FDA approves Foundayo, an oral weight‑loss pill

The FDA granted expedited approval to Eli Lilly's oral GLP‑1 pill Foundayo (orforglipron), a once‑daily small‑molecule tablet expected to begin shipping Monday; clinical trials showed about 11.2% average weight loss at the highest dose versus 2.1% for placebo.

Federal regulators approved Eli Lilly's oral weight‑loss pill Foundayo, the brand name for orforglipron. The FDA granted expedited approval for the small‑molecule GLP‑1 drug, which is taken once daily. It mimics a natural hormone that helps regulate appetite and fullness and is designed to be taken without dietary restrictions. The approval provides an oral alternative to injectable GLP‑1 treatments for obesity and related weight‑associated conditions. Key details: - The FDA reviewed Lilly's application under a fast‑track process and granted expedited approval to orforglipron, to be sold as Foundayo. - Foundayo is a small‑molecule GLP‑1 designed for once‑daily oral dosing and does not require the timing and fasting restrictions used by some peptide‑based oral GLP‑1 pills. - In a trial of more than 3,000 adults with obesity, participants on the highest 36 mg dose lost an average of 11.2% of body weight (about 25 pounds) over more than 16 months, compared with 2.1% for placebo. - Eli Lilly said shipments are expected to begin Monday; with the company discount card, insured patients may access the drug starting at about $25 per month, while cash prices were reported between $149 and $349 depending on dose. - Gastrointestinal side effects led between 5% and 10% of participants taking orforglipron to discontinue treatment, versus nearly 3% of those on placebo. Summary: The approval adds a second once‑daily oral GLP‑1 option in the United States and may broaden access for people who have been unable or unwilling to use injectable treatments. Shipments are expected to begin Monday, and the FDA completed its review in roughly 50 days under a fast‑track review program.