially broaden the market for GLP-1 medications. Oral pills present a simpler manufacturing process compared to injectables, which could help ensure consistent availability for patients. A significant shortage of GLP-1 medications was experienced from late 2022 to early 2025 due to overwhelming demand outpacing production capabilities.
Ken Custer, executive vice president of Eli Lilly, noted, “Beyond supply and affordability, one of the bigger barriers to adoption has been that some patients just don't want to take an injection. 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.”
Similar to other injectable GLP-1s, Foundayo initiates treatment at a low dose that is gradually escalated in order to minimize common side effects such as nausea, vomiting, and diarrhea.
In clinical studies, individuals who took the maximum dose of Foundayo over an 18-month period experienced an average weight loss of 27 pounds, corresponding to 12.4 percent of their body weight. In contrast, participants in the placebo group lost only two pounds, which is less than 1 percent of their body weight during the same timeframe. Eli Lilly's tirzepatide, the active ingredient in its injectable medications Mounjaro and Zepbound, has been associated with weight reductions exceeding 20 percent.
For the Wegovy pill, study participants achieved an average weight loss of 13.6 percent after 16 months. However, no direct head-to-head comparisons have been conducted to assess the effectiveness of Foundayo against the Wegovy pill.
Eli Lilly also conducted a study examining the transition from injectable GLP-1 drugs to Foundayo, and the results indicated that the pill aided in maintaining most of the participants' weight loss. Those who switched from injectable Wegovy to Foundayo regained an average of two pounds, while participants transitioning from Zepbound saw an average gain of 11 pounds.
The active ingredient in Foundayo, orforglipron, is presently being evaluated for various other conditions such as type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, and others.
Foundayo will initially be available through the direct-to-consumer platform LillyDirect, with shipping set to commence on April 6. Eli Lilly has stated that the medication will be rolled out more widely in U.S. retail pharmacies and through telehealth providers shortly thereafter. Additionally, Foundayo was included in a November 2025 agreement to be offered via the TrumpRx platform.
In its announcement, the FDA reported that it reviewed Foundayo in a remarkably short span of 50 days as part of a new pilot initiative aimed at expediting the approval process for drugs that align with national health priorities, where typical approval timelines range from 6 to 10 months.
Share this story