Is Metformin plus rapamycin legal in the United States?

Fed together from 9 months, metformin 1,000 ppm and rapamycin 14 ppm extended median mouse lifespan 23 percent in both sexes. Metformin alone in the same cohort did nothing, there was no rapamycin-alone arm to compare against, and the ITP's own paper says the apparent extra benefit over historical rapamycin cohorts did not reach significance by its protocol test.

This is a page about one arm of one mouse experiment, because that arm is cited across the longevity world as evidence that metformin and rapamycin are synergistic, and the paper that reports it says something more careful. Both drugs have their own pages on this site; this entry is about what happens when they are combined.

Mechanism: Rapamycin inhibits mTORC1, and at the doses used in mice lowers cancer incidence, alters immune function and shifts metabolism in ways that are distinct from dietary restriction. Metformin inhibits mitochondrial complex I, activates AMPK in some tissues and lowers hepatic glucose output.

Regulatory history: Both drugs are FDA-approved for other indications (metformin for type 2 diabetes, rapamycin as sirolimus for transplant rejection and other uses). The combination is not approved for anything. The lifespan result is in mice and lacks a contemporaneous rapamycin-alone comparison.

Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.

The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for Metformin plus rapamycin at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.