FDA approves Foundayo, Lilly's oral GLP-1 pill, for adults with obesity

The FDA approved Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist taken without food or water restrictions, for adults with obesity and for adults with overweight who have at least one weight-related condition. The agency issued the decision 50 days after filing, well ahead of the January 20, 2027 PDUFA date, under its national priority voucher program. Foundayo is the second FDA-approved oral GLP-1 for obesity, after Novo Nordisk's Wegovy pill.

• Approved April 1, 2026, for adults with obesity or overweight with a weight-related condition
• Decision issued 50 days after filing; PDUFA date was January 20, 2027
• Highest 36 mg dose averaged 12.4% weight loss at 72 weeks in ATTAIN-1
• Second FDA-approved oral obesity GLP-1, after Wegovy pill