Elamipretide (SS-31)
Peptide ·Exploratory record · not publication-reviewed ·Updated July 13, 2026
Elamipretide is a mitochondria-targeting tetrapeptide that binds cardiolipin on the inner mitochondrial membrane. As of September 19, 2025, Forzinity (elamipretide) is FDA-approved under accelerated approval to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg; all wellness, longevity, myopathy, heart failure, and fatigue uses remain investigational or off-label. It should be handled as a prescription specialty drug where approved, not a research peptide supplement.
Exploratory record, not a reviewed medical publication.
See the editorial and medical-review policies for the publication gate.
This safety record covers a controlled, investigational, or otherwise out-of-scope substance. It remains available for reference, but it is not part of NutriStack's public supplement publication set.
What the research says.
A quick, data-only summary. The full evidence, dosing, and sources are below.
Elamipretide (SS-31) is a peptide most often used for fda accelerated approval for barth syndrome muscle strength in patients weighing at least 30 kg, with confirmatory evidence still important, cardiolipin-binding mitochondrial mechanism, studied in primary mitochondrial myopathy and other mitochondrial disorders. NutriStack rates the overall evidence as moderate. A typical adult dose is Forzinity label: 40 mg subcutaneously once daily for indicated Barth syndrome patients; no approved wellness dose, commonly taken as fda-approved forzinity under specialist prescription for barth syndrome; avoid research products. This profile indexes 3 sources.
- FDA accelerated approval for Barth syndrome muscle strength in patients weighing at least 30 kg, with confirmatory evidence still important3
- Cardiolipin-binding mitochondrial mechanism1,2
- Studied in primary mitochondrial myopathy and other mitochondrial disorders1,2
- Off-label longevity use is not established
The bottom line
Evidence rating moderate. Most-documented uses: fda accelerated approval for barth syndrome muscle strength in patients weighing at least 30 kg, with confirmatory evidence still important, cardiolipin-binding mitochondrial mechanism, studied in primary mitochondrial myopathy and other mitochondrial disorders. 3 sources indexed (2020–2025), with 0 interaction records on file.
How it works, mechanistically.
Core mechanism
Elamipretide localizes to the inner mitochondrial membrane and associates with cardiolipin, helping stabilize cristae structure, electron transport, and ATP production while reducing pathologic reactive oxygen species in models. Clinical trial results have varied by disease: Barth syndrome received accelerated approval based on muscle-strength data, while primary mitochondrial myopathy phase 3 endpoints were not met. Injection-site reactions are common.1,2
Dosing & protocol.
Approved product is subcutaneous injection. Oral research products are not established substitutes.
What it actually costs.
Real-world pricing across three quality tiers. Assumes FDA-approved specialty injection.
Specialty-drug costs and coverage vary widely; research products are not substitutes for Forzinity. Updated 2026-06-04.
Full safety detail.
Side effects
- Injection-site pain
- Injection-site erythema or pruritus
- Nausea
- Headache
- Dizziness
- Hypersensitivity reaction
- Unknown long-term off-label safety
Contraindications
- Use outside FDA-approved Barth syndrome indication without specialist oversight3
- Known hypersensitivity to elamipretide or excipients1,2
- Pregnancy and breastfeeding without specialist review
- Research-grade or compounded products substituted for Forzinity
- Mitochondrial symptoms without diagnostic evaluation1,2
Sources, by evidence tier.
Numbered references. Citations throughout the page link here.
Randomized controlled trials
2- 1Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical TrialKaraa A et al. · Neurology · 2023
Primary endpoints were not met
- 2A randomized crossover trial of elamipretide in adults with primary mitochondrial myopathyKaraa A et al. · Journal of Cachexia, Sarcopenia and Muscle · 2020
Short-term crossover data suggested signals
Reference material
1- 3Drug Trials Snapshots: ForzinityUS Food and Drug Administration · FDA Drug Trials Snapshots · 2025
Approved September 19, 2025 under accelerated approval; the initial randomized portion did not show superiority on primary endpoints.
Common questions.
Quick answers about Elamipretide (SS-31), drawn from the data on this page.
What is Elamipretide (SS-31)?
Elamipretide is a mitochondria-targeting tetrapeptide that binds cardiolipin on the inner mitochondrial membrane. As of September 19, 2025, Forzinity (elamipretide) is FDA-approved under accelerated approval to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg; all wellness, longevity, myopathy, heart failure, and fatigue uses remain investigational or off-label. It should be handled as a prescription specialty drug where approved, not a research peptide supplement.
What is Elamipretide (SS-31) used for?
Commonly cited benefits of Elamipretide (SS-31) include: FDA accelerated approval for Barth syndrome muscle strength in patients weighing at least 30 kg, with confirmatory evidence still important; Cardiolipin-binding mitochondrial mechanism; Studied in primary mitochondrial myopathy and other mitochondrial disorders; Off-label longevity use is not established. NutriStack rates the overall evidence as moderate.
What is a typical dose of Elamipretide (SS-31)?
A typical adult dose of Elamipretide (SS-31) is Forzinity label: 40 mg subcutaneously once daily for indicated Barth syndrome patients; no approved wellness dose. The commonly recommended form is FDA-approved Forzinity under specialist prescription for Barth syndrome; avoid research products. These are general ranges, not personalized advice; confirm the right dose with a clinician.
What are the side effects of Elamipretide (SS-31)?
Reported side effects include injection-site pain, injection-site erythema or pruritus, nausea, headache, dizziness, hypersensitivity reaction. This is educational information; check with a healthcare professional before use.
How strong is the evidence for Elamipretide (SS-31)?
NutriStack rates this as Moderate, meaning several aligned RCTs or one large RCT plus supporting reviews. Full tier criteria are at https://nutristackapp.com/methodology/evidence-tiers.
Use this with your stack
Elamipretide (SS-31) in NutriStack.
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