The FDA has approved Eli Lilly’s oral obesity drug orforglipron, set to be marketed as Foundayo, intensifying competition in the global weight loss drug market.
The once-daily GLP-1 pill is slated for release April 6. In clinical trials, patients lost roughly 12-15% of their body weight. A key advantage over some competitors is its flexibility — Foundayo can be taken with or without food, removing a restriction that applies to certain rival treatments.
Lilly CEO David Ricks called the drug suitable for both weight loss and weight maintenance and said the company has sought approval in more than 40 countries.
The approval marks Lilly’s formal entry into a market currently dominated by Novo Nordisk, whose injectable GLP-1 treatments Wegovy and Ozempic have captured significant market share. Novo Nordisk has also introduced an oral version of Wegovy.
Analysts see Foundayo as a meaningful competitive threat. “The ability to take it regardless of meals could significantly boost its initial market penetration,” said BMO analyst Evan Seigerman.
Injectables currently lead the GLP-1 market, but oral options are expected to draw in new patients. Novo Nordisk has noted that most users of its oral medications are first-time GLP-1 patients. Experts generally expect pills to complement rather than replace injectables, as injections tend to produce greater weight loss.
Oral obesity treatments are forecast to capture roughly 20% of the total market by 2030.
Foundayo is priced at $149 per month for the lowest dosage for patients paying out of pocket. The drug carries warnings about gastrointestinal side effects and potential thyroid tumor risks. The FDA approved it through its fast-track program, which expedites review of drugs with significant public health impact.