{
  "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/abaloparatide",
  "canonicalUrl": "https://thepeptidefield.com/peptides/abaloparatide",
  "record": {
    "slug": "abaloparatide",
    "name": "Abaloparatide",
    "aliases": [
      "Tymlos",
      "BA058",
      "PTHrP analogue"
    ],
    "className": "Parathyroid hormone-related peptide analogue",
    "family": "Bone and tissue peptide medicines",
    "sequenceLabel": "34 amino acids · PTHrP analogue",
    "tier": "Established",
    "evidenceContext": "Approved human outcomes",
    "statusLine": "An FDA-approved product exists for defined osteoporosis populations",
    "productContext": "The study result belongs to the named prescription product, not every similar product or use. Tymlos is a product-specific prescription medicine. Trial findings do not validate unapproved PTHrP analogues or general performance use.",
    "approvedProducts": [
      "Tymlos"
    ],
    "productRecords": [
      {
        "name": "Tymlos",
        "formulation": "Injection pen",
        "route": "Subcutaneous",
        "indicationScope": "Osteoporosis uses in the high-fracture-risk populations defined in the product label.",
        "labelUrl": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208743Orig1s017lbl.pdf",
        "labelRevision": "2025 label"
      }
    ],
    "indications": [
      "Osteoporosis treatment or bone-density increase in labeled high-risk populations"
    ],
    "profile": {
      "humanOutcomes": {
        "level": "Strong",
        "note": "The ACTIVE phase 3 trial supports fracture-risk reduction in postmenopausal women with osteoporosis."
      },
      "humanPharmacology": {
        "level": "Strong",
        "note": "Approved labeling characterizes PTH1-receptor activity, exposure, and bone-turnover effects."
      },
      "safetyKnowledge": {
        "level": "Strong",
        "note": "Known risks and monitoring are described in the current product label."
      },
      "productCertainty": {
        "level": "Strong",
        "note": "High for authentic Tymlos used within the approved label."
      }
    },
    "oneLine": "An approved osteoporosis medicine with fracture evidence in defined groups and product-specific safety limits.",
    "reviewedAt": "July 23, 2026",
    "reviewedAtISO": "2026-07-23",
    "reviewHistory": [
      {
        "date": "2026-07-23",
        "note": "Initial brief based on the 2025 Tymlos label and ACTIVE phase 3 trial."
      }
    ],
    "whatItIs": "Abaloparatide is a man-made version of a parathyroid hormone-related peptide. It acts at the PTH1 receptor and is used as a medicine to help build bone.",
    "whatWeKnow": "The ACTIVE study compared abaloparatide with placebo or open-label teriparatide in postmenopausal women with osteoporosis. Abaloparatide reduced new spine and non-spine fractures versus placebo over 18 months.",
    "whatWeDoNotKnow": "The result does not establish that it is better than every osteoporosis medicine, improves healthy people, or heals every new injury better.",
    "antiDoping": null,
    "safetyBoundary": "This prescription osteoporosis medicine has product-specific warnings and limits on use. No dose, injection, or performance guidance is provided.",
    "relatedSlugs": [
      "teriparatide"
    ],
    "claims": [
      {
        "claim": "“Abaloparatide reduced fractures in a randomized phase 3 trial.”",
        "verdict": "Supported with scope",
        "explanation": "ACTIVE found fewer new vertebral and nonvertebral fractures versus placebo in postmenopausal women with osteoporosis.",
        "category": "Clinical outcomes",
        "evidenceBasis": "Randomized human outcomes",
        "scope": "Postmenopausal women with osteoporosis at fracture risk over 18 months.",
        "sourceUrls": [
          "https://pubmed.ncbi.nlm.nih.gov/27533157/"
        ]
      },
      {
        "claim": "“Abaloparatide is proven to improve bone outcomes in every population.”",
        "verdict": "Not established",
        "explanation": "Approved indications and trial populations define the evidence boundary.",
        "category": "Clinical outcomes",
        "evidenceBasis": "Randomized human outcomes",
        "scope": "Populations outside the current label and pivotal trial.",
        "sourceUrls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208743Orig1s017lbl.pdf"
        ]
      },
      {
        "claim": "“An anabolic bone effect means abaloparatide is a safe performance enhancer.”",
        "verdict": "Misleading",
        "explanation": "A prescription osteoporosis benefit-risk assessment does not establish safe enhancement in healthy people.",
        "category": "Performance and recovery",
        "evidenceBasis": "Regulatory or product record",
        "scope": "Healthy or athletic performance use.",
        "sourceUrls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208743Orig1s017lbl.pdf"
        ]
      }
    ],
    "sources": [
      {
        "label": "TYMLOS (abaloparatide) prescribing information",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208743Orig1s017lbl.pdf",
        "kind": "Drug label",
        "year": 2025,
        "accessedAt": "2026-07-23"
      },
      {
        "label": "Abaloparatide vs placebo on new vertebral fractures: ACTIVE",
        "publisher": "PubMed · JAMA",
        "url": "https://pubmed.ncbi.nlm.nih.gov/27533157/",
        "kind": "Randomized trial",
        "year": 2016,
        "accessedAt": "2026-07-23"
      },
      {
        "label": "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": "2026-07-23"
      }
    ],
    "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": "2026-07-23"
    }
  }
}