# Tirzepatide (Mounjaro) Product · id `cardio:mounjaro` · 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: Mounjaro Browse, organ or system: Metabolism Browse, condition area: Diabetes and metabolic disease ## In plain language 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. ## Technical summary 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. ## 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 Mounjaro (tirzepatide injection) on 13 May 2022 under new drug application NDA215866. 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 ELI LILLY AND CO. The Eli Lilly label record fetched on 2026-10-14 says Mounjaro is a GIP receptor and GLP-1 receptor agonist indicated to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes, and to reduce the risk of major cardiovascular events in adults with type 2 diabetes who are at high risk for these events. The recommended starting dosage is injected subcutaneously once weekly. - 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. The indications quoted are those on the label record fetched on 2026-10-14 and may differ from the original 2022 approval, which later supplements changed; the original indication is not in the sources read. openFDA says not to rely on it for decisions about medical care. The sources read do not show when the cardiovascular indication was added. - Last checked: 2026-10-14 - Sources: 1. Supports: FDA New Drug Application NDA215866: Mounjaro (openFDA drugsfda record) (Regulator, edition The openFDA drugsfda record for application NDA215866 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 2026-10-14T18:24:53Z. Source state: Current. Snapshot hash: 79a49c5b0a9b79d8dda1df406e431c61c3d9156064048d8c73e2cb7535a51cc5. How it applies: Application number and applicant. 2. Supports: Drugs@FDA: approval date(s) and history for NDA 215866 (Mounjaro) (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: 14938f9e72952a01ea7b876af5256ccf3bc6f269dfb1fee5f8c17a9c42186a39. How it applies: Original approval date. 3. Supports: FDA New Drug Application NDA215866: Mounjaro (openFDA drugsfda record) (Regulator, edition The openFDA drugsfda record for application NDA215866 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\[2\].submission\_type; results\[0\].submissions\[2\].submission\_status; results\[0\].submissions\[2\].submission\_class\_code\_description. Retrieved 2026-10-14T18:24:53Z. Source state: Current. Snapshot hash: 79a49c5b0a9b79d8dda1df406e431c61c3d9156064048d8c73e2cb7535a51cc5. How it applies: Original submission, its status and classification. 4. Supports: Mounjaro drug label (openFDA record, set id d2d7da5d-ad07-4228-955f-cf7e355c8cc0) (Label, edition openFDA drug label record, label effective 20260827, dataset last updated 2026-10-13.) Locator: results\[0\].indications\_and\_usage\[0\]; results\[0\].dosage\_and\_administration\[0\]. Retrieved 2026-10-14T18:28:16Z. Source state: Current. Snapshot hash: 31fcb7dc23292d577d0e9bb754e5d337b6b2bef062370c103570c397e018340e. How it applies: Indications and dosing on the label record. 5. Background: FDA New Drug Application NDA215866: Mounjaro (openFDA drugsfda record) (Regulator, edition The openFDA drugsfda record for application NDA215866 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 2026-10-14T18:24:53Z. Source state: Current. Snapshot hash: 79a49c5b0a9b79d8dda1df406e431c61c3d9156064048d8c73e2cb7535a51cc5. How it applies: Active ingredient on the application record. 6. Background: Mounjaro drug label (openFDA record, set id d2d7da5d-ad07-4228-955f-cf7e355c8cc0) (Label, edition openFDA drug label record, label effective 20260827, dataset last updated 2026-10-13.) Locator: results\[0\].openfda.manufacturer\_name\[0\]. Retrieved 2026-10-14T18:28:16Z. Source state: Current. Snapshot hash: 31fcb7dc23292d577d0e9bb754e5d337b6b2bef062370c103570c397e018340e. How it applies: The label record is from the manufacturer. 7. Background: Drugs@FDA: approval date(s) and history for NDA 215866 (Mounjaro) (Regulator, edition Drugs@FDA application overview page fetched 2026-10-14.) Locator: Supplements, Submission Classification. Retrieved 2026-10-14T18:24:54Z. Source state: Current. Snapshot hash: 14938f9e72952a01ea7b876af5256ccf3bc6f269dfb1fee5f8c17a9c42186a39. How it applies: The Drugs@FDA page lists later supplements classified as new indications, so the current label may differ from the original approval. ## Guidance, authorization and access ### Regulatory decision `cardio:regdec-fda-nda215866` - Product: Tirzepatide (Mounjaro) (`cardio:mounjaro`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Approval, 2022-05-13 - Product version: Mounjaro (tirzepatide) injection, application NDA215866, original submission ORIG-1 - Pathway: NDA - Submission: NDA215866 - Indication: The indication on the original approval was not read. The uses on the current label record are in claim-fda-nda215866-approval. - 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-nda215866-approval` ## Connected pages - Active ingredient on the openFDA application record: Tirzepatide (`cardio:tirzepatide`) - The openFDA record names Eli Lilly and Company as a manufacturer; the application sponsor is ELI LILLY AND CO: Eli Lilly and Company (`cardio:eli-lilly`) - Filed under this front: Medicines (`cardio:front-medicines`) - Investigated in: SURPASS-CVOT: tirzepatide against dulaglutide on major cardiovascular events (`cardio:surpass-cvot`) ## Provenance Content hash: 07e2001c1bfb1fb9063f2f7278435a80ce04f9072e7b3ab87a1686bd3767f94e Last substantive edit: 2026-10-14 Evidence last checked: Not recorded