{
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  "id": "cardio:mounjaro",
  "owner": "cardio",
  "kind": "product",
  "slug": "mounjaro",
  "name": "Tirzepatide (Mounjaro)",
  "aliases": [
    "Mounjaro"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A prescription tirzepatide injection given once a week, for adults and children aged 10 and over with type 2 diabetes. It acts on two receptors, called GIP and GLP-1. The FDA label record also lists lowering the risk of major heart and blood-vessel events in adults with type 2 diabetes at high risk of them. The SURPASS-CVOT trial compared tirzepatide with dulaglutide.",
  "summary_technical": "FDA application NDA215866, applicant listed as ELI LILLY AND CO. Original approval on 2022-05-13 (ORIG-1, Type 1 - New Molecular Entity). Dosage form SOLUTION. The Eli Lilly label record used for the indications has an effective date of 2026-08-27. The openFDA record names Eli Lilly and Company as a manufacturer, and this record links to the Eli Lilly organization record.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
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  "navigation": {
    "cardio": {
      "system": [
        "metabolism"
      ],
      "condition-area": [
        "diabetes-and-metabolic-disease"
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    }
  },
  "payload": {
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    "model_or_formulation": "Solution for subcutaneous injection (dosage form SOLUTION on the openFDA record); several strengths.",
    "version": "Not stated in the sources read. The application covers several strengths and presentations.",
    "intended_use_snapshots": [
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        "label": "United States FDA original approval of a new drug application (NDA)",
        "recipient": "unknown",
        "population": "Not stated in the FDA application records read. The records give the applicant, the products and the submission history; the label record gives age limits for each indication.",
        "care_setting": "Not stated in the FDA records",
        "geography": "United States (decision by the US Food and Drug Administration)",
        "life_stage_note": "Not stated in the FDA records",
        "life_stage_terms": null,
        "gestational_age_min_days": null,
        "gestational_age_max_days": null,
        "gestational_age_basis": null,
        "postnatal_age_min_days": null,
        "postnatal_age_max_days": null,
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        "postnatal_age_status": null,
        "followup_description": "Not applicable (regulatory decision)",
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      "certainty": "not_assessed",
      "certainty_method": null,
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