{
  "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/semax",
  "canonicalUrl": "https://thepeptidefield.com/peptides/semax",
  "record": {
    "slug": "semax",
    "name": "Semax",
    "aliases": [
      "Heptapeptide Semax"
    ],
    "className": "Seven-amino-acid peptide",
    "family": "Synthetic neuropeptides",
    "sequenceLabel": "7 amino acids · Met-Glu-His-Phe-Pro-Gly-Pro",
    "tier": "Emerging",
    "evidenceContext": "Investigational human outcomes",
    "statusLine": "Registered in Russia; no FDA-approved U.S. product or final 503A listing was identified as reviewed August 30, 2026",
    "productContext": "Semax free base and Semax acetate are distinct chemical forms. A product name does not show which form it contains or whether it matches the material studied. N-acetyl Semax amidate is a different modified substance, not a Semax alias.",
    "approvedProducts": [],
    "productRecords": [],
    "indications": [
      "Human research after stroke",
      "Small human studies of migraine and trigeminal neuralgia"
    ],
    "profile": {
      "humanOutcomes": {
        "level": "Limited",
        "note": "Small and limited human studies do not establish the focus, memory, or treatment claims made online."
      },
      "humanPharmacology": {
        "level": "Limited",
        "note": "FDA found no human pharmacokinetic studies, which measure how the body handles a drug. Human exposure and effects are not well characterized."
      },
      "safetyKnowledge": {
        "level": "Limited",
        "note": "Most safety reports were small or incomplete. FDA found no under-the-skin (subcutaneous) safety data and raised impurity, peptide-clumping (aggregation), immune-response, and bleeding concerns."
      },
      "productCertainty": {
        "level": "Unclear",
        "note": "The free base and acetate are separate forms, and the reviewed record does not show that online products match either form or the studied material."
      }
    },
    "oneLine": "Semax is a seven-amino-acid peptide. FDA has not approved it. Human studies do not prove a benefit.",
    "reviewedAt": "August 30, 2026",
    "reviewedAtISO": "2026-08-30",
    "reviewHistory": [
      {
        "date": "2026-08-30",
        "note": "Reviewed FDA's 2026 Semax briefing and advisory-committee record, FDA's substance record, human stroke and brain-scan studies, and the chemical record for N-acetyl Semax amidate."
      }
    ],
    "whatItIs": "Semax is a peptide made of seven amino acids: Met-Glu-His-Phe-Pro-Gly-Pro. FDA says it is a changed form of ACTH(4-10), which is a small part of a body hormone. Russia has registered Semax as 0.1% and 1% nose drops. FDA reviewed Semax free base and Semax acetate as separate chemical forms. N-acetyl Semax amidate is another modified substance.",
    "whatWeKnow": "FDA reviewed Semax for reduced blood flow to the brain, migraine, and severe facial pain. They found too little proof for all three uses. A 1997 stroke study compared 30 Semax-treated people with 80 people who received standard care. Its abstract did not say how large the change was. A 2018 stroke study followed 110 people, but its abstract did not show random group assignment or blinding. The 12-person migraine and 25-person facial-pain groups had no control group or blinding.",
    "whatWeDoNotKnow": "Studies do not show that Semax improves focus, memory, attention, or daily function. A 24-person study measured links on brain scans. It did not test thinking or daily function. FDA found no human study of how the body handles Semax. It found no safety data for use under the skin. Most reports gave few safety details. FDA warned about impurities, peptide clumps, immune reactions, and possible bleeding. No record shows an online product matches the form or study material.",
    "antiDoping": null,
    "safetyBoundary": "This guide does not provide dosing, route, sourcing, product-selection, or treatment advice. A Russian registration or an advisory vote does not prove U.S. approval, product quality, or personal safety.",
    "relatedSlugs": [
      "selank",
      "cerebrolysin",
      "epitalon",
      "mots-c"
    ],
    "claims": [
      {
        "claim": "“Semax is a seven-amino-acid peptide.”",
        "verdict": "Supported with scope",
        "explanation": "FDA identifies Semax as a heptapeptide with the sequence Met-Glu-His-Phe-Pro-Gly-Pro. This identifies the free-base peptide and does not make other chemical forms or products interchangeable.",
        "category": "Mechanism and biomarkers",
        "evidenceBasis": "Regulatory or product record",
        "scope": "Semax free base as identified in FDA's substance and briefing records; the acetate form is a separate chemical form.",
        "sourceUrls": [
          "https://www.fda.gov/media/193348/download",
          "https://precision.fda.gov/ginas/app/ui/substances/I5FAL2585H"
        ]
      },
      {
        "claim": "“Semax improves focus or memory, or treats ADHD.”",
        "verdict": "Not established",
        "explanation": "FDA found no supporting literature for ADHD. A 24-person study measured resting brain-scan connections, not focus, memory, attention, or daily function.",
        "category": "Clinical outcomes",
        "evidenceBasis": "No reliable human outcome evidence",
        "scope": "Focus, memory, and ADHD claims made for Semax; not a finding about the laboratory or animal literature.",
        "sourceUrls": [
          "https://www.fda.gov/media/193348/download",
          "https://pubmed.ncbi.nlm.nih.gov/30225715/"
        ]
      },
      {
        "claim": "“Semax treats stroke, migraine, or severe facial pain.”",
        "verdict": "Not established",
        "explanation": "FDA staff found insufficient evidence of effectiveness for cerebral ischemia, migraine, or trigeminal neuralgia. The two stroke studies listed here have important design and comparison limits.",
        "category": "Clinical outcomes",
        "evidenceBasis": "No reliable human outcome evidence",
        "scope": "The uses reviewed by FDA in 2026; this does not assess every possible research question.",
        "sourceUrls": [
          "https://www.fda.gov/media/193348/download",
          "https://pubmed.ncbi.nlm.nih.gov/29798983/",
          "https://pubmed.ncbi.nlm.nih.gov/11517472/"
        ]
      },
      {
        "claim": "“Semax is FDA-approved in the United States.”",
        "verdict": "Misleading",
        "explanation": "FDA says Semax free base and Semax acetate are not components of an FDA-approved drug. A drug registered in Russia does not create U.S. approval.",
        "category": "Approval and status",
        "evidenceBasis": "Regulatory or product record",
        "scope": "United States approval status as reviewed August 30, 2026.",
        "sourceUrls": [
          "https://www.fda.gov/media/193348/download",
          "https://precision.fda.gov/ginas/app/ui/substances/I5FAL2585H"
        ]
      },
      {
        "claim": "“The advisory vote added Semax to the 503A list or approved it.”",
        "verdict": "Misleading",
        "explanation": "RAPS reported an 8-5 advisory-committee vote in favor of adding Semax to the 503A list. FDA says advisory recommendations are non-binding, and the briefing says FDA had not made its final determination. No final FDA rule or listing was identified in this review.",
        "category": "Approval and status",
        "evidenceBasis": "Regulatory or product record",
        "scope": "The July 2026 advisory vote and U.S. 503A status as reviewed August 30, 2026; a recommendation is not a final FDA decision or drug approval.",
        "sourceUrls": [
          "https://www.raps.org/resource/fda-advisory-committee-backs-two-more-peptides-rejects-one-for-compounding-list.html",
          "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
          "https://www.fda.gov/media/193348/download",
          "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
          "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23"
        ]
      },
      {
        "claim": "“Semax free base, Semax acetate, and N-acetyl Semax amidate are interchangeable.”",
        "verdict": "Misleading",
        "explanation": "FDA identifies Semax free base and Semax acetate as distinct active ingredients. PubChem identifies N-acetyl Semax amidate as a chemically modified substance. A shared name does not establish the same structure, quality, safety, or evidence.",
        "category": "Product equivalence",
        "evidenceBasis": "Regulatory or product record",
        "scope": "Chemical-form and product-identity comparisons; this is not a use or administration recommendation.",
        "sourceUrls": [
          "https://www.fda.gov/media/193348/download",
          "https://precision.fda.gov/ginas/app/ui/substances/I5FAL2585H",
          "https://pubchem.ncbi.nlm.nih.gov/compound/N-acetyl-semax-amidate"
        ]
      }
    ],
    "sources": [
      {
        "label": "FDA evaluation of Semax-related bulk drug substances",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/media/193348/download",
        "kind": "FDA review",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
        "kind": "Regulatory",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Bulk drug substances used in compounding under section 503A",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
        "kind": "Regulatory",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "21 CFR 216.23 bulk drug substances list",
        "publisher": "Electronic Code of Federal Regulations",
        "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
        "kind": "Regulatory",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "FDA substance record for Semax free base",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://precision.fda.gov/ginas/app/ui/substances/I5FAL2585H",
        "kind": "Reference",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "The efficacy of Semax in the treatment of patients at different stages of ischemic stroke",
        "publisher": "PubMed",
        "url": "https://pubmed.ncbi.nlm.nih.gov/29798983/",
        "kind": "Human clinical study",
        "year": 2018,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Effectiveness of Semax in acute period of hemispheric ischemic stroke",
        "publisher": "PubMed",
        "url": "https://pubmed.ncbi.nlm.nih.gov/11517472/",
        "kind": "Human clinical study",
        "year": 1997,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Resting brain-scan study in 24 healthy adults",
        "publisher": "PubMed · Frontiers in Human Neuroscience",
        "url": "https://pubmed.ncbi.nlm.nih.gov/30225715/",
        "kind": "Human pharmacology",
        "year": 2018,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "N-acetyl Semax amidate identity record",
        "publisher": "PubChem",
        "url": "https://pubchem.ncbi.nlm.nih.gov/compound/N-acetyl-semax-amidate",
        "kind": "Reference",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "FDA advisory committee backs two more peptides, rejects one for compounding list",
        "publisher": "Regulatory Affairs Professionals Society",
        "url": "https://www.raps.org/resource/fda-advisory-committee-backs-two-more-peptides-rejects-one-for-compounding-list.html",
        "kind": "Reference",
        "year": 2026,
        "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"
    }
  }
}