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Elamipretide

SS-31 · MTP-131 · Bendavia · mitochondria-targeting tetrapeptide

Overview

Elamipretide (SS-31) is an investigational tetrapeptide from Stealth BioTherapeutics that concentrates in the inner mitochondrial membrane, binds cardiolipin and aims to improve cellular energy production. It is in genuine clinical trials for rare mitochondrial diseases, but results are mixed and it is not approved. The consumer "anti-ageing/energy" framing runs well ahead of the evidence.

01 What is Elamipretide?

In plain English.

Elamipretide is an experimental injectable drug, made of just four [amino acids](/glossary "Amino acid: The building blocks of proteins. A peptide is a short chain of them linked together."), developed by Stealth BioTherapeutics. It is designed to home in on the mitochondria — the tiny structures inside your cells that act as power plants, turning food and oxygen into usable energy. The idea is that in diseases where mitochondria fail, propping up their energy output could help. In the biohacker and longevity world it is often sold (as SS-31) as an "anti-ageing" or "cellular energy" booster, but that framing goes far beyond what the actual trials have shown.

⏱ Half-life
~2–3 hours (short)
☉ Route
Subcutaneous injection
⚖ Evidence
Mixed; several missed endpoints
📚 Studies
5 referenced

It is investigational, meaning it is not an approved prescription medicine anywhere in the world. The only legitimate way to receive it is enrolment in a registered clinical trial. Vials sold online as "SS-31" are unregulated research chemicals: their contents, purity, sterility and dose cannot be verified, and they are not the clinical-grade drug used in trials.

02 How it works

The simple version, then the science.

Elamipretide targets the cell's power plants — the mitochondria — to help them make energy more efficiently. In cells that are struggling because their mitochondria are damaged or under stress, the peptide is meant to stabilise the machinery that produces energy, so the cell can keep working. That is the theory behind testing it in diseases where failing mitochondria are the core problem, such as inherited mitochondrial myopathies and Barth syndrome.

Go deeper · the proposed mechanism

Elamipretide is a cell-permeable, aromatic-cationic tetrapeptide (D-Arg-2',6'-dimethyl-Tyr-Lys-Phe-NH2) of the Szeto–Schiller (SS) peptide class. It accumulates several-hundred-fold in the inner mitochondrial membrane, where it binds the phospholipid cardiolipin. By associating with cardiolipin it is thought to stabilise cristae architecture and the supercomplexes of the electron transport chain, improve oxidative phosphorylation and reduce reactive-oxygen-species leakage and cytochrome-c peroxidase activity. Unlike antioxidants that scavenge free radicals, its proposed action is structural — preserving the membrane environment in which efficient ATP synthesis occurs.

03 What it's used for

Each use graded by how strong the evidence actually is.

  • Moderate
    Primary mitochondrial myopathy🔬 The lead clinical indication. The MMPOWER-3 phase 3 trial (Neurology, 2024) tested subcutaneous elamipretide in primary mitochondrial myopathy and missed its co-primary endpoints (six-minute walk distance and a symptom score). Earlier signals from MMPOWER did not translate into a clear phase 3 benefit. Development has continued in narrower sub-populations.
  • Moderate
    Barth syndrome🔬 A rare X-linked cardiolipin disorder. The TAZPOWER crossover trial did not meet its primary endpoints over the blinded period, but an open-label extension reported improvements in muscle and cardiac measures, which became the basis for ongoing FDA interactions in this ultra-rare indication.
  • Limited
    Heart failure🔬 Originally developed (as Bendavia / MTP-131) for ischaemia-reperfusion injury and heart failure. Early-phase cardiovascular studies, including work in heart failure with reduced ejection fraction, were largely neutral and this line of development was not advanced to approval.
  • Limited
    Dry AMD / geographic atrophy🔬 The ReCLAIM and ReCLAIM-2 studies evaluated elamipretide in dry age-related macular degeneration and geographic atrophy. Results were mixed, with some retinal-function signals but no clear win on the primary endpoint in the controlled phase 2 work.
  • Anecdotal
    General "energy" / "anti-ageing" use💬 Sold by online peptide vendors as SS-31 for fatigue, longevity, fitness recovery and "mitochondrial health" in healthy people. There is no clinical trial evidence supporting these uses; the human programme is in serious rare disease, not anti-ageing, and the consumer framing is not backed by data.
Elamipretide is investigational. It is not an approved medicine in the UK, US or EU. Its real research is in rare mitochondrial disease — not as a general "energy" or "anti-ageing" supplement. Several pivotal trials missed their primary endpoints.

04 What the evidence says

This is an honest "mixed" picture, not a success story dressed up as one. Elamipretide has a genuine, serious clinical programme — that is what separates it from most "longevity" peptides — but its pivotal trials have largely underdelivered. In primary mitochondrial myopathy, the phase 2 MMPOWER signal did not hold up: the phase 3 MMPOWER-3 trial (published in Neurology in 2024) failed to meet its co-primary endpoints. In Barth syndrome, the TAZPOWER crossover did not meet its primary endpoint in the blinded phase, though an open-label extension reported functional gains that have kept the ultra-rare programme alive in FDA discussions. The cardiovascular work (as Bendavia, for ischaemia-reperfusion and heart failure) was broadly neutral and was not advanced. The ReCLAIM eye studies in dry AMD / geographic atrophy were similarly mixed. The fair summary: real human data exist, the mechanism is biologically plausible and the drug is generally well tolerated, but efficacy is unsettled and it is approved nowhere. The popular "reverses ageing / boosts your mitochondria" story is built on cell and animal work and biohacker enthusiasm, not on positive pivotal human trials.

05 Dosing & administration

Reported in the literature, information not advice.

For context only — there is no approved elamipretide product and no validated outpatient protocol. Trials have used once-daily subcutaneous injection (commonly cited around 40 mg/day in the mitochondrial myopathy programme), with dosing administered under clinical supervision. None of this constitutes instructions: self-injecting an unregulated "SS-31" product bought online is outside established medicine, the dose and contents cannot be verified, and a forum protocol cannot make that safe.

06 Side effects & safety

In the clinical trials run to date, elamipretide has generally been reasonably well tolerated, which is part of why development has continued despite efficacy misses. The most commonly reported adverse events are injection-site reactions (redness, itching, swelling at the site of subcutaneous administration). Beyond that, the trial safety profile has not flagged major new concerns, but this is still an investigational drug: there is no long-term, large-population safety data, and effects over years of use are unknown. Anything bought as "SS-31" from a research-chemical vendor carries the separate, larger risk of an unregulated, unverified product — unknown purity, dose, sterility and no clinical oversight. People who are pregnant or breastfeeding, and anyone with significant medical conditions or on other medication, would in any case fall outside the population that has been studied.

Legal status: Investigational only. Not approved by the FDA, MHRA or EMA. Legitimate access is via clinical trial enrolment, not online "SS-31" vendors.

07 Can you buy it?

Investigational, not approved or sold as a medicine anywhere.

Elamipretide is investigational. It is not approved or sold as a medicine in any country, so there is no legitimate way to buy it. The only legitimate way to receive it is by enrolling in a registered clinical trial.
ClinicalTrials.gov
Search for currently recruiting Elamipretide trials. Participation is medically supervised and free of charge.
Registered trialsMedically supervised
Visit ↗
Disclosure: Vials sold online as "Elamipretide" are unregulated research chemicals of unverified identity, purity and dose, not the trial drug. There is no approved product to buy, and self-sourcing an investigational compound is unsafe.

09 Clinical studies & research

Primary sources. Read the science yourself.

Elamipretide in primary mitochondrial myopathy (MMPOWER-3, phase 3)
Neurology · 2024 Human · Phase 3 RCT
Pivotal randomised, double-blind, placebo-controlled phase 3 trial of subcutaneous elamipretide in adults with primary mitochondrial myopathy. The trial did not meet its co-primary endpoints (six-minute walk distance and a patient-reported fatigue/symptom measure), tempering the earlier phase 2 signal. View on PubMed →
Elamipretide in primary mitochondrial myopathy (MMPOWER phase 2)
PubMed (Karaa A et al.) · 2018 Human · Phase 2 RCT
Earlier phase 2 study evaluating short-term subcutaneous and intravenous elamipretide in primary mitochondrial myopathy. Reported dose-dependent signals on the six-minute walk test that motivated the larger phase 3 programme but were not subsequently confirmed. View on PubMed →
Elamipretide in Barth syndrome (TAZPOWER)
PubMed · 2021 Human · Phase 2/3 crossover
Randomised, double-blind, placebo-controlled crossover trial of elamipretide in Barth syndrome, an ultra-rare cardiolipin disorder. The blinded period did not meet its primary endpoints, but an open-label extension reported improvements in muscle strength and cardiac measures. View on PubMed →
Elamipretide in dry AMD / geographic atrophy (ReCLAIM)
PubMed · 2020 Human · Phase 2
The ReCLAIM and ReCLAIM-2 studies evaluated subcutaneous elamipretide in dry age-related macular degeneration with geographic atrophy. Results were mixed, with some retinal-function signals but no clear win on the controlled primary endpoint. View on PubMed →
SS-31 / elamipretide mechanism: cardiolipin binding and mitochondrial function
PubMed (Szeto HH and colleagues) · 2014 Preclinical · Mechanism review
Body of preclinical work characterising the SS-peptide class. Describes accumulation in the inner mitochondrial membrane, binding to cardiolipin, stabilisation of cristae and electron-transport-chain function, and reduction of reactive oxygen species — the mechanistic basis for the clinical programme. View on PubMed →

10 Frequently asked questions

What is SS-31?
SS-31 is another name for elamipretide (also called MTP-131 or Bendavia), a small four-amino-acid peptide developed by Stealth BioTherapeutics. It targets the mitochondria — the cell's energy-producing structures — by binding a membrane lipid called cardiolipin. It is investigational and not approved as a medicine anywhere.
Does elamipretide reverse ageing?
No — there is no clinical evidence that elamipretide reverses ageing. The "anti-ageing" and "cellular energy" framing comes from cell and animal studies plus biohacker marketing, not from human trials. Its actual clinical programme is in serious rare mitochondrial diseases, and several of those pivotal trials missed their primary endpoints.
Is elamipretide approved?
No. Elamipretide is not approved as a medicine in the UK, US, EU or anywhere else. It remains investigational, studied mainly in rare-disease indications such as primary mitochondrial myopathy and Barth syndrome, with ongoing FDA interactions in the ultra-rare setting.
Did the mitochondrial myopathy trials work?
Not clearly. An early phase 2 study (MMPOWER) produced an encouraging signal on walking distance, but the larger phase 3 trial (MMPOWER-3, published in Neurology in 2024) did not meet its co-primary endpoints. That is why elamipretide is graded as mixed evidence rather than a proven therapy.
How does it work?
Elamipretide concentrates in the inner membrane of the mitochondria and binds cardiolipin, a key structural lipid there. By stabilising that membrane it is thought to support the electron transport chain and more efficient energy (ATP) production, and to reduce harmful reactive oxygen species — a structural rather than antioxidant mechanism.
Can I buy SS-31 / elamipretide online?
You can find vials labelled "SS-31" or "elamipretide" from research-chemical vendors, but they are not selling an approved medicine — none exists. These are unregulated preparations with no verified purity, dose or sterility. The only legitimate route to clinical-grade elamipretide is enrolment in a registered clinical trial.
Is elamipretide banned in sport?
Elamipretide is not named individually on the WADA Prohibited List, but as an unapproved investigational compound it is captured by category S0 ("Non-Approved Substances"), which prohibits any pharmacological substance not currently approved by a governmental regulatory authority. In tested sport, treat it as banned at all times.
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