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FDA Approved 11 views

SS-31 (Elamipretide)

Mitochondrial-targeting peptide for cellular energy optimization (Elamipretide)

SS-31 (Elamipretide) molecular structure

Overview

SS-31 (Elamipretide) is a cutting-edge peptide that targets the "power plants" of your cells — the mitochondria. Unlike typical antioxidants that mop up damage after it happens, SS-31 prevents damage at the source. **Why mitochondria matter:** Mitochondria produce over 90% of your cellular energy. When they dysfunction — which happens increasingly with age and disease — cells can't work properly, leading to fatigue, organ decline, and accelerated aging. **How SS-31 works:** SS-31 concentrates in the inner mitochondrial membrane where it stabilizes cardiolipin, a crucial molecule for energy production. This improves efficiency and dramatically reduces the "exhaust" (reactive oxygen species) that damages cells. **What the research shows:** • Enhances cellular energy production (ATP) • Protects heart, kidney, and brain tissue in injury models • May improve exercise capacity and reduce fatigue • Studied in clinical trials for mitochondrial diseases and heart failure • Could slow age-related functional decline **Clinical development:** Currently being studied for primary mitochondrial myopathy, heart failure, and age-related conditions. **Important to know:** SS-31 is not yet FDA-approved. Clinical trials are ongoing for various conditions involving mitochondrial dysfunction. --- **Sources:** Szeto HH, et al. (2014) British Journal of Pharmacology | Karaa A, et al. (2018) Neurology | Sabbah HN, et al. (2016) Circulation: Heart Failure

Last reviewed: 2026-08-18

Identity & Aliases

Also known as

SS-31ElamipretideBendaviaMTP-131Forzinity (approved brand)

Status: Research compound - Mitochondrial peptide

CAS736992-21-5
PubChem11299052

Full composition (formula, molecular weight, sequence) in Quick Facts →

Research Areas

Mitochondrial medicineBarth syndromeHeart failureMitochondrial myopathyIschemia-reperfusion injury

Available Evidence

Human

Elamipretide received FDA accelerated approval (Sept 2025) as the first treatment for Barth syndrome (brand name Forzinity) based on the TAZPOWER trial and supporting data. Earlier trials in heart failure (Circ Heart Fail 2018, PMID 29282381) and primary mitochondrial myopathy (Karaa et al., Neurology 2018) reported safety with mixed efficacy signals.

Animal

Preclinical models show SS-31 concentrates in the inner mitochondrial membrane, binds cardiolipin, reduces reactive oxygen species, and improves mitochondrial energetics in cardiac ischemia-reperfusion, renal, and neurodegenerative injury models.

In Vitro

Cell assays demonstrate cardiolipin stabilization, restoration of cristae structure, improved ATP production, and reduced oxidative stress in stressed mitochondria.

Uncertain

Accelerated approval is conditional on confirmatory trials; indications beyond Barth syndrome (heart failure, myopathy, aging) are not approved, and efficacy in those settings remains unproven or mixed.

Key Studies & Findings

3 studies
Clinical2025

FDA granted accelerated approval to elamipretide (Forzinity) as the first treatment for Barth syndrome.

Clinical2018

A randomized, placebo-controlled trial of elamipretide in heart failure with reduced ejection fraction demonstrated safety and favorable signals on cardiac structure/function but did not meet all primary endpoints.

Benefits & Effects

8 documented

Mitochondrial protection

anecdotal

Mental health support

anecdotal

Anti-aging effects

anecdotal

Cellular energy enhancement

anecdotal

Neuroprotection

anecdotal

Cognitive support

anecdotal

Mitochondrial Protection: Stabilizes cardiolipin, enhances ATP

clinical

Cardiac Function: LV volume improvements

clinical

Side Effects & Safety

7 reported

Mild-Moderate side effect

Mild-ModerateVery common (80-86%) Reversible

Onset: Immediately-hours

Management: Rotate injection sites

Dose-dependent

Mild side effect

MildRare (1/21 led to withdrawal) Reversible

Onset: During treatment

Management: Discontinue if severe; resolves

Mild-Moderate side effect

Mild-Moderate57% mild, 43% moderate Reversible

Onset: Throughout

Management: Supportive care

Headache

MildUncommon

Rare systemic effects

SevereRare

Injection site reactions

MildUncommon

Dizziness

MildUncommon

Limitations & Open Questions

Approval is accelerated (requires confirmatory trials); trials in heart failure and mitochondrial myopathy showed mixed results; long-term outcomes data are limited; use for general 'mitochondrial health' or anti-aging is off-label and unsupported.

Pharmacology

Small mitochondrial-targeting tetrapeptide (D-Arg-dimethylTyr-Lys-Phe-NH2); administered subcutaneously (Forzinity); selectively partitions into the inner mitochondrial membrane, binds cardiolipin, stabilizes cristae, and improves electron transport efficiency while reducing ROS. Half-life is short, requiring frequent dosing.

Reported Research Dosing

Reported values from research literature and community protocols. Educational reference only — not a dosing recommendation or medical advice.

40 mg Daily

Route: SC
Half-life: Variable

Research Protocols

General Mitochondrial Support

Dose
5-10mg
Frequency
Once daily
Route
Subcutaneous

Athletic Performance

Dose
10-20mg
Frequency
Once daily pre-workout
Route
Subcutaneous

Clinical Protocols

Dose
40mg
Frequency
Once daily
Route
Subcutaneous or IV

Acute Cardioprotection

Dose
0.25mg/kg/hr
Frequency
Continuous infusion
Route
Intravenous

Research protocols are for educational purposes only. Always consult qualified medical professionals.

Frequently Asked Questions

Is SS-31 the same as the FDA-approved Forzinity?

Yes - Forzinity is the approved brand of elamipretide (SS-31), granted accelerated approval in 2025 specifically for Barth syndrome.

Can SS-31 be used for general anti-aging?

No approved indication supports that; approved use is limited to Barth syndrome, with confirmatory trials pending. Other uses are investigational.

Research Citations

2
Innovative technologies for the treatment of dry age-related macular degeneration (AMD) - modern therapeutic perspectives and their future.

Przemysław Ciszewski, Alicja Drelichowska, Damian Pikor, Emilia Wiśniewska, Michał Azierski (2025)

4
SS-31, a Mitochondria-Targeting Peptide, Ameliorates Kidney Disease.

Zhu Y, Luo M, Bai X, Li J, Nie P, Li B, Luo P (2022)

5
Elamipretide (SS-31) improves mitochondrial dysfunction, synaptic and memory impairment induced by lipopolysaccharide in mice.

Zhao W, Xu Z, Cao J, Fu Q, Wu Y, Zhang X, Long Y, Zhang X, Yang Y, Li Y, Mi W (2019)

+ 48 more citations

Related Resources

Quick Facts

Formula

C32H49N9O5

Molecular Weight

639.79

Mechanism

Mitochondrial-targeted peptide for cellular energy

Safety Information

Research compound only. Limited human safety data available.

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