U.S. Food and Drug Administration (FDA)
Is Orforglipron legal in United States?
ApprovedFDA-approved on 1 April 2026 as Foundayo, a tablet for obesity, or overweight with a weight-related condition
The regulator has approved it as a medicine.
Orforglipron (brand Foundayo, Eli Lilly) received FDA approval on 1 April 2026 as a GLP-1 receptor agonist tablet to reduce excess body weight and maintain weight reduction long term in adults with obesity, or with overweight plus at least one weight-related condition. Lilly reported in its June 2026 quarterly filing that it has also submitted orforglipron for type 2 diabetes in the US, EU and Japan; that use is not yet approved. Foundayo is one of the drugs covered by the temporary Medicare GLP-1 Bridge that began on 1 July 2026.
Last verified 2026-09-29 · how we verify
Orforglipron elsewhere
Sources (3)
- 01FOUNDAYO (orforglipron) tablets prescribing information (original approval)U.S. Food and Drug Administration · 2026-04 · accessed 2026-09-29
- 02Eli Lilly and Company Form 10-Q for the quarter ended 30 June 2026Eli Lilly and Company (SEC filing) · 2026-08-05 · accessed 2026-09-29
- 03Medicare GLP-1 Bridge: who is eligible and which drugs are coveredMedicare.gov (CMS) · 2026 · accessed 2026-09-29