CClinicalTrials.gg
CompletedNCT06550271Updated Aug 13, 2024

The Bioavailability of Compounded and Generic Rapamycin in Normative Aging Individuals

An observational study in Aging, sponsored by AgelessRx. Completed at 1 site in United States. Open to participants aged 40 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by AgelessRx · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
67
Ages
40 Years to 120 Years
Sex
All
01

Study summary

This study collected real-world evidence to better understand and define the relative bioavailability ratio between compounded rapamycin and generic rapamycin, with a specific focus on relative efficacy in increasing rapamycin levels in the blood (blood rapamycin levels).

02

Conditions studied

  • Aging

Keywords

  • Bioavailability
  • Rapamycin
  • Aging
  • Longevity
  • Sirolimus
  • Healthy aging
  • age-related conditions
  • energy improvement
03

In context

Lead sponsor

AgelessRx is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants who sought rapamycin prescription for longevity support, pain reduction, energy improvement, weight loss, mood improvement, sleep improvement, or oral health improvement were included in the study. To be eligible to receive AgelessRx's standard rapamycin treatment protocol, participants had to be ≥40 years of age, without a history of uncontrolled disease. All patients treated with rapamycin and opted for at least one blood draw test between May 1, 2023, and December 15, 2023, were included in this retrospective study.

Inclusion criteria

  • Receive AgelessRx's standard Rapamycin treatment protocol
  • Opted to complete at least 1 blood draw at their local Quest Lab

Exclusion criteria

Exclusion Criteria:

  • Not approved for current AgelessRx standard Rapamycin treatment
  • History of uncontrolled disease
  • Unable to complete at least 1 blood draw at their local Quest Lab
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
67 participants (actual)
Patient registry
No

Groups and cohorts

  • Compounded Rapamycin

    Participants in this group were receiving Compounded Rapamycin (dosages include 5, 10, or 15mg) once per week

    Drug: Rapamycin

  • Generic Rapamycin

    Participants in this group were receiving Generia Rapamycin (dosages include 2,3,6, or 8mg) once per week

    Drug: Rapamycin

Interventions

  • DrugRapamycin

    Rapamycin in 2 different dosage forms (compounded and generic)

    Also known as: Sirolimus, Rapamune, Rapacan, Siromus, Raparen, Rapasim, Sirova

06

What researchers measure

Primary outcomes

  1. define the relative bioavailability ratio between compounded rapamycin and generic rapamycin

    define the relative bioavailability ratio between compounded rapamycin and generic rapamycin, with a specific focus on relative efficacy in increasing rapamycin levels in the blood (blood rapamycin levels).

    Time frame: 8 months

07

Study locations

1 site
  • AgelessRx
    Ann Arbor, Michigan 48104, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06550271
Lead sponsor
AgelessRx
Responsible party
Sponsor
First posted
Aug 13, 2024
Start date
Apr 25, 2023
Primary completion
Dec 15, 2023
Completion
Dec 15, 2023
Last update
Aug 13, 2024

Study contacts

Sajad Zalzala, MD
study director · AgelessRx

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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