Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.
FDA status
Approved
Approved. Sirolimus (rapamycin) is the active ingredient in Rapamune, FDA-approved to prevent organ rejection. That approval is not an approval for longevity use.
Drugs@FDA: Rapamune (NDA 021083)By signing up you agree to get PeptideX update emails. Unsubscribe anytime. Educational only, not medical advice.
Evidence tier
Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 4/5. 14,200 PubMed citations indexed.
Macrolide that inhibits mTORC1 complex by binding FKBP12, suppressing protein synthesis and cell proliferation; activates autophagy and extends lifespan in multiple model organisms.
What the literature studies
mTOR Inhibition & Longevity
Evidence tier
Human RCT
Compounding record
Status not verified
Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
Regulatory source not verified; no checked date is assigned.
immunosuppression and wound healing impairment at clinical.
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Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.