SS-31

SS-31 is a mitochondria-targeted peptide that concentrates in the inner mitochondrial membrane to reduce oxidative stress, commonly used off-label for mitochondrial health, anti-aging, and muscle performance. Users typically run daily doses of 5 mg, though reported protocols range widely from 200 µg to 50 mg. While users occasionally report changes in sleep quality and dream intensity, injection-site reactions and systemic side effects like nausea or fluid retention have not been a consistent theme. Readers should note that the clinical evidence base for these exploratory indications remains thin, with most studies lacking posted results and no insurance pathway available for off-label use.

Half-life~4 h

Data last updated June 13, 2026

Source data

Every row behind the score.

43 total

RCTNCT01115920Phase 1 · 2010 · n=40 · Stealth BioTherapeutics Inc.

Pharmacokinetic / healthy volunteer studies

tested Treatment emergent adverse events in treatment group versus placebo group

result Completed; results not posted

RCTNCT01513200Phase 1 · 2012 · n=12 · Stealth BioTherapeutics Inc.

Pharmacokinetic / healthy volunteer studies

tested Mean difference over 24 hours in aPTT (activated partial prothrombin time) in seconds when UFH is administered with and without Bendavia

result Completed; results not posted

Small sample; effect at the edge of clinical significance.

RCTNCT01518985Phase 1 · 2012 · n=6 · Stealth BioTherapeutics Inc.

Pharmacokinetic / healthy volunteer studies

tested Analysis of variance (ANOVA) between group mean endothelial function (EndoPAT Index) following smoking a single cigarette with and without Bendavia

result Completed; results not posted

Small sample; effect at the edge of clinical significance.

RCTNCT01572909Phase 2 · 2012 · n=300 · Stealth BioTherapeutics Inc.

Reperfusion Injury

tested Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB)

result −156 ng*hr/mL (Area Under the Curve (AUC) of Serum Creatine Kinas…)

RCTNCT01754818Phase 1 · 2012 · n=30 · Stealth BioTherapeutics Inc.

Pharmacokinetic / healthy volunteer studies

tested Mean peak plasma concentration (Cmax) of Bendavia (ng/ml) in each cohort.

result Completed; results not posted

RCTNCT01755858Phase 1 · 2012 · n=16 · Stealth BioTherapeutics Inc.

Renal Artery Obstruction

tested Change in Mean Glomerular Filtration Rate (GFR), as Measured by Iothalamate Clearance, at Baseline (Pre-percutaneous Renal Artery Angioplasty and 8 Weeks Post-PTRA.

result −5.7 mL/min (Change in Mean Glomerular Filtration Rate (GFR), a…)

RCTNCT01786915Phase 1 · 2013 · n=30 · Stealth BioTherapeutics Inc.

Pharmacokinetic / healthy volunteer studies

tested Mean peak plasma concentration (Cmax) of Bendavia (ng/ml) on Day 1 in each cohort.

result Completed; results not posted

RCTNCT02245620Phase 2 · 2015 · n=41 · Stealth BioTherapeutics Inc.

Skeletal Muscle Mitochondrial Dysfunction in the Elderly

tested Change From Baseline in ATPmax (Maximal ATP Synthetic Rate)

result +0.1 mM/sec (Change From Baseline in ATPmax (Maximal ATP Synthe…)

RCTNCT02367014Phase 1 · 2015 · n=36 · Stealth BioTherapeutics Inc.

Mitochondrial Myopathy

tested Change in Distance Walked (Meters) on the 6-minute Walk Test (6MWT)

RCTNCT02388464Phase 1 · 2014 · n=36 · Stealth BioTherapeutics Inc.

Congestive Heart Failure

tested Incidence of Adverse Events

result Completed; results not posted

RCTNCT02388529Phase 1 · 2015 · Stealth BioTherapeutics Inc.

Heart Failure

tested Incidence of Adverse Events

result Withdrawn before enrolment

Withdrawn before enrolment; no public reason provided.

RCTNCT02653391Phase 1 · 2016 · n=22 · Stealth BioTherapeutics Inc.

Fuchs' Corneal Endothelial Dystrophy (FCED)

tested Incidence and Severity of Ocular TEAEs.

result +3.0 Participants (Incidence and Severity of Ocular TEAEs.)

Small sample; effect at the edge of clinical significance.

RCTNCT02693119Phase 2 · 2016 · n=12 · Stealth BioTherapeutics Inc.

Leber's Hereditary Optic Neuropathy

tested Double Masked Period: Incidence of Ocular TEAEs

result +5.0 eyes (Double Masked Period: Incidence of Ocular TEAEs)

Small sample; effect at the edge of clinical significance.

RCTNCT02788747Phase 2 · 2016 · n=71 · Stealth BioTherapeutics Inc.

Heart Failure

tested Change in Left Ventricular End Systolic Volume (ml)

result −0.6 mL (Change in Left Ventricular End Systolic Volume (ml…)

RCTNCT02805790Phase 2 · 2016 · n=30 · Stealth BioTherapeutics Inc.

Primary Mitochondrial Disease

tested Distance Walked on the 6-minute Walk Test (6MWT) by Visit

result +15.9 meters (Distance Walked on the 6-minute Walk Test (6MWT) b…)

RCTNCT02814097Phase 2 · 2016 · n=46 · Stealth BioTherapeutics Inc.

Chronic Heart Failure

tested Compare the delta in E/e' at rest exercise measured with echocardiography between the elamipretide and placebo groups

result Completed; results not posted

RCTNCT02914665Phase 2 · 2016 · n=308 · Stealth BioTherapeutics Inc.

Heart Failure

tested Change in NT-proBNP between Baseline and Day 8/Early Discharge

result Completed; results not posted

RCTNCT03098797Phase 2 · 2017 · n=12 · Stealth BioTherapeutics Inc.

Barth Syndrome

tested Part 1: Distance Walked During the 6-Minute Walk Test (6MWT) by Visit

result −12.5 meters (Part 1: Distance Walked During the 6-Minute Walk T…)

Small sample; effect at the edge of clinical significance.

RCTNCT05162768Phase 3 · 2022 · n=102 · Stealth BioTherapeutics Inc.

Mitochondrial Myopathies

tested Six-minute walk test (6MWT)

result Completed; results not posted

RCTNCT05168774Phase 1 · 2022 · n=20 · Children's Hospital of Philadelphia

Friedreich Ataxia

tested Change in High Contrast Visual Acuity

Small sample; effect at the edge of clinical significance.

RCTNCT06373731Phase 3 · 2024 · n=313 · Stealth BioTherapeutics Inc.

Age Related Macular Degeneration (ARMD)

tested Week 48 Rate of change in the macular area of photoreceptor loss

result In progress (active-not-recruiting)

RCTNCT07531251Phase 4 · 2026 · n=48 · Stealth BioTherapeutics Inc.

Barth Syndrome

tested Primary Efficacy End Point

result In progress (recruiting)

OpenNCT02314299Phase 1 · 2014 · n=20 · Stealth BioTherapeutics Inc.

Diabetic Macular Edema

tested Incidence and severity of systemic and ocular adverse events

result Completed; results not posted

Non-randomised; effect size cannot be separated from placebo.

OpenNCT02436447Phase 1 · 2015 · n=23 · Stealth BioTherapeutics Inc.

Normal and Impaired Renal Function

tested Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort

result Completed; results not posted

Non-randomised; effect size cannot be separated from placebo.

OpenNCT02848313Phase 1 · 2016 · n=40 · Stealth BioTherapeutics Inc.

Age-Related Macular Degeneration

tested Change From Baseline in Mean Standard Luminance Best-corrected Visual Acuity (BCVA)

Non-randomised; effect size cannot be separated from placebo.

OpenNCT02976038Phase 2 · 2016 · n=28 · Stealth BioTherapeutics Inc.

Primary Mitochondrial Disease

tested Distance Walked on Six Minute Walk Test

result Terminated before completion

Terminated: Registration trial did not meet the primary end points

ObsNCT04689360Stealth BioTherapeutics Inc.

Mitochondrial Diseases

result In progress (unknown)

OpenNCT07275424Phase 2 · 2025 · n=30 · David Marcinek

Aging, Healthy

tested To evaluate the safety and tolerability of daily subcutaneous injections of elamipetide: Number of participants with treatment-related adverse events and Number of participants completed 4 weeks of injection

result In progress (recruiting)

Non-randomised; effect size cannot be separated from placebo.

AnimalPMID 25165999