FDA approves Foundayo, Eli Lilly’s once-daily oral GLP-1 for weight management
The Food and Drug Administration has approved Eli Lilly’s Foundayo, a once-daily oral glucagon-like peptide-1 (GLP-1) receptor agonist known as orforglipron, offering a noninjectable option for weight management.
The decision, for adults with obesity or overweight with weight-related medical problems, was expedited through the FDA’s Commissioner’s National Priority Voucher (CNPV) program, an initiative designed to speed access to treatments addressing major public health needs.
Foundayo becomes the second GLP-1 drug available in pill form, following Wegovy, which gained approval in December 2025. Clinical data suggests Foundayo supports meaningful weight loss compared with placebo and can be taken without strict food or timing requirements, which could improve ease of use and adherence for some patients.
GLP-1 receptor agonists have reshaped treatment for obesity and type 2 diabetes in recent years. Evidence suggests roughly one in eight U.S. adults report having ever used a GLP-1 medication, with 6% currently using such drugs. Obesity remains a major global health concern and increases the risk of conditions such as type 2 diabetes, cardiovascular disease, and certain cancers, fueling demand for GLP-1–based therapies.
In March 2026, a phase 3 clinical trial of oral orforglipron suggested it can lower blood sugar levels at least as well as, and in some cases better than, oral semaglutide. Like other GLP-1 drugs, the once-daily pill mimics the GLP-1 hormone, which helps regulate appetite and food intake.
“There is no single path that works for everyone living with overweight or obesity,” said Joe Nadglowski, president and CEO of the Obesity Action Coalition. New treatment options, he noted, expand choice and help people find care that fits their goals and circumstances.
Richard Frank, MD, MHSA, Chief Medical Officer at Vida Health, said the choice between a pill and an injectable often comes down to patient preference and potency; injectables are clearly more potent but require weekly injections, while pills do not require a needle and may appeal to some patients.
Foundayo is among the first medications approved under the FDA’s new CNPV program, underscoring regulators’ focus on accelerating therapies for major public health needs. As oral formulations expand, they may broaden access to treatment, particularly for people reluctant to use injectable medications.