Rankings / Mitochondria & Cellular Energy
SS-31 (elamipretide)
Mitochondria & Cellular Energy · Mitochondrial peptide
Tier B+
Bottom line
Read Off Label grades SS-31 (elamipretide) as B+ (7.1/10) based on moderate evidence, moderate benefit magnitude, and a low-risk safety profile.
Specifically targets dysfunctional mitochondria (binds cardiolipin to stabilize cristae) — novel MOA.
Typical use: 40 mg SC daily in Phase 2/3 trials — Rx in US — FDA accelerated approval Sept 2025 as FORZINITY (elamipretide) for Barth syndrome (first approved mitochondria-targeted therapeutic); off-label/investigational for mitochondrial-energy and longevity uses.
What this is
Specifically targets dysfunctional mitochondria (binds cardiolipin to stabilize cristae) — novel MOA. FDA granted accelerated approval on Sept 19, 2025 (FORZINITY) for Barth syndrome in patients >=30 kg — the first approved mitochondria-targeted therapeutic, though an ultra-rare indication (~150 US patients). Earlier data in primary mitochondrial myopathy and heart failure with preserved EF were mixed; the mitochondrial-energy/longevity use readers care about remains off-label and unproven. Represents the emerging mitochondria-targeted therapeutic class.
Mechanism
Tetrapeptide that selectively targets cardiolipin in inner mitochondrial membrane; stabilizes cristae; reduces ROS; improves ETC efficiency
Dose & route
40 mg SC daily in Phase 2/3 trials
Citations
- https://pubmed.ncbi.nlm.nih.gov/33876242/
- https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.050756
- https://pmc.ncbi.nlm.nih.gov/articles/PMC7292817/
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Common questions
- Does SS-31 (elamipretide) work?
- Read Off Label rates the evidence for SS-31 (elamipretide) as Moderate and the benefit magnitude as moderate, producing an overall grade of B+ (7.1/10). Specifically targets dysfunctional mitochondria (binds cardiolipin to stabilize cristae) — novel MOA.
- Is SS-31 (elamipretide) safe?
- SS-31 (elamipretide) has a low risk profile in published human data. Legal status: Rx in US — FDA accelerated approval Sept 2025 as FORZINITY (elamipretide) for Barth syndrome (first approved mitochondria-targeted therapeutic); off-label/investigational for mitochondrial-energy and longevity uses. This is not medical advice — see the disclaimer.
- What is the typical dose for SS-31 (elamipretide)?
- 40 mg SC daily in Phase 2/3 trials
- How does SS-31 (elamipretide) work?
- Tetrapeptide that selectively targets cardiolipin in inner mitochondrial membrane; stabilizes cristae; reduces ROS; improves ETC efficiency
This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.