The FDA approved Foundayo (orforglipron) on April 1, 2026. It is a once-daily tablet from Eli Lilly for adults with obesity, or with overweight and at least one weight-related condition, used alongside diet and exercise.
What changed. Orforglipron is the first approved GLP-1 drug that is a small molecule rather than a peptide. The label says it can be taken “with or without food.” The FDA reviewed it under its Commissioner’s National Priority Voucher pilot and approved it 50 days after filing, which the agency called its fastest approval of a new molecular entity since 2002. The label starts at 0.8 mg a day and steps up after at least 30 days on each dose, to a maximum of 17.2 mg.
What it means. There is now an approved oral GLP-1 option without an empty-stomach rule. In the 72-week trials behind the approval, average weight loss on the top dose was 11.1% in people without diabetes, versus 2.1% on placebo. That is less than the injectable drugs produced in their own trials.
If you take this or are considering it. The choice these numbers set up is convenience against size of effect: a daily tablet with no food rule, and average weight loss of 11.1% on the top dose, less than the injectable drugs reached in their own separate trials. It is also a slow start, since the label moves up from 0.8 mg only after at least 30 days on each dose. The label, revised July 2026, says use with another GLP-1 is not recommended, so tell your prescriber about any GLP-1 you already take. Weight management is still the only US use. Lilly’s chief executive said on October 29, 2026 that a type 2 diabetes use is under review.
What has not changed. Foundayo carries the same boxed warning about thyroid C-cell tumors as other GLP-1 drugs, needs a prescription, and is not approved for type 2 diabetes on its current label. The orforglipron guide covers doses, side effects and price.