{
  "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/bremelanotide",
  "canonicalUrl": "https://thepeptidefield.com/peptides/bremelanotide",
  "record": {
    "slug": "bremelanotide",
    "name": "Bremelanotide",
    "aliases": [
      "PT-141",
      "Vyleesi",
      "bremelanotide acetate"
    ],
    "className": "Melanocortin receptor agonist",
    "family": "Melanocortin medicines",
    "sequenceLabel": "7 amino acids · cyclic peptide",
    "tier": "Established",
    "evidenceContext": "Approved human outcomes",
    "statusLine": "An FDA-approved product exists for a narrow indication",
    "productContext": "Evidence for Vyleesi does not automatically apply to every PT-141 product. Vyleesi is an approved, product-specific presentation. Calling any PT-141 product 'Vyleesi' or transferring its evidence to compounded material is not justified.",
    "approvedProducts": [
      "Vyleesi"
    ],
    "productRecords": [
      {
        "name": "Vyleesi",
        "formulation": "Single-dose autoinjector",
        "route": "Subcutaneous",
        "indicationScope": "Acquired, generalized hypoactive sexual desire disorder in the premenopausal population and circumstances defined in the label.",
        "labelUrl": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf",
        "labelRevision": "September 2020"
      }
    ],
    "indications": [
      "Acquired, generalized hypoactive sexual desire disorder in certain premenopausal women"
    ],
    "profile": {
      "humanOutcomes": {
        "level": "Moderate",
        "note": "Two phase 3 trials support modest changes in prespecified desire and distress endpoints for the labeled population."
      },
      "humanPharmacology": {
        "level": "Strong",
        "note": "Exposure and transient cardiovascular effects are characterized in the approved label."
      },
      "safetyKnowledge": {
        "level": "Strong",
        "note": "The label describes blood-pressure effects, contraindications, nausea, pigmentation, and other risks."
      },
      "productCertainty": {
        "level": "Strong",
        "note": "High for authentic Vyleesi; evidence does not automatically transfer to compounded PT-141."
      }
    },
    "oneLine": "An approved medicine for one defined sexual-desire disorder. It is not a general sexual-performance enhancer.",
    "reviewedAt": "August 1, 2026",
    "reviewedAtISO": "2026-08-01",
    "reviewHistory": [
      {
        "date": "2026-08-01",
        "note": "Revalidated the Vyleesi indication and limitations against FDA labeling, including that approval is limited to acquired, generalized HSDD in specified premenopausal women and is not for sexual-performance enhancement."
      },
      {
        "date": "2026-07-23",
        "note": "Initial brief based on the Vyleesi label, RECONNECT trials, and FDA multidisciplinary review."
      }
    ],
    "whatItIs": "Bremelanotide is the active ingredient in Vyleesi and acts on melanocortin receptors. The approved use has diagnosis, population, and exclusion criteria.",
    "whatWeKnow": "The RECONNECT phase 3 trials reported improvements in planned measures of desire and distress in premenopausal women with acquired, generalized HSDD. HSDD is a diagnosed form of low sexual desire. The label says it is not indicated to enhance sexual performance.",
    "whatWeDoNotKnow": "The evidence does not establish treatment of all causes of low desire, benefit in men or postmenopausal women, a relationship benefit for everyone, or equivalence of compounded PT-141.",
    "antiDoping": null,
    "safetyBoundary": "The label says the product must not be used with uncontrolled hypertension or known cardiovascular disease. It also describes temporary blood-pressure increases. This guide provides no dosing or injection advice.",
    "relatedSlugs": [
      "afamelanotide"
    ],
    "claims": [
      {
        "claim": "“Bremelanotide is FDA-approved for a specific form of HSDD.”",
        "verdict": "Supported with scope",
        "explanation": "Vyleesi is approved for acquired, generalized HSDD in certain premenopausal women after specified exclusions.",
        "category": "Approval and status",
        "evidenceBasis": "Regulatory or product record",
        "scope": "The population and limitations in the current Vyleesi label.",
        "sourceUrls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf"
        ]
      },
      {
        "claim": "“PT-141 is an approved sexual-performance enhancer for anyone.”",
        "verdict": "Misleading",
        "explanation": "The label explicitly says the product is not for enhancing sexual performance and is not indicated for men or postmenopausal women.",
        "category": "Clinical outcomes",
        "evidenceBasis": "Regulatory or product record",
        "scope": "Vyleesi's labeled indication and limitations.",
        "sourceUrls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf"
        ]
      },
      {
        "claim": "“Compounded PT-141 has the same evidence as Vyleesi.”",
        "verdict": "Not established",
        "explanation": "The trial and approval record are product-specific and do not establish equivalence for compounded material.",
        "category": "Product equivalence",
        "evidenceBasis": "Regulatory or product record",
        "scope": "Compounded or research-labeled bremelanotide products.",
        "sourceUrls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000MultidisciplineR.pdf"
        ]
      }
    ],
    "sources": [
      {
        "label": "VYLEESI (bremelanotide) prescribing information",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf",
        "kind": "Drug label",
        "year": 2020,
        "accessedAt": "2026-07-23"
      },
      {
        "label": "Bremelanotide for HSDD: two randomized phase 3 trials",
        "publisher": "PubMed · Obstetrics & Gynecology",
        "url": "https://pubmed.ncbi.nlm.nih.gov/31599840/",
        "kind": "Randomized trial",
        "year": 2019,
        "accessedAt": "2026-07-23"
      },
      {
        "label": "Vyleesi multidisciplinary review",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000MultidisciplineR.pdf",
        "kind": "FDA review",
        "year": 2019,
        "accessedAt": "2026-07-23"
      }
    ],
    "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": "2026-08-01"
    }
  }
}