{
  "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/cerebrolysin",
  "canonicalUrl": "https://thepeptidefield.com/peptides/cerebrolysin",
  "record": {
    "slug": "cerebrolysin",
    "name": "Cerebrolysin",
    "aliases": [
      "Cerebrolysin Ebewe",
      "Cerebrolyzin",
      "FPE 1070",
      "FPE 1070 (IS)",
      "FPF 1070 (IS)",
      "Renacenz"
    ],
    "className": "Pig-brain-derived peptide mixture",
    "family": "Neuroactive peptide mixtures",
    "sequenceLabel": "Peptide mixture · no single amino-acid sequence",
    "tier": "Emerging",
    "evidenceContext": "Investigational human outcomes",
    "statusLine": "Authorized in Austria; no FDA-approved Cerebrolysin product was identified in the United States as reviewed August 30, 2026",
    "productContext": "Cerebrolysin is a specific finished product made from a pig-brain-derived peptide mixture. An FDA substance record and an Austrian authorization do not make every brain hydrolysate, compounded product, or online product equivalent to Cerebrolysin.",
    "approvedProducts": [],
    "productRecords": [],
    "indications": [
      "Human research after acute stroke",
      "Human research in vascular dementia and Alzheimer's disease"
    ],
    "profile": {
      "humanOutcomes": {
        "level": "Moderate",
        "note": "Randomized human studies include a large stroke trial and smaller dementia trials. The largest stroke trial found no significant difference on its main recovery measure."
      },
      "humanPharmacology": {
        "level": "Limited",
        "note": "Cerebrolysin is a mixture, not one defined molecule. Its product information says researchers cannot directly track the whole mixture through the body."
      },
      "safetyKnowledge": {
        "level": "Limited",
        "note": "The stroke evidence found a possible increase in serious health problems that did not cause death. Product information also lists important warnings and adverse effects."
      },
      "productCertainty": {
        "level": "Limited",
        "note": "High for the named Austrian finished product; low for generic brain hydrolysates, compounded products, or products sold online."
      }
    },
    "oneLine": "An Austrian-authorized finished product made from a pig-brain peptide mixture, not one peptide. Human trials exist, but no FDA-approved U.S. product was identified.",
    "reviewedAt": "August 30, 2026",
    "reviewedAtISO": "2026-08-30",
    "reviewHistory": [
      {
        "date": "2026-08-30",
        "note": "Initial brief reviewed FDA identity and orphan-designation records, Austrian product information, randomized human trials, composition studies, and the 2026 World Anti-Doping Agency list."
      }
    ],
    "whatItIs": "Cerebrolysin is not one peptide. It is a finished product made from a mixture of short peptides produced by breaking down pig-brain proteins in a controlled process. FDA's substance record lists pig brain protein as the source. It calls Cerebrolysin structurally diverse, which means it is a mixture rather than one molecule. The Austrian BASG product information describes an authorized finished product. Because it is a mixture, it has no single amino-acid sequence.",
    "whatWeKnow": "CASTA was the largest randomized stroke trial. It enrolled 1,070 adults with a stroke caused by a blocked blood vessel. Its main recovery measure found no clear difference between Cerebrolysin and placebo. A 2023 Cochrane review covered seven studies and 1,773 people. It included one study of Cortexin, a similar product. The review found no clear drop in deaths. It found a possible rise in serious health problems that did not cause death.",
    "whatWeDoNotKnow": "A 2019 Cochrane review covered six vascular-dementia studies with 597 people. Study problems made the evidence very uncertain. Any benefit might be too small to matter. One Alzheimer's study included 192 people, but it did not settle the wider question. FDA has an identity record and an orphan drug designation for Cerebrolysin. Neither means product approval. No FDA-approved U.S. product was found. Online and related brain-peptide products are not proven equal to Cerebrolysin.",
    "antiDoping": "The reviewed 2026 World Anti-Doping Agency list does not name Cerebrolysin. The Austrian authorization means it is not automatically in WADA's S0 group for substances with no government approval.",
    "antiDopingReview": {
      "status": "No prohibition identified",
      "detail": "Cerebrolysin is not named in the reviewed 2026 WADA Prohibited List. The product is authorized in Austria, so it is not automatically in WADA's S0 group for substances with no government approval. This is not personal clearance. Athletes must check the current list and the rules that apply to their sport.",
      "sourceUrl": "https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf",
      "reviewedAtISO": "2026-08-30"
    },
    "safetyBoundary": "The available evidence does not define the full safety profile of every Cerebrolysin product or related mixture. The 2023 stroke review found a possible increase in serious health problems that did not cause death. This guide does not diagnose, treat, recommend, or provide product-use or sourcing instructions.",
    "relatedSlugs": [
      "thymosin-alpha-1",
      "bpc-157",
      "mots-c"
    ],
    "claims": [
      {
        "claim": "“Cerebrolysin has been studied in randomized human trials.”",
        "verdict": "Supported with scope",
        "explanation": "Yes. CASTA and other randomized studies tested the named product in defined groups and settings. The existence of these studies does not prove a benefit for every outcome or product.",
        "category": "Clinical outcomes",
        "evidenceBasis": "Randomized human outcomes",
        "scope": "The exact Cerebrolysin product, study group, comparison, outcome, and follow-up period in each randomized trial.",
        "sourceUrls": [
          "https://pubmed.ncbi.nlm.nih.gov/22282884/",
          "https://pubmed.ncbi.nlm.nih.gov/37818733/",
          "https://pubmed.ncbi.nlm.nih.gov/31710397/"
        ]
      },
      {
        "claim": "“The largest randomized stroke trial proved that Cerebrolysin improves recovery.”",
        "verdict": "Misleading",
        "explanation": "CASTA enrolled 1,070 adults, but its main combined recovery measure showed no significant difference between Cerebrolysin and placebo. A subgroup finding was not the main planned result and does not prove a general recovery benefit.",
        "category": "Clinical outcomes",
        "evidenceBasis": "Randomized human outcomes",
        "scope": "CASTA: adults with acute ischemic stroke studied for up to 90 days. The result applies to its planned primary measure and study population.",
        "sourceUrls": [
          "https://pubmed.ncbi.nlm.nih.gov/22282884/"
        ]
      },
      {
        "claim": "“Cerebrolysin is FDA-approved in the United States.”",
        "verdict": "Misleading",
        "explanation": "No FDA-approved U.S. Cerebrolysin product was identified in the reviewed approval database. An FDA substance record or orphan designation does not mean that FDA approved a product.",
        "category": "Approval and status",
        "evidenceBasis": "Regulatory or product record",
        "scope": "United States regulatory status as reviewed August 30, 2026. Austrian authorization is a separate country status.",
        "sourceUrls": [
          "https://precision.fda.gov/ginas/app/ui/substances/8880c9ea-4705-45eb-b514-40316e135bdd",
          "https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products",
          "https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases"
        ]
      },
      {
        "claim": "“Every pig-brain peptide product is equivalent to Cerebrolysin.”",
        "verdict": "Misleading",
        "explanation": "Cerebrolysin is a specific finished product and mixture. One 2015 sample contained 638 unique peptides. A 2024 study found different contents and activity in related products. A shared pig-brain source does not prove the same identity, contents, quality, or human evidence.",
        "category": "Product equivalence",
        "evidenceBasis": "Regulatory or product record",
        "scope": "The named Austrian product and the exact product, process, composition, and quality record of any other preparation.",
        "sourceUrls": [
          "https://medikamente.basg.gv.at/documents/1-21380__DOTC_FACH_INFO.pdf",
          "https://pubmed.ncbi.nlm.nih.gov/26017115/",
          "https://pubmed.ncbi.nlm.nih.gov/38737662/"
        ]
      }
    ],
    "sources": [
      {
        "label": "FDA Global Substance Registration System record for Cerebrolysin",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://precision.fda.gov/ginas/app/ui/substances/8880c9ea-4705-45eb-b514-40316e135bdd",
        "kind": "Reference",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "FDA orphan drug designation explainer",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products",
        "kind": "Regulatory",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "FDA drug approvals and databases",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases",
        "kind": "Regulatory",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Cerebrolysin Austrian product information",
        "publisher": "Austrian Federal Office for Safety in Health Care (BASG)",
        "url": "https://medikamente.basg.gv.at/documents/1-21380__DOTC_FACH_INFO.pdf",
        "kind": "Drug label",
        "year": 2021,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "CASTA randomized acute stroke trial",
        "publisher": "PubMed · Stroke",
        "url": "https://pubmed.ncbi.nlm.nih.gov/22282884/",
        "kind": "Randomized trial",
        "year": 2012,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "CASTA trial record (NCT00868283)",
        "publisher": "ClinicalTrials.gov",
        "url": "https://clinicaltrials.gov/study/NCT00868283",
        "kind": "Trial registry",
        "year": 2009,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Cochrane review of Cerebrolysin for acute ischemic stroke",
        "publisher": "PubMed · Cochrane Database of Systematic Reviews",
        "url": "https://pubmed.ncbi.nlm.nih.gov/37818733/",
        "kind": "Science review",
        "year": 2023,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Cochrane review of Cerebrolysin for vascular dementia",
        "publisher": "PubMed · Cochrane Database of Systematic Reviews",
        "url": "https://pubmed.ncbi.nlm.nih.gov/31710397/",
        "kind": "Science review",
        "year": 2019,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Randomized Cerebrolysin study in Alzheimer's disease",
        "publisher": "PubMed · Journal of Neural Transmission",
        "url": "https://pubmed.ncbi.nlm.nih.gov/12111446/",
        "kind": "Randomized trial",
        "year": 2002,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Peptide profile of an Internet-obtained Cerebrolysin sample",
        "publisher": "PubMed · Drug Testing and Analysis",
        "url": "https://pubmed.ncbi.nlm.nih.gov/26017115/",
        "kind": "Reference",
        "year": 2015,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Comparison of Cerebrolysin with other peptide preparations",
        "publisher": "PubMed · Journal of Medical Life",
        "url": "https://pubmed.ncbi.nlm.nih.gov/38737662/",
        "kind": "Reference",
        "year": 2024,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "2026 Prohibited List",
        "publisher": "World Anti-Doping Agency",
        "url": "https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf",
        "kind": "Anti-doping",
        "year": 2026,
        "accessedAt": "2026-08-30"
      }
    ]
  }
}