{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:kerendia",
  "owner": "cardio",
  "kind": "product",
  "slug": "kerendia",
  "name": "Finerenone (Kerendia)",
  "aliases": [
    "Kerendia"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A prescription pill that contains finerenone, a non-steroidal medicine that blocks the mineralocorticoid receptor. In a large trial finerenone lowered the risk of kidney disease getting worse in people with chronic kidney disease and type 2 diabetes. This record does not list approved uses because no Kerendia label record was found.",
  "summary_technical": "FDA application NDA215341, applicant listed as BAYER HLTHCARE. Original approval on 2021-07-09 (ORIG-1, Type 1 - New Molecular Entity). Dosage form TABLET. openFDA returned no label record for the brand, so no indication text was read.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": null,
  "next_review_due": null,
  "identifiers": [],
  "navigation": {
    "cardio": {
      "system": [
        "kidneys"
      ],
      "condition-area": [
        "kidney-connections",
        "diabetes-and-metabolic-disease"
      ]
    }
  },
  "payload": {
    "subtype": "medicine",
    "model_or_formulation": "Tablet (dosage form TABLET on the openFDA record); several strengths.",
    "version": "Not stated in the sources read. The application covers several strengths and presentations.",
    "intended_use_snapshots": []
  },
  "content_digest": "2de4eaa04293f86fbca6135f95a3e7e905416d83b202656428b7a0c4744c1545",
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    "current": [],
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      "id": "cardio:claim-fda-nda215341-approval",
      "owner": "cardio",
      "subject_entity_id": "cardio:kerendia",
      "category": "regulatory",
      "statement": "The US Food and Drug Administration approved Kerendia (finerenone tablets) on 9 July 2021 under new drug application NDA215341. The Drugs@FDA page lists the original submission as ORIG-1, an approval, classified Type 1 - New Molecular Entity. The openFDA record lists the applicant as BAYER HLTHCARE.",
      "context": {
        "id": "cardio:ctx-fda-us-nda-approval-record",
        "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,
        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "Not applicable (regulatory decision)",
        "eligibility": {
          "inclusion": [],
          "exclusion": []
        }
      },
      "evidence_stage": "not_applicable",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "An FDA approval is a decision about a medicine, not a finding about how much it helps any person. The date comes from the Drugs@FDA page, which writes it as a month-first slash date. The openFDA record gives the date only as a compact number, so the page is quoted. No label record for Kerendia was returned by openFDA, so this atlas states no indication. openFDA says not to rely on it for decisions about medical care.",
      "editorial_state": "draft",
      "checked_at": "2026-10-14",
      "next_review_due": null,
      "valid_from": null,
      "valid_to": null,
      "citations": [
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            "source_effective_date": "2026-10-13",
            "public_archive_url": null,
            "source_state": "current"
          },
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            "publisher": "U.S. Food and Drug Administration (openFDA)",
            "edition": "The openFDA drugsfda record for application NDA215341 returned on 2026-10-14, from a dataset last updated 2026-10-13. It lists the applicant, products and submissions but gives the original approval date only as a compact number (YYYYMMDD), so the Drugs@FDA page is also kept as a snapshot.",
            "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted, as the openFDA terms page states (fetched 2026-10-14 as ch-openfda-terms.html, sha256 b11f712bfb11, hash only). The raw record is committed at research/snapshots/ch-openfda-nda215341.json.",
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        },
        {
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          "locator": "Original Approvals or Tentative Approvals, Action Date (MM/DD/YYYY)",
          "applicability_note": "Original approval date.",
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          },
          "source": {
            "id": "cardio:fda-daf-nda215341",
            "source_type": "regulator",
            "title": "Drugs@FDA: approval date(s) and history for NDA 215341 (Kerendia)",
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            "publisher": "U.S. Food and Drug Administration (Drugs@FDA)",
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            "public_text": "cite_only"
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        },
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            "title": "FDA New Drug Application NDA215341: Kerendia (openFDA drugsfda record)",
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            "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted, as the openFDA terms page states (fetched 2026-10-14 as ch-openfda-terms.html, sha256 b11f712bfb11, hash only). The raw record is committed at research/snapshots/ch-openfda-nda215341.json.",
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  ],
  "decisions": [
    {
      "type": "regulatory_decision",
      "id": "cardio:regdec-fda-nda215341",
      "product_id": "cardio:kerendia",
      "product_version": "Kerendia (finerenone) tablets, application NDA215341, original submission ORIG-1",
      "indication": "Not stated in the sources read. openFDA returned no label record for Kerendia.",
      "context_id": "cardio:ctx-fda-us-nda-approval-record",
      "jurisdictions": [
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      ],
      "jurisdiction_note": "United States",
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      "submission_id": "NDA215341",
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      "decision_date": "2021-07-09",
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  ],
  "milestones": [],
  "relationships": {
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        "predicate": "contains",
        "label": "Active ingredient on the openFDA application record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:finerenone",
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}