ML-SYS / 2026.07NON-CLINICAL RESEARCH MATERIALSORIGIN DECLARED BY LOT

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RM-MCE / Mitochondrial and cellular-energy research

SS-31

Also known as: Elamipretide · MTP-131

Approved comparator exists

Grade describes the published research on the molecule. It is not a quality score, a safety score, or a release state.

What this is

A mitochondria-targeting tetrapeptide. Elamipretide received accelerated FDA approval in 2025 for a narrow Barth-syndrome indication.

Evidence position

Grade A. The shorthand ‘SS-31’ alone does not establish that a given material is elamipretide or equivalent to the approved product. Exact identity and modification are required. Do not borrow the approved indication.

What the record does not establish

Published research about a molecule is not a test of any particular vial. Identity, purity, strength and microbiological quality are established by lot-level analytical records tied to a matched sample — not by the literature, and not by the presence of an approved comparator.

Where a lot-level record exists it is published on the evidence page and linked from the product. Where it does not exist, the record says so.

Sources

External database index

LIVE DATABASE INDEX / SEPARATE FROM CURATED EVIDENCE

Records below come directly from public scientific databases. They help find relevant material, but do not affect the evidence grade until they are matched to the molecule and added to the curated source list.

PUBMED / FOUND RECORDS

  1. Elamipretide (SS-31) improves mitochondrial dysfunction, synaptic and memory impairment induced by lipopolysaccharide in mice.Journal of neuroinflammation / 2019 Nov 20PMID 31747905 / DOI 10.1186/s12974-019-1627-9
  2. Potential Therapeutic Candidates for Age-Related Macular Degeneration (AMD).Cells / 2021 Sep 19PMID 34572131 / DOI 10.3390/cells10092483
  3. Elamipretide: A Review of Its Structure, Mechanism of Action, and Therapeutic Potential.International journal of molecular sciences / 2025 Jan 23PMID 39940712 / DOI 10.3390/ijms26030944
  4. SS-31@Fer-1 Alleviates ferroptosis in hypoxia/reoxygenation cardiomyocytes via mitochondrial targeting.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie / 2025 FebPMID 39848110 / DOI 10.1016/j.biopha.2025.117832
  5. Mitochondrial Dysfunction: The Silent Catalyst of Kidney Disease Progression.Cells / 2025 May 28PMID 40497970 / DOI 10.3390/cells14110794

CLINICALTRIALS.GOV / FOUND RECORDS

  1. Study of Healthy Aging and Physical Function With ElamipretideRECRUITING / PHASE2 / David MarcinekNCT07275424 / DIRECT intervention MATCH: elamipretide
  2. An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular DegenerationCOMPLETED / PHASE1 / Stealth BioTherapeutics Inc.NCT02848313 / DIRECT intervention MATCH: elamipretide
  3. ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)ACTIVE_NOT_RECRUITING / PHASE3 / Stealth BioTherapeutics Inc.NCT06373731 / DIRECT intervention MATCH: elamipretide
  4. A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label ExtensionTERMINATED / PHASE3 / Stealth BioTherapeutics Inc.NCT03323749 / DIRECT intervention MATCH: elamipretide
  5. A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic NeuropathyCOMPLETED / PHASE2 / Stealth BioTherapeutics Inc.NCT02693119 / DIRECT intervention MATCH: elamipretide

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