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SS-31

Cell-permeable tetrapeptide · cardiolipin-binding · mitochondrial-targeted

EVIDENCE GRADE
B
Moderate
INN
elamipretidum
TYPE
Longevity
EU
NOT AUTHORISED
US
NOT AUTHORISED
MOLECULAR INFORMATION

Molecular information

Length
6 amino acids
Type
Cell-permeable tetrapeptide · cardiolipin-binding · mitochondrial-targeted
Amino acid sequence
D-Arg-Dmt-Lys-Phe-NH₂

SS-31 (elamipretide / MTP-131) is a cell-permeable tetrapeptide developed by Stealth BioTherapeutics. Selectively binds cardiolipin in the inner mitochondrial membrane, stabilising the electron transport chain. The most clinically-advanced mitochondrial-targeted peptide.

Status

  • Phase 3 (PROGRESS / SPIMM) ongoing for primary mitochondrial myopathy
  • Phase 2 / 3 work in Barth syndrome and dry AMD
  • FDA Complete Response Letter in primary mitochondrial myopathy (2024); resubmission pending additional data

Why we grade it B

Multiple Phase 2 trials with consistent functional-endpoint signal in mitochondrial diseases. Mechanism is well-characterised and supported by non-redundant cell-biology data. Promotion to A waits on a clean Phase 3 read-out and regulatory authorisation.

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