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Foundayo ™ (orforglipron) tablet
0.8 mg / 2.5 mg / 5.5 mg / 9 mg / 14.5 mg / 17.2 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Has the FDA required additional post‑marketing safety monitoring for Foundayo™ (orforglipron)?
The FDA approved orforglipron based on the ATTAIN clinical program, with post-approval requirements consistent with its standard safety monitoring for newly approved medicines. These requirements were part of the process leading up to FDA approval.
See important safety information, including boxed warning, in the attached prescribing information.
Why Did the FDA Require Postmarketing Requirements (PMRs) for Orforglipron?
Postmarketing requirements (PMRs) and enhanced safety monitoring are standard for newly approved medicines.1-3
The FDA approved orforglipron based on its review of data from the ATTAIN clinical program, with post approval requirements consistent with the agency’s standard approach to ongoing safety evaluation of newly approved medicines.1-3
No hepatic safety signals have been observed for orforglipron across the phase 3 clinical program to date.4,5 In agreement with the FDA, Eli Lilly and Company will conduct 5 years of liver monitoring to actively monitor, evaluate, and report hepatic safety information as part of the postmarketing commitment.3
The FDA has not issued a newly identified safety signal for orforglipron related to hepatic safety.2
Patient safety is Lilly's top priority and we actively engage in evaluating, monitoring, and reporting safety information for all our medicines, including orforglipron.
Enclosed Prescribing Information
FOUNDAYO™ (orforglipron) tablets, for oral use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Postmarketing Requirements and Commitments: Introduction. US Food and Drug Administration. Updated August 9, 2024. Accessed April 15, 2025. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarketing-requirements-and-commitments-introduction
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- US Food and Drug Administration, Center for Drug Evaluation and Research. NDA approval letter for Foundayo (orforglipron) tablets. [NDA 220934.] April 1, 2026. Accessed April 15, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220934Orig1s000ltr.pdf
- Wharton S, Aronne LJ, Stefanski A, et al; ATTAIN-1 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist for obesity treatment. N Engl J Med. 2025;393(18):1796-1806. https://doi.org/10.1056/NEJMoa2511774
- Horn DB, Ryan DH, Giljanovic Kis S, et al; ATTAIN-2 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial. Lancet. 2025;406(10522):2927-2944. https://doi.org/10.1016/S0140-6736(25)02165-8.
Date of Last Review: April 15, 2026