The US Meals and Drug Administration on Wednesday approved a brand new weight problems tablet known as Foundayo. Taken as soon as each day, the tablet is made by pharmaceutical firm Eli Lilly, which additionally manufactures the favored weight-loss injection Zepbound.
Foundayo is a kind of remedy 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 tablet for weight reduction in the marketplace. In December, Novo Nordisk received FDA approval for its tablet type of Wegovy. The corporate’s unique model of Wegovy is a weekly injectable. Whereas the Wegovy tablet have to be taken on an empty abdomen within the morning, Lilly says Foundayo could be taken any time of day with out meals or water restrictions.
With injectable GLP-1 medicine in excessive demand, pharma firms have been racing to develop weight-loss pills, which might be preferable for some sufferers and will probably develop the marketplace for GLP-1s. Tablets are additionally simpler to fabricate than injectable medicines, which might assist preserve continuous entry for sufferers. GLP-1 medicines were in severe shortage from late 2022 via early 2025 as a result of demand outstripped manufacturing capability.
“Past provide and affordability, one of many greater limitations to adoption has been that some sufferers simply do not wish to take an injection,” says Ken Custer, govt vp of Eli Lilly. “That might 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 tablet is a better place for them to begin.”
Like injectable GLP-1s, Foundayo begins at a low dose and is progressively elevated to attenuate nausea, vomiting, and diarrhea that may include these medicine.
In a scientific trial, people taking the best dose of Foundayo over 18 months misplaced a median 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 lively ingredient in its injectables Mounjaro and Zepbound, has proven a greater than 20 % discount in weight.
For Novo Nordisk’s Wegovy tablet, research members achieved a median weight lack of 13.6 % by 16 months. There have been no head-to-head trials evaluating the efficacy of Foundayo and the Wegovy tablet.
Eli Lilly did run a study to seek out out what occurs when folks swap from an injectable GLP-1 drug to Foundayo and located that it helped folks preserve most of their weight reduction. Those that switched to the tablet from injectable Wegovy regained a median distinction of two kilos, whereas those that switched to Foundayo from Zepbound gained a median of 11 kilos. The lively ingredient in Foundayo, orforglipron, can be being studied as a possible remedy for sort 2 diabetes, obstructive sleep apnea, osteoarthritis knee ache, and different circumstances.
Foundayo is now obtainable by way of the direct-to-consumer platform LillyDirect, with transport starting April 6. Eli Lilly says Foundayo can be obtainable extra broadly throughout US retail pharmacies and telehealth suppliers shortly after that. The tablet was included in a November 2025 deal to be provided via the TrumpRx platform.
In its announcement on Wednesday, the FDA stated it reviewed Foundayo in simply 50 days as a part of a 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.
