SS-31 (Elamipretide)

Elamipretide · Bendavia · MTP-131

Anti-AgingNot ApprovedApprovedResearchSubQ

Popular for:Mitochondrial function, anti-aging, cardiac protection

26

Registered Trials

22

Trial Publications

435

PubMed References

Approved

Evidence Level

Overview

SS-31 (Elamipretide, also known as Bendavia or MTP-131) is a synthetic aromatic-cationic tetrapeptide (D-Arg-Dmt-Lys-Phe-NH2) that targets the inner mitochondrial membrane. The short version: people usually care about it for mitochondrial function, anti-aging, cardiac protection, but the strength of the evidence depends heavily on indication and study type.

SS-31 (Elamipretide, also known as Bendavia or MTP-131) is a synthetic aromatic-cationic tetrapeptide (D-Arg-Dmt-Lys-Phe-NH2) that targets the inner mitochondrial membrane. It is one of the most promising mitochondria-targeted therapeutics, designed to restore mitochondrial function by stabilizing cardiolipin — a critical phospholipid in the electron transport chain.

**Originally developed for: **Barth syndrome (genetic mitochondrial cardiomyopathy caused by cardiolipin deficiency) and primary mitochondrial myopathy. Developed by Stealth BioTherapeutics. Also studied for cardiac ischemia-reperfusion injury, age-related mitochondrial dysfunction, and heart failure.

Research Snapshot

What the evidence says

Approved

SS-31 (Elamipretide) currently shows 26 registered trials from ClinicalTrials.gov, 22 PubMed trial publications (19 RCT-tagged), and 435 PubMed references matching the stored source query. Treat PubMed references as literature surface area, not a count of clinical trials.

Known vs uncertain

Known signals

  • 26 registered trials are tracked from ClinicalTrials.gov intervention records.
  • 22 PubMed clinical-trial publications are indexed.
  • 19 PubMed randomized controlled trial publications are indexed.
  • 435 PubMed references are tracked separately from trial counts and can include animal, in-vitro, review, mechanism, or clinical records.

Open questions

  • Evidence strength may vary by indication, route, formulation, and population.
  • Public anecdotes can highlight interest or concern but do not establish clinical efficacy.
  • Regulatory status and compounding access can change independently from the research literature.

Mechanism of Action

SS-31 readily penetrates cell membranes and concentrates 1,000-5,000x in mitochondria.

Key Research Benefits

Primary Benefits:

Restores mitochondrial function — Stabilizes cardiolipin and electron transport chain efficiency (PNAS, 2020)
Reduces oxidative stress — Decreases mitochondrial ROS production without acting as a traditional antioxidant
Improved exercise tolerance — Reversed age-related exercise decline in mice (PMC6588449)
Cardiac protection — Improved cardiac function in Barth syndrome patients (48-week trial, Nature Scientific Reports, 2024)

Secondary/Emerging Benefits:

Anti-aging — Reverses age-related mitochondrial dysfunction; may slow cellular aging
Kidney protection — Studies show renal protective effects in ischemia models
Neuroprotection — Potential benefits for neurodegenerative diseases via mitochondrial support
Skeletal muscle function — Improves muscle quality and mitochondrial content in aging

Clinical Evidence Summary

Research Pipeline

Preclinical
Animal
Phase I
Phase II
Phase III
Approved

26

Registered Trials

22

Trial Publications

19

RCT Publications

435

PubMed References

ClinicalTrials.govPubMed ESearchCurated alias queryChecked May 3, 2026

Registered trials are ClinicalTrials.gov intervention records. Trial publications are PubMed records tagged as clinical trials or randomized controlled trials. PubMed references are broader source-query matches and can include animal studies, in-vitro work, reviews, mechanism papers, and trial publications.

26

Registered trials

22

Trial publications

19

RCT publications

435

PubMed references

82

Reviews

1

Meta-analyses

Registered trials source

Jun 1, 2026

Elamipretide, SS-31, MTP-131

Uses curated ClinicalTrials.gov intervention aliases to avoid misleading registry matches.

View source

Publication counts source

May 3, 2026

SS-31, Elamipretide, Bendavia, MTP-131

Uses SS-31 and Elamipretide aliases instead of the parenthetical display label.

View source

- TAZPOWER Trial — Phase 2 trial in Barth syndrome. 40 mg/day for 48 weeks showed improvement in 6-Minute Walk Test and cardiac function.

- Neurology (2018) — Randomized dose-escalation trial in primary mitochondrial myopathy. Doses of 5-50 mg/day were well-tolerated.

- PNAS (2020) — Mapped the mitochondrial protein interaction landscape of SS-31, revealing binding to ATP synthase and other key complexes.

- Campbell et al. (2019, PMC6588449) — SS-31 reversed age-related redox stress and improved exercise tolerance in aged mice.

> Clinical trial status: Multiple Phase 2 trials completed for Barth syndrome, mitochondrial myopathy, and heart failure. Stealth BioTherapeutics has faced regulatory setbacks. The compound has strong preclinical data but has not yet achieved FDA approval. Development continues.

Key PubMed References

435 PubMed references · showing top 25 by relevance

View all on PubMed

Elamipretide: First Approval.

Human Study

Shirley M · Drugs · 2026

PMID: 41335372

Contemporary insights into elamipretide's mitochondrial mechanism of action and therapeutic effects.

Review

Sabbah HN, Alder NN, Sparagna GC, et al. · Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2025

PMID: 40294492

Expanded-access use of elamipretide in a newborn with Barth syndrome: a case report.

Review

Ortmann L, Velasco D, Cole J · European heart journal. Case reports · 2025

PMID: 39917770

Elamipretide: A Review of Its Structure, Mechanism of Action, and Therapeutic Potential.

Review

Tung C, Varzideh F, Farroni E, et al. · International journal of molecular sciences · 2025

PMID: 39940712

Effect of Elamipretide on the Vitrification of Mouse Ovarian Tissue by Freezing.

Animal Study

Yao X, Lu Q, Wu Y, et al. · Biopreservation and biobanking · 2024

PMID: 38648553

Anecdotes & Sentiment

Public discussion, not clinical evidence

This section summarizes what people are talking about in public sources. It can be useful for spotting questions, hype cycles, and recurring concerns, but it is separate from the evidence sections above.

No curated public-discussion themes are live for SS-31 (Elamipretide) yet.

Side Effects & Safety

**Common Side Effects (from clinical trials):** - Injection site reactions (pain, redness, swelling) - Headache - Nausea (mild) - Generally well-tolerated in clinical trials at doses up to 50 mg/day **Rare but Serious Risks:** - Limited long-term safety data beyond clinical trial durations - Theoretical concern: altering mitochondrial function could have unforeseen effects with chronic use > Contraindications: Not established due to limited data.

Common Side Effects (from clinical trials):

Injection site reactions (pain, redness, swelling)
Headache
Nausea (mild)
Generally well-tolerated in clinical trials at doses up to 50 mg/day

Rare but Serious Risks:

Limited long-term safety data beyond clinical trial durations
Theoretical concern: altering mitochondrial function could have unforeseen effects with chronic use

> Contraindications: Not established due to limited data. Use caution in individuals with known mitochondrial disorders (could alter disease progression unpredictably). Not recommended during pregnancy/breastfeeding.

Known Interactions

No curated interaction entry is live for SS-31 (Elamipretide) yet.

Until the interaction table is fully populated, use the interaction checker and related peptides below to explore adjacent compounds and likely research pairings.

Comparison Pages

Comparison pages

All

No comparison page is linked yet.

Frequently Asked Questions

Research Disclaimer

This page is for research and educational purposes only. The information presented is based on published scientific literature and does not constitute medical advice, diagnosis, or treatment recommendations. Regulatory status can vary by compound, formulation, indication, and jurisdiction. Check official labeling, registry records, and qualified professional guidance before making any health-related decision. The studies referenced are linked to their original PubMed sources for verification.