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LongevityLimited human evidence

SS-31 (Elamipretide)

Stealth BioTherapeutics' mitochondria-targeted tetrapeptide. Binds cardiolipin in the inner mitochondrial membrane and improves electron transport chain efficiency. Multiple Phase 3 trials in genetic mitochondrial diseases (Barth syndrome, primary mitochondrial myopathy) with mixed regulatory outcomes.

Educational only — not medical advice. SmartPeptide does not prescribe, diagnose, or treat. Always consult a licensed healthcare provider before using any peptide, supplement, medication, or protocol.

What the research shows

Phase 3 trials in Barth syndrome and primary mitochondrial myopathy show meaningful improvements in muscle function in specific subgroups. Heart failure trials had mixed results. FDA approval status varies by indication and is evolving.

What's still experimental

Use outside FDA-recognized genetic mitochondrial diseases is experimental. Anti-aging / longevity applications are extrapolated from mechanism + animal data, not from RCTs in healthy adults.

Anecdotal / community reports

Longevity-focused communities discuss SS-31 for general mitochondrial support / age-related muscle decline. These uses are not supported by published RCTs in healthy adults.

Anecdotal reports are NOT scientific evidence. They reflect personal experience and may not generalize.

FDA approval status

Source: openFDA + DailyMed (NIH/NLM)
No FDA-approved drug label exists for “SS-31 (Elamipretide)”. This peptide is not currently approved by the FDA as a finished pharmaceutical product. Any commercial product claiming FDA approval should be treated with suspicion.

Doses studied in research

No established dose range

What published trials tested or FDA-approved labels specify. Reporting research facts — not a SmartPeptide recommendation.

No FDA-approved or established trial dose range for this peptide. Anecdotal ranges discussed in community forums exist but are not supported by published clinical trials, and SmartPeptide will not publish unverified doses.

This is the honest answer for peptides like BPC-157, IGF-1 LR3, MOTS-c, Epitalon and similar research compounds — robust human dose- ranging studies have not been published. Always work with a licensed clinician familiar with experimental peptides if you are considering any use.

How clinicians typically protocol this

Third-party reference · not our recommendation

Dosing phases, cycle lengths, and administration timing as listed in a compounding-pharmacy clinician reference guide. Shown so you can see what a real protocol looks like — and bring informed questions to a licensed clinician.

Third-party protocol referenceCompounding-pharmacy clinician protocol reference (Nov 2025)

Dose numbers, frequencies, and cycle lengths in this panel are extracted from a clinician-facing reference protocol distributed by a US-based compounding pharmacy in November 2025. SmartPeptide has paraphrased all descriptive text and adds no endorsement. Always consult a licensed clinician.

Energy Support

Mitochondria-targeted tetrapeptide (Elamipretide) that binds cardiolipin on the inner mitochondrial membrane.

Protocol phases

Research (subcutaneous)
10 mg3× weekly
subcutaneous
Therapeutic (subcutaneous)
2 mgdaily
subcutaneous
IV infusion
0.01–0.25 mg/kg/hrover 4-hour infusion
IV

clinical setting only

Cycle length

Cycle length varies; the reference notes >4-week human data is limited.

Reconstitution calculator Storage & reconstitution guide
Not medical advice. SmartPeptide does not prescribe, diagnose, or treat. The protocol above reproduces dose figures from a third-party clinician reference so you can see what compounding-pharmacy guidance typically looks like — it is not a recommendation for you, and it has not been validated against peer-reviewed dose-ranging trials. Many of these compounds are not FDA-approved for human use. Work with a licensed clinician familiar with peptide therapy before considering anything here.

FDA enforcement & recalls

Live · openFDA Drug Enforcement API
No FDA enforcement actions (recalls, market withdrawals, safety alerts) on record for “SS-31 (Elamipretide)”. This is the expected baseline for most peptides — the absence of recalls does NOT imply general safety, only that no formal FDA enforcement has been initiated against approved formulations.

Mechanism & targets

ChEMBL · UniProt · Open Targets

Molecule (ChEMBL)

View on ChEMBL
Formula
C32H52Cl3N9O5

Live research

PubMed · ClinicalTrials.gov · Europe PMC · OpenAlex
PubMed papers
522
total
Human studies
0
MeSH: humans
Clinical trials
0
published
Active trials
2
21 total registered

Clinical trials (ClinicalTrials.gov)

All trials for "elamipretide"

Europe PMC — 367,562 additional records

Includes EU/UK studies and PubMed Central full-text articles. Often surfaces research weeks before PubMed indexes it.

Human clinical evidence

Semantic Scholar · AI TLDRs · influence-ranked
Total indexed
3
all human + lab studies
Meta-analyses
0
highest evidence
Systematic reviews
1
quality-weighted
Clinical trials
0
published RCTs etc.

Most influential human studies

Ranking blends meta-analysis > systematic review > clinical trial weight with influential-citation count and recency. AI TLDRs by Semantic Scholar / Allen Institute for AI.

Research funding & verification

NIH RePORTER · CrossRef DOI registry

Publication landscape

CrossRef · DOI registry
Indexed works (CrossRef)
2,794,454
all DOIs registered
Retracted papers
0
no retractions on record
Top funders of indexed research
  • National Natural Science Foundation of China42,214 works
  • National Institutes of Health7,752 works
  • National Science Foundation6,573 works
  • National Key Research and Development Program of China4,880 works
  • Fundamental Research Funds for the Central Universities4,357 works
  • DOE4,137 works

Funder diversity is a credibility signal. Research concentrated in a single drug company's funding warrants more scrutiny than research funded across NIH, charities, and academic grants.

Preprints — cutting edge

bioRxiv · medRxiv · via Europe PMC

Preprints have NOT been peer-reviewed. They are early research shared by authors before formal validation. Treat findings as preliminary.

Showing 6 of 4,255 preprints indexed by Europe PMC.

Known risks

Injection-site reactions (notable in trials). Headache, GI symptoms. Long-term safety being characterized. FDA has issued complete-response letters on prior submissions — efficacy outside specific genetic indications remains debated.

Reported side effects

Injection-site erythema (common), headache, nausea, dizziness, fatigue.

FDA adverse event reports (FAERS)

Updated quarterly by FDA
No reports found in the FDA Adverse Event Reporting System for “SS-31 (Elamipretide)”. This is normal for research-only peptides that are not marketed as FDA-approved drugs.

What requires medical supervision

Restricted to clinical trials or specific approved indications. Off-label use should only be under a clinician familiar with mitochondrial medicine.

Questions for your clinician

  • Do I have any indication where SS-31 has demonstrated efficacy?
  • What's the evidence vs. mechanism-based extrapolation distinction for my use case?
  • Are there active trials I could enroll in?

Editorially curated references

Discussions about SS-31 (Elamipretide)

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