The US Food and Drug Administration granted approval on Wednesday for a new weight-loss medication named Foundayo, developed by Eli Lilly, the creator of the injection Zepbound for weight loss. This daily medication is categorized as GLP-1, alongside rivals Ozempic and Wegovy, which imitate a hormone responsible for regulating blood sugar, digestion, and satiety.
This authorization marks the second GLP-1 weight-loss pill to hit the market. Back in December, Novo Nordisk received FDA clearance for a pill formulation of Wegovy, which was initially a weekly injection. In contrast to the Wegovy pill, which requires consumption on an empty stomach, Foundayo does not have any timing or dietary constraints associated with its intake.
In response to the strong demand for injectable GLP-1s, pharmaceutical firms are creating weight-loss pills to meet patient preferences and broaden the GLP-1 market. Pills are also simpler to manufacture, which could lead to more reliable patient access, alleviating the shortages that occurred from late 2022 to early 2025.
“Aside from supply and cost issues, a significant barrier to adoption has been patients’ hesitance to use injections,” states Ken Custer, an executive at Eli Lilly. “This could be due to the fear of needles or the notion that using an injection signals a more serious condition than they recognize. A pill could serve as a more approachable initial step for individuals embarking on their weight management journey.”
Similar to injectable GLP-1s, Foundayo begins with a low dosage to reduce the risk of nausea, vomiting, and diarrhea, with a gradual uptick in amounts. Clinical trials revealed that the highest dosage of Foundayo resulted in an average weight decrease of 27 pounds, or 12.4% of total body weight, across 18 months. The placebo group experienced only a 2-pound loss. The active component, tirzepatide, which is present in Mounjaro and Zepbound injections, demonstrated more than a 20% weight reduction.
In the Wegovy pill study conducted by Novo Nordisk, participants achieved an average weight loss of 13.6% over a span of 16 months. Direct comparisons between Foundayo and the Wegovy pill have not been conducted. Eli Lilly’s research on patients transitioning from injectable GLP-1 medications to Foundayo indicated sustained weight loss. Those switching from the injectable Wegovy gained 2 pounds, while patients coming from Zepbound gained 11 pounds. The active ingredient, orforglipron, is also being explored for treating type 2 diabetes, sleep apnea, and various other conditions.
Foundayo is currently available via LillyDirect, with shipping commencing on April 6. It will soon be widely offered at pharmacies across the US and through telehealth services. The pill is part of a deal established in November 2025 with TrumpRx. The FDA evaluated Foundayo within 50 days under a pilot initiative aimed at speeding up the review of medications that align with national health priorities. Typically, the approval process spans six to ten months.