FDA granted accelerated approval to elamipretide (Forzinity) as the first treatment for Barth syndrome.
SS-31 (Elamipretide)
Mitochondrial-targeting peptide for cellular energy optimization (Elamipretide)

Overview
Last reviewed: 2026-08-18
Identity & Aliases
Also known as
Status: Research compound - Mitochondrial peptide
Full composition (formula, molecular weight, sequence) in Quick Facts →
Research Areas
Available Evidence
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.
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.
Cell assays demonstrate cardiolipin stabilization, restoration of cristae structure, improved ATP production, and reduced oxidative stress in stressed mitochondria.
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
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.
A phase 2/3 randomized clinical trial followed by open-label extension (TAZPOWER) evaluated elamipretide in Barth syndrome and contributed efficacy/safety data supporting its approval.
Benefits & Effects
Side Effects & Safety
Mild-Moderate side effect
Onset: Immediately-hours
Management: Rotate injection sites
Dose-dependent
Mild side effect
Onset: During treatment
Management: Discontinue if severe; resolves
Mild-Moderate side effect
Onset: Throughout
Management: Supportive care
Limitations & Open Questions
Pharmacology
Reported Research Dosing
Reported values from research literature and community protocols. Educational reference only — not a dosing recommendation or medical advice.
40 mg Daily
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
Prisha S Patel, Navjot S Pabla, Amandeep Bajwa (2025)
Przemysław Ciszewski, Alicja Drelichowska, Damian Pikor, Emilia Wiśniewska, Michał Azierski (2025)
Zhu Y, Luo M, Bai X, Li J, Nie P, Li B, Luo P (2022)
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.
Citations
53Prisha S Patel, Navjot S Pabla, Amandeep Bajwa (2025)
Przemysław Ciszewski, Alicja Drelichowska, Damian Pikor, Emilia Wiśniewska, Michał Azierski (2025)
Zhu Y, Luo M, Bai X, Li J, Nie P, Li B, Luo P (2022)
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