Eli Lilly announced that the U.S. Food and Drug Administration approved its oral GLP‑1 receptor agonist, Foundayo (orforglipron), for adults with obesity or overweight who have weight‑related medical conditions. The approval, granted on April 1, 2026, makes Foundayo the second oral GLP‑1 weight‑loss drug to receive U.S. clearance after Novo Nordisk’s Wegovy pill, which was approved on December 22, 2025.
The ATTAIN‑1 trial demonstrated that patients on the highest dose of orforglipron lost an average of 27.3 pounds (12.4 % of body weight), while the overall average weight loss across all doses was 25 pounds (11.1 %). In addition to weight loss, the drug lowered cardiovascular risk markers such as waist circumference, cholesterol, triglycerides, and blood pressure, underscoring its potential to improve overall metabolic health.
Foundayo will be launched through Lilly’s LillyDirect platform. Free home delivery will begin on April 6 for commercially insured patients, and self‑pay individuals will pay $149 for the first month. The pill can be taken once daily at any time of day without food or water restrictions, a convenience advantage over the oral semaglutide (Wegovy) that requires dosing with food or water.
The approval expands Lilly’s obesity strategy beyond its injectable portfolio of Zepbound and Mounjore, which already outsell Novo Nordisk’s injectables. Foundayo is expected to generate significant global sales and could surpass Wegovy in the oral segment. The GLP‑1 receptor agonist market is large and projected to grow substantially, driven by the rising prevalence of obesity and type 2 diabetes. Foundayo’s small‑molecule, non‑peptide design binds a different site on the receptor, leading to a lower incidence of nausea and vomiting compared with peptide GLP‑1s and enabling the once‑daily oral dosing without food or water restrictions.
Financially, Lilly’s Q4 2025 earnings, released on February 4, 2026, reported revenue of $19.3 billion, a 43 % increase versus Q4 2024, and full‑year 2025 revenue of $65.2 billion, a 45 % increase versus 2024. Gross margin rose to 82.5 % of revenue, driven by a favorable product mix and improved production costs, while R&D expenses increased 26 % due to pipeline investments. Lilly’s 2026 guidance projects revenue of $80 billion to $83 billion and non‑GAAP EPS of $33.50 to $35.00. The company expects Foundayo to contribute to its second‑quarter 2026 financial results.
David A. Ricks, Lilly’s chair and CEO, said in February 2026, “2025 was an important year for Lilly,” highlighting the submission of orforglipron and expanded access to obesity medicines. He added, “Entering our 150th year with a deep pipeline and platforms like LillyDirect, we’re positioned to reach more patients than ever and expand our global health impact.”
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