Rapamycin

Rapamycin and sirolimus are the same active substance. Product-specific sirolimus approvals and mouse lifespan results do not establish healthy-human longevity or cognitive benefit.

tier D · focus · -2.13 reps primary ITT chair-stand difference in RAPA-EX-01, p=0.089

verdict

Dietary rapamycin extended lifespan measures in UM-HET3 mice, but small human aging trials have not established a primary functional, visceral-fat, lifespan, broad healthspan, or cognitive benefit.

the core tension

mTOR inhibition has established pharmacology and mouse lifespan evidence. The leap to healthy-human longevity remains unsupported by the small human trials, and the approved product's immunosuppressive risks remain part of the page.

what it is

Sirolimus and rapamycin are the same active substance. Rapamune is systemic oral sirolimus, Hyftor is a distinct topical gel, and Fyarro is a distinct intravenous albumin-bound product; everolimus and temsirolimus evidence is not merged into this page.

what it does

Sirolimus binds FKBP-12 and the resulting complex inhibits mTOR, suppressing cytokine-driven T-cell activation and proliferation. That pharmacology supports defined transplant and LAM uses, not an inevitable aging outcome.

origin

Rapamune is approved for renal-transplant rejection prophylaxis in defined regimens and for lymphangioleiomyomatosis. It has no healthy-aging, longevity, lifespan-extension, or cognitive-enhancement indication.

does it work

The NIA dietary study supports mouse lifespan extension. In people, RAPA-EX-01 had a nonsignificant primary ITT chair-stand result, while PEARL had a null primary visceral-adiposity endpoint, low measured compounded-product exposure, and denominator limitations.

key facts

• molecular formula: C51H79NO13
• molecular weight: 914.2 g/mol
• amino acids: n/a (macrocyclic small molecule, not a peptide)
• half-life: 62 +/- 16 h after multiple systemic oral dosing in stable renal-transplant patients
• type: sirolimus, also called rapamycin; FKBP-12 and mTOR inhibitor
• CAS: 53123-88-9
• 40 older adults randomized in RAPA-EX-01
• 129 PEARL registry enrollment, not a claimed randomized denominator
• 42 ppm highest chronic mouse dietary concentration, not a human dose

frequently asked questions

Is rapamycin approved for healthy aging?

No. Sirolimus has product-specific transplant and LAM approvals, but it is not approved for healthy aging, longevity, or lifespan extension.

What did RAPA-EX-01 find?

RAPA-EX-01 randomized 40 older adults to 6 mg weekly for 13 weeks alongside standardized home-based, self-performed exercise. The primary ITT chair-stand endpoint was not significant.

Were adverse events the same in RAPA-EX-01?

The proportion with any event was 85% in both arms, but event counts were 99 with sirolimus versus 63 with placebo. Equal proportions do not erase the higher count.

Were all 129 PEARL participants randomized and analyzed?

The registry reports actual enrollment of 129. The paper reports 114 completers and 11 discontinuations, leaving four participants unreconciled in its main text, so this page does not call 129 randomized.

Is NCT06658093 the published 2026 trial?

No. NCT06658093 is recruiting with no results and is separate from completed RAPA-EX-01.

related peptides

• Metformin: The rapamycin evidence cited on this page does not establish metformin's identity, diabetes outcomes, aging outcomes, or safety record.

reptides grades the research record and cites the literature behind every call. research reference only; not medical advice.