Approval status
Retatrutide FDA approval status
As checked on May 2, 2026, retatrutide is not FDA approved for public sale or prescription. Lilly describes retatrutide as investigational, and FDA says retatrutide is not a component of an FDA-approved drug.
What FDA says
FDA's GLP-1 safety page says retatrutide and cagrilintide cannot be used in compounding under federal law, are not components of FDA-approved drugs, and have not been found safe and effective for any condition.
FDA also warns that some products sold online as retatrutide and labeled for research use may be unapproved drugs marketed to consumers, with unknown quality and potential harm.
Source: FDA GLP-1 safety page
What Lilly says
Lilly says retatrutide is investigational, not yet available for public use, and legally available only to participants in Lilly clinical trials while safety and efficacy are being evaluated.
Source: Lilly retatrutide FAQ
What this means for this site
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Related pages: clinical trials, approved treatment paths, online listing warnings, and methodology.