Machine-assisted translation — the German original version is authoritative.
Longevity & Immune System
SS-31 (Elamipretid)
Elamipretid · Bendavia · MTP-131 · Forzinity
SS-31 (elamipretide) is a cell-permeable tetrapeptide that attaches to cardiolipin in the inner mitochondrial membrane, stabilizes the cristae structure, and supports ATP production. After years as an investigational substance (including under the name "Bendavia"), it was granted accelerated approval in the USA in 2025 as FORZINITY for the rare Barth syndrome. For other applications — heart failure, mitochondrial disorders, eye diseases — it remains under investigation.
Regulatory status
Approved · prescription-only
Approved in the USA in 2025 for Barth syndrome (FORZINITY, accelerated); remaining applications under investigation.
Drug class
Cardiolipin-binding, mitochondria-targeted tetrapeptide
Half-life (informative)
In the range of hours.
Studied in the literature
Subcutaneously in clinical studies; in the approved indication, medically supervised.
Mechanism of action
SS-31 binds cardiolipin and thereby stabilizes the cristae and the complexes of the respiratory chain. This lowers oxidative stress and increases the ATP yield — so it acts directly on the cell's energy production.
The approval is narrow so far (Barth syndrome); the remaining indications are still under investigation.
Research history
Developed at Stealth BioTherapeutics; first investigated in cardioprotective studies (as "Bendavia") and then in mitochondrial disorders. The phase-2/3 program in Barth syndrome led in 2025 to the accelerated US approval as FORZINITY.
Regulatory status by region
Accelerated approval in 2025 for the rare Barth syndrome — other indications are not approved.
No broad EU approval.
Heart failure, mitochondrial myopathy, and eye diseases are being investigated in studies.
Research areas
- Barth syndrome (approved indication)
- Primary mitochondrial myopathy
- Heart failure (HFpEF)
- Dry age-related macular degeneration; aging skeletal muscle
Documented effects (from the literature)
- Usually mild: injection-site reactions, headache.
Safety concerns & caution
- Outside Barth syndrome, efficacy is not established — several studies missed their endpoints.
- Use belongs in the respective study or approval context.
Risks of gray-market purchase
- "SS-31" research vials are not FORZINITY — purity and content are untested.
- "Anti-aging" marketing without a clinical basis.
Frequently asked questions
Is SS-31 now an approved medicine?
In the USA, since 2025, as FORZINITY — but only for the rare Barth syndrome. For "anti-aging" or sport it is neither approved nor established.
Sources
Primary and reference sources for your own reading.
Related substances
Unfamiliar terms? Look them up in the glossary or read the fundamentals.
This profile is for information and education only. It is not medical advice and deliberately contains no dosing or usage details. Decisions about use belong in a doctor’s hands.