The US Meals and Drug Administration on Wednesday authorised a brand new weight problems capsule known as Foundayo. Taken as soon as each day, the capsule is made by pharmaceutical firm Eli Lilly, which additionally manufactures the favored weight-loss injection Zepbound.
Foundayo is a kind of medicine referred to as a GLP-1, a class that features rivals Ozempic and Wegovy. These medicine mimic a naturally occurring hormone within the physique that regulates blood sugar, slows digestion, and alerts a way of fullness to the mind.
It’s now the second GLP-1 capsule for weight reduction in the marketplace. In December, Novo Nordisk obtained FDA approval for its capsule type of Wegovy. The corporate’s unique model of Wegovy is a weekly injectable. Whereas the Wegovy capsule should be taken on an empty abdomen within the morning, Lilly says Foundayo might be taken any time of day with out meals or water restrictions.
With injectable GLP-1 medicine in excessive demand, pharma corporations have been racing to develop weight-loss tablets, which may very well be preferable for some sufferers and will probably develop the marketplace for GLP-1s. Capsules are additionally simpler to fabricate than injectable medicines, which may assist keep continuous entry for sufferers. GLP-1 medicines had been in extreme scarcity from late 2022 by way of early 2025 as a result of demand outstripped manufacturing capability.
“Past provide and affordability, one of many greater obstacles to adoption has been that some sufferers simply do not need to take an injection,” says Ken Custer, govt vice chairman of Eli Lilly. “That may very well be as a result of it is a needle, however it additionally could be that for them, an injection signifies that their situation is extra extreme than they really feel it’s at that time. For sufferers trying to get began with their weight administration journey, possibly a capsule is a better place for them to begin.”
Like injectable GLP-1s, Foundayo begins at a low dose and is steadily elevated to attenuate nausea, vomiting, and diarrhea that may include these medicine.
In a scientific trial, people taking the very best dose of Foundayo over 18 months misplaced a mean of 27 kilos, or 12.4 % of their physique weight over 18 months. These taking a placebo misplaced simply 2 kilos, or lower than 1 % of their physique weight, over the identical time. Lilly’s tirzepatide, the energetic ingredient in its injectables Mounjaro and Zepbound, has proven a greater than 20 % discount in weight.
For Novo Nordisk’s Wegovy capsule, research members achieved a mean weight lack of 13.6 % by 16 months. There have been no head-to-head trials evaluating the efficacy of Foundayo and the Wegovy capsule.
Eli Lilly did run a research to search out out what occurs when folks change from an injectable GLP-1 drug to Foundayo and located that it helped folks keep most of their weight reduction. Those that switched to the capsule from injectable Wegovy regained a mean distinction of two kilos, whereas those that switched to Foundayo from Zepbound gained a mean of 11 kilos. The energetic ingredient in Foundayo, orforglipron, can be being studied as a possible therapy for kind 2 diabetes, obstructive sleep apnea, osteoarthritis knee ache, and different circumstances.
Foundayo is now accessible by way of the direct-to-consumer platform LillyDirect, with transport starting April 6. Eli Lilly says Foundayo can be accessible extra broadly throughout US retail pharmacies and telehealth suppliers shortly after that. The capsule was included in a November 2025 deal to be supplied by way of the TrumpRx platform.
In its announcement on Wednesday, the FDA mentioned it reviewed Foundayo in simply 50 days as a part of a brand new pilot program supposed to expedite approvals for medicine that align with nationwide well being priorities. New drug approvals usually take six to 10 months.
