{
  "data": {
    "id": "bremelanotide",
    "canonicalName": "Bremelanotide",
    "aliases": [
      "PT-141"
    ],
    "exactForm": "pending",
    "route": "pending",
    "dosageForm": "pending",
    "intendedUse": "human use (unspecified)",
    "productStatus": "FDA-approved: VYLEESI (AUTOINJECTOR) (NDA210557)",
    "compoundingStatus": "Not verified",
    "evidenceTier": "FDA-approved product exists",
    "answer": "Bremelanotide has FDA-approved prescription products (VYLEESI (AUTOINJECTOR) (NDA210557)). Bremelanotide is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 10 registered ClinicalTrials.gov studies cite Bremelanotide (9 completed, 1 active not recruiting); registration is not evidence of approval, efficacy, or safety. CompoundedGuide is verifying compounding status, safety signals, and current evidence. This is not medical advice.",
    "uncertainty": [
      "FDA approval status read from a captured openFDA Drugs@FDA response covering 1 application number.",
      "Approval data is not editorially reviewed; it reports what the FDA record says.",
      "Trial counts are read from a captured ClinicalTrials.gov response citing 10 specific study records, not from an open search.",
      "503B Bulks List membership was read from the list page captured 2026-07-25; being off that list is not itself a statement that compounding is lawful or unlawful.",
      "Compounding status, shortage status, and safety profile are not yet verified.",
      "This is not a medical, legal, or professional endorsement."
    ],
    "lane": "approved",
    "commercialPolicy": "none",
    "reviewedAt": "2026-07-25",
    "sources": [
      {
        "id": "fda_openfda_drugsfda",
        "title": "openFDA Drugs@FDA",
        "authorityTier": "P0",
        "url": "https://api.fda.gov/drug/drugsfda.json?search=application_number%3A(%22NDA210557%22)&limit=50",
        "retrievedAt": "2026-07-25T13:21:02.250Z"
      },
      {
        "id": "fda_503b_bulks",
        "title": "503B Bulks List and Interim Categories",
        "authorityTier": "P0",
        "url": "https://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list",
        "retrievedAt": "2026-07-25T04:39:30.052Z"
      },
      {
        "id": "clinicaltrials_gov_api",
        "title": "ClinicalTrials.gov API v2",
        "authorityTier": "P0",
        "url": "https://clinicaltrials.gov/api/v2/studies?filter.ids=NCT00425256,NCT01382719,NCT02333071,NCT02338960,NCT03973047,NCT04179734,NCT04943068,NCT05709444,NCT06565611,NCT06867835&pageSize=50&countTotal=true",
        "retrievedAt": "2026-07-25T01:36:38.190Z"
      }
    ],
    "trials": [
      {
        "nctId": "NCT06867835",
        "title": "Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06565611",
        "title": "A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT05709444",
        "title": "A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2022"
      },
      {
        "nctId": "NCT04943068",
        "title": "A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2021"
      },
      {
        "nctId": "NCT03973047",
        "title": "Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2019"
      },
      {
        "nctId": "NCT04179734",
        "title": "Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2019"
      },
      {
        "nctId": "NCT02338960",
        "title": "2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2015"
      },
      {
        "nctId": "NCT02333071",
        "title": "1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2014"
      },
      {
        "nctId": "NCT01382719",
        "title": "Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2011"
      },
      {
        "nctId": "NCT00425256",
        "title": "Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2006"
      }
    ],
    "pendingResources": {
      "identity": [
        "FDA/NCATS GSRS or equivalent canonical identity source"
      ],
      "product_status": [
        "Drugs@FDA, Purple Book, Orange Book, DailyMed, or applicable primary FDA record"
      ],
      "compounding_status": [
        "FDA 503A/503B pages, Federal Register, docket, or applicable final/interim policy"
      ],
      "safety": [
        "FDA safety communication, warning, recall, FAERS signal context, or explicit absence statement"
      ],
      "evidence": [
        "ClinicalTrials.gov and PubMed/primary publication search"
      ],
      "state_or_facility": [
        "State board or FDA facility record when relevant"
      ]
    }
  }
}