# Finerenone (Kerendia) Product · id `cardio:kerendia` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: Kerendia Browse, organ or system: Kidneys Browse, condition area: Diabetes and metabolic disease; Kidney connections ## In plain language 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. ## Technical summary 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. ## Claims, with the population each applies to ## Context: United States FDA original approval of a new drug application (NDA) Recipient: Recipient not specified; 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: Not stated in the FDA records; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision) ### 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. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Recipient not specified; 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: Not stated in the FDA records; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision) - 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. - Last checked: 2026-10-14 - Sources: 1. Supports: FDA New Drug Application NDA215341: Kerendia (openFDA drugsfda record) (Regulator, 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.) Locator: results\[0\].application\_number; results\[0\].sponsor\_name. Retrieved 2026-10-14T18:24:54Z. Source state: Current. Snapshot hash: 3ad75e163b866653015aee0b31d67725c3aaf788abe55d149f53d65ab1f3385e. How it applies: Application number and applicant. 2. Supports: Drugs@FDA: approval date(s) and history for NDA 215341 (Kerendia) (Regulator, edition Drugs@FDA application overview page fetched 2026-10-14.) Locator: Original Approvals or Tentative Approvals, Action Date (MM/DD/YYYY). Retrieved 2026-10-14T18:24:54Z. Source state: Current. Snapshot hash: 1dbf2f78139897b5d65087d562dd452e07f39893a5c534b4c76ec8b0b669d490. How it applies: Original approval date. 3. Supports: FDA New Drug Application NDA215341: Kerendia (openFDA drugsfda record) (Regulator, 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.) Locator: results\[0\].submissions\[3\].submission\_type; results\[0\].submissions\[3\].submission\_status; results\[0\].submissions\[3\].submission\_class\_code\_description. Retrieved 2026-10-14T18:24:54Z. Source state: Current. Snapshot hash: 3ad75e163b866653015aee0b31d67725c3aaf788abe55d149f53d65ab1f3385e. How it applies: Original submission, its status and classification. 4. Background: FDA New Drug Application NDA215341: Kerendia (openFDA drugsfda record) (Regulator, 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.) Locator: results\[0\].products\[0\].active\_ingredients\[0\].name. Retrieved 2026-10-14T18:24:54Z. Source state: Current. Snapshot hash: 3ad75e163b866653015aee0b31d67725c3aaf788abe55d149f53d65ab1f3385e. How it applies: Active ingredient on the application record. ## Guidance, authorization and access ### Regulatory decision `cardio:regdec-fda-nda215341` - Product: Finerenone (Kerendia) (`cardio:kerendia`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Approval, 2021-07-09 - Product version: Kerendia (finerenone) tablets, application NDA215341, original submission ORIG-1 - Pathway: NDA - Submission: NDA215341 - Indication: Not stated in the sources read. openFDA returned no label record for Kerendia. - Jurisdictions: United States; note: United States - Applies to: Recipient: Recipient not specified; 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: Not stated in the FDA records; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision) - Basis: claim `cardio:claim-fda-nda215341-approval` ## Connected pages - Active ingredient on the openFDA application record: Finerenone (`cardio:finerenone`) - Applicant (listed as BAYER HLTHCARE) on the openFDA application record; the record does not say how that name relates to Bayer AG: Bayer (`cardio:bayer`) - Filed under this front: Kidney and metabolic care (`cardio:front-kidney-and-metabolic-care`) ## Provenance Content hash: 2de4eaa04293f86fbca6135f95a3e7e905416d83b202656428b7a0c4744c1545 Last substantive edit: 2026-10-15 Evidence last checked: Not recorded