Eli Lilly's Foundayo Gets FDA Nod, Enters Oral GLP-1 Weight Loss Drug Race

The U.S. Food and Drug Administration has approved Eli Lilly's once-daily GLP-1 pill, Foundayo, a milestone for the pharmaceutical giant and a pivotal moment in the evolving weight loss drug market. The pill, which will begin shipping via Lilly's direct-to-consumer platform on Monday, is expected to be available at pharmacies and telehealth services shortly thereafter. Eli Lilly's CEO, Dave Ricks, emphasized the drug's accessibility and ease of use, positioning it as a complementary option to the company's injectable GLP-1 medications. Foundayo, licensed from Japanese firm Chugai in 2018 for $50 million upfront, is anticipated to generate $14.79 billion in sales by 2030, according to FactSet projections. This figure lags behind the projected $24.68 billion for Zepbound and $44.87 billion for Mounjaro, both of which are marketed for diabetes and obesity. The approval places Eli Lilly in direct competition with Novo Nordisk, whose oral Wegovy pill launched just months earlier. Novo reported over 600,000 prescriptions for its oral Wegovy in March, indicating strong early demand. Ricks noted that Foundayo's small molecule formulation offers manufacturing advantages over injectable GLP-1 drugs, enabling global scalability and reducing supply chain constraints. Lilly plans to seek approval for Foundayo in more than 40 countries within the next year, supported by over $55 billion in manufacturing investments since 2020. The company's strategy focuses on expanding access to GLP-1 therapies, with Ricks stating that the goal is to provide patients with options that align with their health needs and preferences, whether through pills or injections.