image: Figure 2. Changes in self-reported survey scores of quality of life and health. Females using 10 mg of rapamycin again had significant improvements in self-reported measures of pain at both 24 and 48 weeks (24 weeks: md = 6.765 (95% CI = 1.315–12.215), p = 0.011; 48 weeks: md = 8.071 (95% CI = 3.044–13.098), p < 0.001) (A). Additionally, improvements in measures of General Health reports were specific to the 5mg rapamycin group, increasing at 24 weeks and remaining relatively constant thereafter (24 weeks: md = 5.882 (95% CI = 0.388–11.376), p = 0.033; 48 weeks: md = 5.882 (95% CI = 1.350–10.415), p = 0.007) (B), however, improvements in Emotional Well-being were only seen for 5mg rapamycin users and placebo groups after 48 weeks (5mg: md = 5.176 (95% CI = 0.056–10.297), p = 0.047; placebo: md = 4.267 (95% CI = 0.432–8.102), p = 0.025) (C). md = mean difference, *=p ≤ 0.05, **p ≤ 0.01. Error bars represent standard error of the mean.
Credit: Copyright: © 2025 Moel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
“Low-dose, intermittent rapamycin administration over 48 weeks is relatively safe in healthy, normative-aging adults, and was associated with significant improvements in lean tissue mass and pain in women.”
BUFFALO, NY — May 7, 2025 — A new research paper was published in Aging (Aging-US) Volume 17, Issue 4, on April 4, 2025, titled “Influence of rapamycin on safety and healthspan metrics after one year: PEARL trial results.”
A research team led by first author Mauricio Moel and corresponding author Stefanie L. Morgan from AgelessRx conducted a clinical trial to determine whether low-dose, intermittent rapamycin could safely improve healthspan in older adults. The findings suggest rapamycin may offer measurable benefits for physical function and overall well-being, reinforcing its potential as a safe intervention to support healthy aging.
Aging remains the leading cause of chronic conditions such as heart disease, diabetes, and dementia. While medical advances have extended lifespan, many people still experience declining health and reduced mobility in later years. This growing gap between lifespan and healthspan has driven interest in therapies that target aging itself. Rapamycin, an FDA-approved drug originally used in transplant medicine, has drawn attention for its ability to influence aging-related pathways in animal studies. Until recently, its safety and benefits in healthy human populations were largely unknown.
The PEARL trial is the longest study so far to explore rapamycin’s use for longevity in healthy aging adults. Researchers followed 114 participants aged 50 to 85 over 48 weeks in a randomized, double-blind, placebo-controlled design. Participants received either a placebo or 5 mg or 10 mg of compounded rapamycin once per week. The study’s primary goal was to measure changes in visceral fat, while secondary outcomes included lean muscle mass, blood markers, and quality-of-life assessments.
The trial found that low-dose rapamycin was safe and well-tolerated, with serious side effects reported at similar rates across all groups. The most frequent minor issue among rapamycin users was mild gastrointestinal discomfort. While no significant reductions in visceral fat were observed, women taking 10 mg of rapamycin showed significant gains in lean muscle and reported reduced pain. In addition, participants taking 5 mg weekly reported improvements in emotional well-being and general health, as measured by validated surveys.
“Our findings provide evidence that these rapamycin regimens are well tolerated with minimal adverse effects when administered for at least one year within normative aging individuals.”
Researchers noted some limitations, including the relatively small and health-conscious participant group, which may have limited the ability to detect larger effects. The compounded form of rapamycin used also had lower absorption than commercial versions, possibly reducing its impact.
Overall, the PEARL trial provides early clinical evidence that low-dose rapamycin may help support physical and emotional well-being in older adults. Further studies with larger and more diverse populations will be essential to confirm the study results and refine dosing strategies for broader application.
Read the full paper: DOI: https://doi.org/10.18632/aging.206235
Corresponding authors: Stefanie L. Morgan – stefanie@agelessrx.com
Keywords: rapamycin, aging, healthspan, longevity, geroscience
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Journal
Aging-US
Method of Research
News article
Subject of Research
People
Article Title
Influence of rapamycin on safety and healthspan metrics after one year: PEARL trial results
Article Publication Date
4-Apr-2025
COI Statement
GH, VL, AN, MM, SM, AI, and SZ are employees and shareholders of AgelessRx.