Tirzepatide (Mounjaro)

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)

• Regulatory Evidence stage not applicable Certainty not assessed

  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.

  Applies to Recipient not specified

  • 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.
  • Not stated in the FDA records
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA records
  • Gestational age Not reported
  • Postnatal age Not reported

  Follow-up Not applicable (regulatory decision)

  Certainty method

  Not assessed

  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

  Next evidence check due

  Not scheduled

  Sources and citations (7)

  1. Supports FDA New Drug Application NDA215866: Mounjaro (openFDA drugsfda record)

     Regulator · U.S. Food and Drug Administration (openFDA) · 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. · NDA: NDA215866

     Locator

     results[0].application_number; results[0].sponsor_name

     How it applies

     Application number and applicant.

     Retrieved

     2026-10-14T18:24:53Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     79a49c5b0a9b79d8dda1df406e431c61c3d9156064048d8c73e2cb7535a51cc5

     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-nda215866.json.

  2. Supports Drugs@FDA: approval date(s) and history for NDA 215866 (Mounjaro)

     Regulator · U.S. Food and Drug Administration (Drugs@FDA) · Edition Drugs@FDA application overview page fetched 2026-10-14.

     Locator

     Original Approvals or Tentative Approvals, Action Date (MM/DD/YYYY)

     How it applies

     Original approval date.

     Retrieved

     2026-10-14T18:24:54Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     14938f9e72952a01ea7b876af5256ccf3bc6f269dfb1fee5f8c17a9c42186a39

     Reuse basis

     The FDA website policies page (fetched 2026-10-14 as ch-fda-website-policies.html, sha256 59b7c8541753, hash only) says that, unless otherwise noted, the contents of the FDA website (www.fda.gov) are not copyrighted and are in the public domain. This page is on the accessdata.fda.gov host of FDA; the policy page names www.fda.gov only, so the terms for this host are unverified and the source is cite_only: facts are stated in the atlas's own words, with no quoted span. The raw page is committed at research/snapshots/ch-fda-daf-nda215866.html.

  3. Supports FDA New Drug Application NDA215866: Mounjaro (openFDA drugsfda record)

     Regulator · U.S. Food and Drug Administration (openFDA) · 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. · NDA: NDA215866

     Locator

     results[0].submissions[2].submission_type; results[0].submissions[2].submission_status; results[0].submissions[2].submission_class_code_description

     How it applies

     Original submission, its status and classification.

     Retrieved

     2026-10-14T18:24:53Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     79a49c5b0a9b79d8dda1df406e431c61c3d9156064048d8c73e2cb7535a51cc5

     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-nda215866.json.

  4. Supports Mounjaro drug label (openFDA record, set id d2d7da5d-ad07-4228-955f-cf7e355c8cc0)

     Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260827, dataset last updated 2026-10-13. · SPL set id: d2d7da5d-ad07-4228-955f-cf7e355c8cc0

     Locator

     results[0].indications_and_usage[0]; results[0].dosage_and_administration[0]

     How it applies

     Indications and dosing on the label record.

     Retrieved

     2026-10-14T18:28:16Z

     Source effective date

     2026-08-27

     Source state

     Current

     Snapshot hash

     31fcb7dc23292d577d0e9bb754e5d337b6b2bef062370c103570c397e018340e

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/ch-openfda-label-d2d7da5d-ad07-4228-955f-cf7e355c8cc0.json.

  5. Background FDA New Drug Application NDA215866: Mounjaro (openFDA drugsfda record)

     Regulator · U.S. Food and Drug Administration (openFDA) · 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. · NDA: NDA215866

     Locator

     results[0].products[0].active_ingredients[0].name

     How it applies

     Active ingredient on the application record.

     Retrieved

     2026-10-14T18:24:53Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     79a49c5b0a9b79d8dda1df406e431c61c3d9156064048d8c73e2cb7535a51cc5

     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-nda215866.json.

  6. Background Mounjaro drug label (openFDA record, set id d2d7da5d-ad07-4228-955f-cf7e355c8cc0)

     Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260827, dataset last updated 2026-10-13. · SPL set id: d2d7da5d-ad07-4228-955f-cf7e355c8cc0

     Locator

     results[0].openfda.manufacturer_name[0]

     How it applies

     The label record is from the manufacturer.

     Retrieved

     2026-10-14T18:28:16Z

     Source effective date

     2026-08-27

     Source state

     Current

     Snapshot hash

     31fcb7dc23292d577d0e9bb754e5d337b6b2bef062370c103570c397e018340e

     Reuse basis

     openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/ch-openfda-label-d2d7da5d-ad07-4228-955f-cf7e355c8cc0.json.

  7. Background Drugs@FDA: approval date(s) and history for NDA 215866 (Mounjaro)

     Regulator · U.S. Food and Drug Administration (Drugs@FDA) · Edition Drugs@FDA application overview page fetched 2026-10-14.

     Locator

     Supplements, Submission Classification

     How it applies

     The Drugs@FDA page lists later supplements classified as new indications, so the current label may differ from the original approval.

     Retrieved

     2026-10-14T18:24:54Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     14938f9e72952a01ea7b876af5256ccf3bc6f269dfb1fee5f8c17a9c42186a39

     Reuse basis

     The FDA website policies page (fetched 2026-10-14 as ch-fda-website-policies.html, sha256 59b7c8541753, hash only) says that, unless otherwise noted, the contents of the FDA website (www.fda.gov) are not copyrighted and are in the public domain. This page is on the accessdata.fda.gov host of FDA; the policy page names www.fda.gov only, so the terms for this host are unverified and the source is cite_only: facts are stated in the atlas's own words, with no quoted span. The raw page is committed at research/snapshots/ch-fda-daf-nda215866.html.