Elamipretide (SS-31)
Supplied by U.S. pharmacies.
Description
Formulation and Ingredient Facts
Elamipretide (SS31) is a compounded injectable peptide.
Compounded Elamipretide SS31 Formulation Details
Elamipretide (SS31) is listed as an injectable vial in the supplied pharmacy documentation. The names SS31 and elamipretide designate the same synthetic peptide.[1]
What Primary Research Shows for Elamipretide SS31
The cited phase 3 trial investigated elamipretide against placebo in participants with a diagnosed mitochondrial condition.[3] Investigators assessed walking distance and fatigue.[3] The cited study did not demonstrate statistically significant improvements over placebo for its primary walking distance or fatigue endpoints.[3]
The cited trial enrolled patients with a specific diagnosed condition rather than healthy adults seeking general wellness outcomes.[3] The cited study does not substantiate energy or recovery claims for this compounded product.[3]
Distinguishing Compounded Formulations From Approved Therapies
The Food and Drug Administration (FDA) granted accelerated approval to a separate commercial elamipretide injection for a specific condition.[1] That accelerated approval requires a further trial to confirm clinical benefit.[1] That regulatory decision applies exclusively to the manufacturer's finished pharmaceutical product.[1][2] The supplied Revive catalog lists an SS31 injectable vial. It does not share that commercial medicine's FDA approval or verified therapeutic equivalence.[2][1]
Frequently asked questions
What is the relationship between elamipretide and SS31?
The designations SS31 and elamipretide identify the exact same synthetic peptide molecule.[1]
What did the cited clinical trial measure?
The cited study measured walking distance and fatigue in participants with a diagnosed mitochondrial condition.[3]
Does published clinical research confirm energy benefits for elamipretide SS31?
The cited trial does not establish general energy or stamina improvements for healthy adults.[3] That trial did not meet its primary walking-distance or fatigue endpoints.[3]
Why does commercial elamipretide approval differ from this compounded injection?
The FDA granted a separate commercial elamipretide injection accelerated approval for a specific condition.[1] That accelerated approval requires a further trial to confirm clinical benefit.[1] That regulatory determination does not transfer to compounded SS31 formulations produced by compounding pharmacies.[2][1] Compounded medications remain unapproved by the FDA and lack premarket verification of therapeutic equivalence.[2]
Research and information sources
Material Safety and Regulatory Considerations
The FDA announcement for the separate approved medicine reports injection-site reactions and serious reactions.[1] Reported adverse event rates from commercial drug trials cannot be assumed for customized compounded formulations.[1][2]
Compounded medications are not FDA-approved.[2]
Consult With an Opt Health Physician
At Opt Health, we connect members with licensed physicians who evaluate personal biomarkers and medical history through comprehensive telehealth consultations.[5] Your initial physician evaluation includes blood testing and an in-depth review of existing conditions and current medications.[4]
Get started with OptThis content is for informational purposes and does not replace evaluation, diagnosis, or treatment by a qualified medical professional.