The FDA on April 1 approved Eli Lilly’s daily GLP-1 pill, Foundayo, making it the U.S. market’s second oral GLP-1 drug for treating obesity.
The first oral GLP-1 approved for weight loss is Novo Nordisk’s Wegovy pill (semaglutide), which the FDA approved in December; it quickly surged in popularity. Novo Nordisk said April 2 that the Wegovy pill demonstrated more weight loss than orforglipron in an indirect comparison study.
Eli Lilly’s Foundayo (orforglipron) is indicated for adults with obesity or overweight with at least one weight-related comorbid condition. In a phase 3 clinical trial, patients who took the highest dose of Foundayo every day lost an average of 27.3 pounds, or 12.4% of their body weight, after 72 weeks.
The drugmaker said the GLP-1 pill will be available April 6 through its direct-to-consumer website before becoming available at retail pharmacies and telehealth providers. Self-paying patients can access the drug for $149 per month for the lowest starting dose.
As part of the FDA’s national priority voucher program — which launched in 2025 to expedite new drug reviews and approvals — the agency said it approved Foundayo 50 days after Eli Lilly submitted its application. The decision is also the fastest FDA approval of a new molecular entity since 2002.
Eli Lilly said it is investigating orforglipron as potential treatments for Type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.
Editor’s note: This article was updated April 2 to include information from Novo Nordisk’s comparison study.
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