SS-31 is now an approved drug ingredient under a specific name
SS-31, also called elamipretide, is a mitochondria-targeted tetrapeptide. In September 2025 FDA granted accelerated approval to the prescription product Forzinity (elamipretide). That approval is narrow and product-specific; it does not apply to generic “SS-31” research vials, wellness use, or other mitochondrial disorders.[1]
The approved indication is Barth syndrome only
Forzinity is indicated to improve muscle strength in adults and pediatric patients with Barth syndrome who weigh at least 30 kg.[2] Approval used the accelerated pathway and was based on improvement in knee-extensor muscle strength as an intermediate clinical endpoint. Continued approval may depend on a confirmatory trial that verifies clinical benefit.[2][3]
Evidence does not generalize across mitochondrial diseases
In the 218-participant MMPOWER-3 trial, elamipretide did not improve the six-minute walk distance or fatigue at 24 weeks in primary mitochondrial myopathy.[4] In the much smaller 12-person randomized Barth syndrome crossover trial, neither primary endpoint was met during the blinded phase; improvements appeared during the open-label extension.[5]
These mixed, disease-specific results show why an approval for Barth syndrome cannot be reframed as evidence for energy, exercise performance, anti-aging, recovery, heart disease, or general mitochondrial support.
Product-specific safety and use
Forzinity has an FDA-reviewed formulation, dose, storage instructions, contraindications, warnings, and adverse-reaction information.[2] Those instructions belong only to the approved product and eligible Barth syndrome patients under clinical care. A research powder does not inherit its identity, purity, concentration, stability, or safety evidence.
Regulatory status
Elamipretide is FDA-approved only as Forzinity for the labeled Barth syndrome population. Other indications remain unapproved or investigational. Teloryx does not convert the product label or clinical-trial regimens into self-use instructions for research vials.