Elamipretide (Forzinity/SS-31)

Peptide

Elamipretide is a mitochondria-targeting tetrapeptide (D-Arg-Dmt-Lys-Phe-NH2) that binds cardiolipin to stabilize cristae structure and improve ATP production. FDA-approved September 2025 for Barth syndrome - the first FDA-approved therapy for any mitochondrial disease. TAZPOWER trial: 96m improvement in 6MWT (P=0.003), >45% improvement in knee extensor strength at 168 weeks. Also studied in heart failure (PROGRESS-HF) and STEMI (EMBRACE-STEMI) with mixed results.

Quick Answer

What it is

Key findings

Grade A: 6-Minute Walk Test (Barth Syndrome) (Barth Syndrome)
Grade A: Muscle Strength (Barth Syndrome) (Barth Syndrome)
Grade A: Safety and Tolerability (Barth Syndrome)

Safety

TAZPOWER 168-week OLE: Well tolerated with injection-site reactions as most common adverse event.

⚠️ Research Notice

This peptide information is for educational and research purposes only. Peptides may not be FDA-approved for human use and may only be legally available for research purposes. Consult qualified healthcare professionals before considering any peptide compounds.

ℹ️ Quick Facts: Elamipretide (Forzinity/SS-31)

Quick Facts: Elamipretide (Forzinity/SS-31)

Best Evidence:Grade A
Conditions Studied:3
Research Outcomes:22
Grade A Findings:3
Grade B Findings:3
Key Effect:Barth Syndrome

C15

3 conditions · 22 outcomes

Detailed Outcomes

6-Minute Walk Test (Barth Syndrome)

TAZPOWER 168-week OLE (n=10): Cumulative 96.1 meter improvement in 6MWT from baseline (P=0.003). Significant improvements maintained at all OLE timepoints. Led to FDA accelerated approval in 2025.

large↑Improves

Muscle Strength (Barth Syndrome)

TAZPOWER trial: Knee extensor muscle strength improved by >45% with elamipretide treatment. Significantly correlated with improvement in 6MWT. First approved therapy for Barth syndrome.

large↑Improves

Safety and Tolerability

TAZPOWER 168-week OLE: Well tolerated with injection-site reactions as most common adverse event. No serious safety signals. FDA granted Orphan Drug, Fast Track, Priority Review, and Rare Pediatric Disease designations.

large↑Improves

Cardiac Function (Barth Syndrome)

TAZPOWER trial demonstrated improvements in cardiac function in Barth syndrome cardiomyopathy. Elamipretide stabilizes mitochondrial cristae and improves bioenergetics in cardiomyocytes. Long-term safety data favorable over 168 weeks.

moderate↑Improves

LV End-Systolic Volume (HFrEF)

PROGRESS-HF Phase 2 (n=71): Elamipretide 4mg or 40mg daily x28 days did not improve LVESV vs placebo in stable HFrEF patients. Well tolerated but failed to meet primary endpoint.

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Infarct Size (STEMI)

EMBRACE-STEMI Phase 2a trial: Elamipretide not associated with decrease in myocardial infarct size in anterior STEMI patients. However, reduced incidence of heart failure within 24h of PCI (exploratory endpoint).

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