{
  "schemaVersion": "2.1",
  "datasetVersion": "2026-09-11.1",
  "generatedAt": "2026-09-11",
  "reviewStatus": "Editorial source review is complete. This edition has not been independently medically reviewed.",
  "editorialBoundary": "Source-checked educational summaries. Topics require evidence and editorial review. This dataset is not a personal treatment plan.",
  "citation": "When you cite a record, include The Peptide Field, its canonicalPath, this dataset version, and every source used for the claim.",
  "reuse": "This endpoint grants no additional reuse license. Keep the verdict, scope, evidence basis, review date, and source links together. Do not present a record as medical advice or medical review.",
  "changeLogPath": "/corrections#correction-ledger",
  "contactPath": "/corrections",
  "dataset": "peptide-evidence-checker-record",
  "canonicalPath": "/peptides/ss-31",
  "canonicalUrl": "https://thepeptidefield.com/peptides/ss-31",
  "record": {
    "slug": "ss-31",
    "name": "SS-31",
    "aliases": [
      "Elamipretide",
      "MTP-131",
      "Bendavia",
      "OCUVIA",
      "RX-31",
      "SS31",
      "Szeto-Schiller peptide"
    ],
    "className": "Peptide that binds inside mitochondria",
    "family": "Longevity and cellular signaling",
    "sequenceLabel": "4 amino acids · binds to a fat inside mitochondria",
    "tier": "Established",
    "evidenceContext": "Approved human outcomes",
    "statusLine": "Forzinity has FDA accelerated approval for a narrow Barth syndrome use",
    "productContext": "FDA maps SS-31 to elamipretide, but the approval is for the specific Forzinity product and a narrow use. An online product labeled SS-31 or elamipretide is not automatically the same product as Forzinity.",
    "approvedProducts": [
      "Forzinity"
    ],
    "productRecords": [
      {
        "name": "Forzinity",
        "formulation": "Injection",
        "route": "Subcutaneous",
        "indicationScope": "To improve muscle strength in adults and children with Barth syndrome who weigh at least 30 kg.",
        "labelUrl": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215244s000lbl.pdf",
        "labelRevision": "September 2025"
      }
    ],
    "indications": [
      "Improving muscle strength in adults and children with Barth syndrome who weigh at least 30 kg"
    ],
    "profile": {
      "humanOutcomes": {
        "level": "Moderate",
        "note": "FDA approval covers one rare disease and one muscle-strength measure. Results in other conditions have been mixed, including a negative phase 3 study."
      },
      "humanPharmacology": {
        "level": "Strong",
        "note": "The FDA label describes elamipretide's four-amino-acid sequence and its binding to cardiolipin inside mitochondria."
      },
      "safetyKnowledge": {
        "level": "Moderate",
        "note": "The approved label describes injection-site reactions and serious allergic reactions. It does not define the long-term risks of every SS-31 product."
      },
      "productCertainty": {
        "level": "Strong",
        "note": "High for the named Forzinity product; limited for research material or products sold under the SS-31 name."
      }
    },
    "oneLine": "SS-31 is elamipretide. FDA approved Forzinity for one narrow use, not for anti-aging.",
    "reviewedAt": "August 30, 2026",
    "reviewedAtISO": "2026-08-30",
    "reviewHistory": [
      {
        "date": "2026-08-30",
        "note": "Reviewed FDA's Forzinity approval, label, and trial summary, the FDA identity record, and randomized human studies in Barth syndrome, primary mitochondrial myopathy, heart failure, and healthy older adults."
      }
    ],
    "whatItIs": "SS-31 is a short peptide with four amino acids. FDA's substance record maps SS-31 to elamipretide and related development names such as MTP-131 and Bendavia. Mitochondria are small parts of cells that help make energy. Elamipretide binds to a fat called cardiolipin inside them. Forzinity is the FDA-approved product name.",
    "whatWeKnow": "FDA granted Forzinity accelerated approval for adults and children with Barth syndrome who weigh at least 30 kg. The main study included 12 males age 12 or older at one U.S. site. In the randomized part, Forzinity did not beat placebo for walking distance or fatigue. FDA relied on knee-muscle strength measured during a later open-label extension, when everyone knew they received Forzinity. FDA requires another randomized study to confirm a patient benefit. In a separate 24-week study, 218 people with primary mitochondrial myopathy did not have better walking distance or fatigue with elamipretide than with placebo.",
    "whatWeDoNotKnow": "One small study in healthy older adults measured how well muscle mitochondria made energy. It did not establish more daily energy, less fatigue, longer life, or slower aging. Results in Barth syndrome do not transfer to healthy people or other diseases. FDA approval names the controlled Forzinity product. It does not show that an online SS-31 vial has the same formulation, quality controls, or evidence.",
    "antiDoping": null,
    "safetyBoundary": "The Forzinity label warns about serious allergic reactions and injection-site reactions. Those warnings apply to the approved product and do not prove that another SS-31 product is the same. This guide gives no dosing, injection, sourcing, product-use, treatment, or performance advice.",
    "relatedSlugs": [
      "mots-c",
      "epitalon",
      "cerebrolysin"
    ],
    "claims": [
      {
        "claim": "“SS-31 and elamipretide are names for the same peptide.”",
        "verdict": "Supported with scope",
        "explanation": "FDA's substance record lists SS-31 and elamipretide as synonyms. It also lists development names such as MTP-131 and Bendavia. A name match does not prove that an online vial has the same quality or product controls.",
        "category": "Mechanism and biomarkers",
        "evidenceBasis": "Regulatory or product record",
        "scope": "FDA substance identity mapping; not a quality or product-equivalence finding.",
        "sourceUrls": [
          "https://precision.fda.gov/uniisearch/srs/unii/87gwg91s09"
        ]
      },
      {
        "claim": "“Forzinity is FDA-approved for a narrow Barth syndrome use.”",
        "verdict": "Supported with scope",
        "explanation": "FDA granted accelerated approval for Forzinity to improve muscle strength in adults and children with Barth syndrome who weigh at least 30 kg. Accelerated approval uses an intermediate measure and requires a confirmatory study.",
        "category": "Approval and status",
        "evidenceBasis": "Regulatory or product record",
        "scope": "The Forzinity label and FDA approval records as reviewed August 30, 2026.",
        "sourceUrls": [
          "https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome",
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215244s000lbl.pdf",
          "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215244Orig1s000ltr.pdf"
        ]
      },
      {
        "claim": "“The randomized Forzinity study clearly improved walking and fatigue.”",
        "verdict": "Misleading",
        "explanation": "FDA says the randomized study did not show superiority to placebo on its initial walking and fatigue measures. The approval used a knee-extensor muscle-strength measure and later extension data.",
        "category": "Clinical outcomes",
        "evidenceBasis": "Randomized human outcomes",
        "scope": "The randomized Barth syndrome study and its defined measures; this does not establish a result for other diseases or products.",
        "sourceUrls": [
          "https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-forzinity",
          "https://pubmed.ncbi.nlm.nih.gov/33077895/"
        ]
      },
      {
        "claim": "“Elamipretide improved walking distance and fatigue in the large phase 3 mitochondrial-myopathy trial.”",
        "verdict": "Misleading",
        "explanation": "The 24-week MMPOWER-3 trial did not meet its main goals for six-minute walk distance or fatigue compared with placebo.",
        "category": "Clinical outcomes",
        "evidenceBasis": "Randomized human outcomes",
        "scope": "The 218 adults with genetically confirmed primary mitochondrial myopathy studied in MMPOWER-3 for 24 weeks.",
        "sourceUrls": [
          "https://pubmed.ncbi.nlm.nih.gov/37268435/"
        ]
      },
      {
        "claim": "“SS-31 is proven to increase energy, reduce fatigue, or slow aging in healthy people.”",
        "verdict": "Not established",
        "explanation": "A small healthy-aging study measured a laboratory energy measure. It did not establish better daily energy, less fatigue, longer life, or slower aging.",
        "category": "Longevity",
        "evidenceBasis": "No reliable human outcome evidence",
        "scope": "Healthy older adults in the single study reviewed; a laboratory measure is not the same as a long-term health outcome.",
        "sourceUrls": [
          "https://pubmed.ncbi.nlm.nih.gov/34264994/"
        ]
      },
      {
        "claim": "“Every product sold as SS-31 is equivalent to Forzinity.”",
        "verdict": "Misleading",
        "explanation": "Forzinity is a specific FDA-approved product. An ingredient name or research vial does not establish the same formulation, manufacturing controls, strength, sterility, or clinical evidence.",
        "category": "Product equivalence",
        "evidenceBasis": "Regulatory or product record",
        "scope": "The named Forzinity product compared with any other material sold under the SS-31 or elamipretide name.",
        "sourceUrls": [
          "https://precision.fda.gov/uniisearch/srs/unii/87gwg91s09",
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215244s000lbl.pdf"
        ]
      }
    ],
    "sources": [
      {
        "label": "FDA identity record for elamipretide and SS-31",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://precision.fda.gov/uniisearch/srs/unii/87gwg91s09",
        "kind": "Reference",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "FDA grants accelerated approval to Forzinity for Barth syndrome",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome",
        "kind": "Regulatory",
        "year": 2025,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Forzinity Drug Trials Snapshot",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-forzinity",
        "kind": "FDA review",
        "year": 2025,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Forzinity prescribing information",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215244s000lbl.pdf",
        "kind": "Drug label",
        "year": 2025,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Forzinity FDA approval letter",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215244Orig1s000ltr.pdf",
        "kind": "Regulatory",
        "year": 2025,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "TAZPOWER randomized Barth syndrome study",
        "publisher": "PubMed",
        "url": "https://pubmed.ncbi.nlm.nih.gov/33077895/",
        "kind": "Randomized trial",
        "year": 2020,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "MMPOWER-3 phase 3 mitochondrial-myopathy study",
        "publisher": "PubMed",
        "url": "https://pubmed.ncbi.nlm.nih.gov/37268435/",
        "kind": "Randomized trial",
        "year": 2023,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "MMPOWER-2 mitochondrial-myopathy study",
        "publisher": "PubMed",
        "url": "https://pubmed.ncbi.nlm.nih.gov/32096613/",
        "kind": "Randomized trial",
        "year": 2020,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "PROGRESS-HF elamipretide heart-failure study",
        "publisher": "PubMed",
        "url": "https://pubmed.ncbi.nlm.nih.gov/32068002/",
        "kind": "Randomized trial",
        "year": 2020,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Elamipretide study in healthy older adults",
        "publisher": "PubMed",
        "url": "https://pubmed.ncbi.nlm.nih.gov/34264994/",
        "kind": "Human pilot",
        "year": 2021,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "TAZPOWER clinical study record",
        "publisher": "ClinicalTrials.gov",
        "url": "https://clinicaltrials.gov/study/NCT03098797",
        "kind": "Trial registry",
        "year": 2017,
        "accessedAt": "2026-08-30"
      }
    ],
    "antiDopingReview": {
      "status": "Not assessed",
      "detail": "This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.",
      "sourceUrl": null,
      "reviewedAtISO": "2026-08-30"
    }
  }
}