U.S. label recordMetabolic

Tirzepatide

Related names in cited records: Zepbound, Mounjaro

A GIP and GLP-1 receptor agonist. This profile cites a Zepbound label and an FDA notice.

Citation markers ↗ open the public records supporting the adjacent statements.

Correction · September 15, 2026

We refreshed this profile's label citation to the reviewed SPL version 40, published 2026-09-02. Earlier profile versions retain their original label citations. The product-specific label account identifies its reviewed scope. 1

This version supersedes public version 3.

Start here

The evidence at a glance

What is its status in the cited records?

U.S. label record. The cited DailyMed label identifies Tirzepatide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.

Status sources checked through September 15, 2026. See status sources and coverage →

What do the reviewed human studies say?

Human evidence reviewed August 19, 2026 · Review version 1.

Review source snapshots checked August 19, 2026 · Integrity checked August 19, 2026.

Publisher notices are registered for this reviewed source set. Inspect the notices and their scope →

A bounded review of two sponsor-funded randomized Phase 3 trials: one in adults with obesity without diabetes and one in adults with type 2 diabetes treated with diet and exercise alone.

What the reviewed sources report

The reviewed obesity trial reported greater weight reduction with tirzepatide than placebo, and the reviewed type 2 diabetes trial reported lower glycated hemoglobin and body weight than placebo. These trials do not answer every population, long-term outcome, or post-discontinuation question.

What remains unresolved?

  • What are the durability, post-discontinuation outcomes, and uncommon harms across broader populations and longer follow-up?

Read study designs, results, limitations, and sources →

What does the U.S. product label say?

Zepbound · Read September 15, 2026 · Preserved label summary 1

Which population and use does the label cover?

The cited Zepbound label covers long-term weight reduction in adults with obesity, or overweight with a weight-related condition, and moderate to severe obstructive sleep apnea in adults with obesity. Both indications are described alongside diet and physical activity. This is a product-specific account, separate from Mounjaro labeling. Label: 1 ↗

Which safety limits matter?

The boxed warning reports thyroid C-cell tumors in rats, with uncertain human relevance. Contraindications include a personal or family history of medullary thyroid carcinoma, MEN 2 and serious hypersensitivity. Warnings address severe gastrointestinal reactions, kidney injury from volume depletion, gallbladder disease, pancreatitis, hypoglycemia, diabetic retinopathy complications and aspiration during anesthesia or deep sedation. Label: boxed warning, 4, 5 ↗

Label edition and source pins

U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.

ZEPBOUND (tirzepatide) injection · SPL version 40 · published 2026-09-02

Label ZIP SHA-256: 4fe25d4173ba662adc2b4ac0653c09643bc7a9e883557286abe2c5d36f19d87e. Extracted XML SHA-256: 7c40611952c42e85d4688669dae2a5529cd563e0e857fdb23e411a8f7d8b0f14.

Open versioned label context data →

Reviews summarize selected studies; their scope and limitations are shown above.

Official-source update

Reviewed 2026-09-16 · Preserved version 1

FDA revisited the psychiatric-safety warning

On January 13, 2026, FDA requested removal of the suicidal-behavior and ideation warning from Zepbound labeling after its review found no increased risk. This records the agency’s request, not a claim that every label version has changed. FDA PDF pp. 1 ↗

More findings and the sources behind them

Selected FDA safety communications, read alongside the separately preserved product-label account and human evidence review.

What supported that finding

FDA combined 91 placebo-controlled trials involving 107,910 participants and examined a separate Sentinel claims cohort. These are class-wide analyses, not a dedicated trial of this peptide or a finding about every possible adverse effect. FDA PDF pp. 2, 3 ↗

Reports about compounded products need context

FDA reports adverse events associated with compounded tirzepatide, while noting underreporting and uncertain causality. Raw report totals do not establish an incidence rate or a fair comparison with approved products. FDA source ↗

What remains to be checked

  • Reconcile each current product and formulation label with subsequent safety and indication changes.
  • Appraise remaining eligible trial reports and follow-up studies; this update does not complete the literature review.
Source dates and review coverage

PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.

  • FDA January 2026 GLP-1 psychiatric-safety communication ↗

    Source dated 2026-01-13; retrieved 2026-09-16.

    • What Is FDA Doing? · PDF pp. 1 of 3
    • What Did FDA Find? · PDF pp. 2, 3 of 3

    SHA-256: d2cc0d43605a9300646146c86f0fd4b84611ada2272de7e65425f33fb7aae53c

  • FDA concerns with unapproved GLP-1 drugs ↗

    Source dated 2026-09-01; retrieved 2026-09-16.

    • Concerns with compounded versions of these drugs
    • Salt forms should not be used to compound semaglutide
    • Adverse events related to compounded versions of semaglutide and tirzepatide
    • Retatrutide and cagrilintide cannot be used in compounding

    SHA-256: bfb6cd2a11e3f8e20bedfeed0e0d554205c76dd83f473956deb82afc186e51cc

Open versioned findings and source records →

Inside the official reviews

Reviewed 2026-09-19 · Preserved version 1

The five trials had different comparisons

EMA’s July 2022 assessment covers SURPASS-1 through SURPASS-5 in type 2 diabetes. Placebo comparisons were blinded, while several active-comparator trials were open-label and used different background therapies. EMA PDF pp. 203 ↗

More findings, study links and document coverage

An effect estimate depends on what happened after discontinuation

The review distinguishes an analysis including treatment changes and nonadherence from an efficacy analysis assuming intended treatment without rescue. These address different questions and should not be merged into one headline estimate. EMA PDF pp. 204 ↗

Comparisons apply to the regimens actually studied

The assessment found greater glycemic and weight improvements than its studied comparators, including the then-studied semaglutide regimen. This does not establish superiority over every formulation, regimen, population or later trial. EMA PDF pp. 203, 204 ↗

Important populations were sparsely represented

EMA noted limited clinical evidence in severe kidney or liver impairment, alongside gastrointestinal adverse effects and treatment discontinuations. This original diabetes assessment is distinct from later weight-management and other indication reviews. EMA PDF pp. 205, 211 ↗

Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.

Document coverage

Selected sections read in 1 of 1 inventoried documents; 0 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.

One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading. EMA inventory source ↗

Inspect documents, application identities and source pins

Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.

  • Mounjaro : EPAR - Public assessment report ↗

    Selected sections reviewed · ema-56782 · Document/feed date: 2022-11-25

    Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.

    Verified: Mounjaro · EMEA/H/C/005620 · Document dated 2022-07-21. Identity checked on PDF pp. 1.

    Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.

    Retrieved 2026-09-19. Read PDF pages: 1, 203, 204, 205, 211 of 212. SHA-256: dec7c5c0d0692f96f66dff032922f375b9aecb73948c663c4df4bb5d80e10283.

    Feed-listed application (not a verified association): EMEA/H/C/005620.

Remaining work

  • Review later weight-management, sleep-apnea and cardiovascular-outcomes assessments separately from SURPASS.
  • Appraise trial publications and statistical plans with their treatment-policy and efficacy estimands preserved.

Open versioned document coverage and study pins →

European medicine records · 1 products or applications

EMA medicine metadata checked 2026-09-15. These are product-specific centralized records; national European authorizations and full product-information assessments require separate coverage.

Application withdrawal and refusal are distinct from marketing authorization. A withdrawal status alone does not establish why it occurred. These metadata entries do not substitute for indication, population or safety details in the relevant product information.

Open versioned records and source-feed pins →

Research coverage and study families

Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.

Open machine-readable coverage and record decisions →

PubMed search

Catalog-name and calibrated alias discovery for human evidence review. Complete query retrieval is separate from clinical eligibility, study-family linkage and appraisal.

2536 retrieved · 2 included · 0 excluded · 2534 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Tirzepatide"[Title/Abstract] OR "LY3298176"[Title/Abstract] OR "Zepbound"[Title/Abstract] OR "Mounjaro"[Title/Abstract]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:09:34.746094+00:00 · HTTP 200 · SHA-256 6718b12adfb2e4a719e68b213b4dd9711b817f95e9e6607b8ab15438c278e7a3.

  • Retrieved IDs completely represent this query response, not all relevant literature. Additional aliases, references and non-PubMed sources require separate searches.
  • Unscreened records may include animal or cell experiments, reviews, secondary analyses, mixtures, protocols and unrelated name matches.
  • Study-family mappings use available declared registry IDs; unresolved mappings do not create independent trial counts. Full-text, corrections and registry comparison remain separate work.
  • Linked correction notices require comparison with the selected reports: PMID34274062 for PMID34186022. Their presence does not establish what changed.

Showing 25 of 2536 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 35658024 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT04184622.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 f9a0b5da75a39caf7fb0ec78c5ca8b51a7e6169ea325c39a631aea907b2ccc37.

  2. PubMed 34186022 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT03954834.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 6ead3603e27422b9a993fbe4aeada5d423750fea734bfa8e01b00164201535c6.

    • PubMed links an erratum: Department of Error. ↗. Impact on the selected study summary remains unresolved.

      Notice XML SHA-256 77b4137f3d2d133936904bcae84dd9ceb73746fc92a75dcbfd9962b1a50ac157.

  3. PubMed 42738922 — not screened: Name-query match awaiting clinical eligibility screening.
  4. PubMed 42736522 — not screened: Name-query match awaiting clinical eligibility screening.
  5. PubMed 42736027 — not screened: Name-query match awaiting clinical eligibility screening.
  6. PubMed 42735883 — not screened: Name-query match awaiting clinical eligibility screening.
  7. PubMed 42735880 — not screened: Name-query match awaiting clinical eligibility screening.
  8. PubMed 42735799 — not screened: Name-query match awaiting clinical eligibility screening.
  9. PubMed 42734711 — not screened: Name-query match awaiting clinical eligibility screening.
  10. PubMed 42733229 — not screened: Name-query match awaiting clinical eligibility screening.
  11. PubMed 42733128 — not screened: Name-query match awaiting clinical eligibility screening.
  12. PubMed 42732962 — not screened: Name-query match awaiting clinical eligibility screening.
  13. PubMed 42732434 — not screened: Name-query match awaiting clinical eligibility screening.
  14. PubMed 42730869 — not screened: Name-query match awaiting clinical eligibility screening.
  15. PubMed 42730175 — not screened: Name-query match awaiting clinical eligibility screening.
  16. PubMed 42730051 — not screened: Name-query match awaiting clinical eligibility screening.
  17. PubMed 42729958 — not screened: Name-query match awaiting clinical eligibility screening.
  18. PubMed 42729808 — not screened: Name-query match awaiting clinical eligibility screening.
  19. PubMed 42729636 — not screened: Name-query match awaiting clinical eligibility screening.
  20. PubMed 42728528 — not screened: Name-query match awaiting clinical eligibility screening.
  21. PubMed 42727867 — not screened: Name-query match awaiting clinical eligibility screening.
  22. PubMed 42727208 — not screened: Name-query match awaiting clinical eligibility screening.
  23. PubMed 42723821 — not screened: Name-query match awaiting clinical eligibility screening.
  24. PubMed 42722006 — not screened: Name-query match awaiting clinical eligibility screening.
  25. PubMed 42721915 — not screened: Name-query match awaiting clinical eligibility screening.

FDA search

Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.

2 retrieved · 2 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

products.active_ingredients.name:"TIRZEPATIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:31.074889+00:00 · HTTP 200 · SHA-256 0d4220dedbf91bfc45402994a814b980dfa5e3cc9eb52c9cda14c9b63e6435d1.

  • Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
  • This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.

Showing 2 of 2 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. FDA NDA217806 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: TIRZEPATIDE.
  2. FDA NDA215866 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: TIRZEPATIDE.

EMA search

Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.

1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Tirzepatide", "Zepbound", "Mounjaro"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:22.905972+00:00 · HTTP 200 · SHA-256 a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA EMEA/H/C/005620 — include: EMA feed product Mounjaro; reported status: Authorised. Exact indication and decision documents remain unappraised.

EMA search

Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.

27 retrieved · 14 included · 0 excluded · 13 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Tirzepatide", "Zepbound", "Mounjaro"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:29.167460+00:00 · HTTP 200 · SHA-256 c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 25 of 27 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA 56782 — include: Document linked by EMA product number; content unappraised. Mounjaro : EPAR - Public assessment report
  2. EMA 62228 — include: Document linked by EMA product number; content unappraised. Mounjaro-H-C-PSUSA-00011019-202211 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  3. EMA 62456 — include: Document linked by EMA product number; content unappraised. Mounjaro-H-C-005620-II-0007 : EPAR - Assessment report - Variation
  4. EMA 56780 — include: Document linked by EMA product number; content unappraised. Mounjaro : EPAR - All authorised presentations
  5. EMA 65380 — include: Document linked by EMA product number; content unappraised. Mounjaro-H-C-PSUSA-00011019-202311 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  6. EMA 66627 — include: Document linked by EMA product number; content unappraised. Mounjaro-H-C-005620-II-0027 : EPAR - Assessment report - Variation
  7. EMA 67371 — include: Document linked by EMA product number; content unappraised. Mounjaro-H-C-PSUSA-00011019-202405 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  8. EMA 57804 — include: Document linked by EMA product number; content unappraised. Mounjaro : EPAR - Procedural steps taken and scientific information after authorisation (archive)
  9. EMA 56778 — include: Document linked by EMA product number; content unappraised. Mounjaro : EPAR - Medicine Overview
  10. EMA 75020 — include: Document linked by EMA product number; content unappraised. Mounjaro-H-C-005620-II-0038 : EPAR - Assessment report - Variation
  11. EMA 75019 — include: Document linked by EMA product number; content unappraised. Mounjaro-VR-0000281937 : EPAR - Assessment report - Variation
  12. EMA 56779 — include: Document linked by EMA product number; content unappraised. Mounjaro : EPAR - Product Information
  13. EMA 71029 — include: Document linked by EMA product number; content unappraised. Mounjaro : EPAR - Product information - tracked changes
  14. EMA 67859 — include: Document linked by EMA product number; content unappraised. Mounjaro : EPAR - Procedural steps taken and scientific information after authorisation
  15. EMA 55640 — not screened: Title-name match awaiting identity and document review. CHMP summary of positive opinion for Mounjaro
  16. EMA 60836 — not screened: Title-name match awaiting identity and document review. CHMP post-authorisation summary of positive opinion for Mounjaro (II-07)
  17. EMA 66099 — not screened: Title-name match awaiting identity and document review. Questions and answers on the outcome of assessment on use of Mounjaro in treatment of obstructive sleep apnoea
  18. EMA 64106 — not screened: Title-name match awaiting identity and document review. P/0285/2023 : EMA decision of 24 July 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (Mounjaro), (EMEA-002360-PIP02-22-M01)
  19. EMA 62016 — not screened: Title-name match awaiting identity and document review. P/0033/2023 : EMA decision of 31 January 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tirzepatide (Mounjaro) (EMEA-002360-PIP02-22)
  20. EMA 58712 — not screened: Title-name match awaiting identity and document review. P/0174/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (EMEA- 002360-PIP01-18-M02)
  21. EMA 58171 — not screened: Title-name match awaiting identity and document review. P/0540/2021 : EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (EMEA-002360-PIP01-18-M01)
  22. EMA 47070 — not screened: Title-name match awaiting identity and document review. P/0311/2019: EMA decision of 10 September 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tirzepatide (EMEA-002360-PIP01-18)
  23. EMA 66804 — not screened: Title-name match awaiting identity and document review. P/0478/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (Mounjaro), (EMEA-002360-PIP02-22-M02)
  24. EMA 71723 — not screened: Title-name match awaiting identity and document review. CHMP post-authorisation summary of positive opinion for Mounjaro (EMAVR0000281937)
  25. EMA 72384 — not screened: Title-name match awaiting identity and document review. Questions and answers on the outcome of assessment on use of Mounjaro in treatment of heart failure with preserved ejection fraction in adults with obesity

EMA search

Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.

0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Tirzepatide", "Zepbound", "Mounjaro"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:31.262344+00:00 · HTTP 200 · SHA-256 7448bf4e77e3345b3f3fbb7062c335d2302d8ea458a246bbe8256ce48aad2806.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

    ClinicalTrials.gov search

    ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.

    303 retrieved · 0 included · 0 excluded · 303 awaiting a decision · 0 full-text appraisals

    Search terms, record decisions and remaining work

    "Tirzepatide" OR "Zepbound" OR "Mounjaro"

    Source retrievals and payload pins
    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:27:13.534758+00:00 · HTTP 200 · SHA-256 650a3281586b667a7cdab447366465bab12c9ea6d8b08810f6c1eea31e095e1d.

    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:27:14.744600+00:00 · HTTP 200 · SHA-256 52e7bbfc128f5e113db4a23049e10df69b79875befab03dfd481a565f3f5c87a.

    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:27:16.028869+00:00 · HTTP 200 · SHA-256 ae959c58735fb59feba020a72b39c6fd4dadbb2abe3232bbf2d230c8621c1ea4.

    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:27:16.863384+00:00 · HTTP 200 · SHA-256 0c6b3bb52f9ac6d11208d55aa2138cd1ff79af74174dd52cd29f7e875e0ea8e5.

    • Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
    • Other registries, unregistered studies and additional aliases remain outside this query.

    Showing 25 of 303 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

    1. ClinicalTrials.gov NCT06606821 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    2. ClinicalTrials.gov NCT07697391 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    3. ClinicalTrials.gov NCT06994338 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    4. ClinicalTrials.gov NCT07194317 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    5. ClinicalTrials.gov NCT07382180 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    6. ClinicalTrials.gov NCT07555730 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    7. ClinicalTrials.gov NCT07720466 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    8. ClinicalTrials.gov NCT06914154 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    9. ClinicalTrials.gov NCT05812183 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    10. ClinicalTrials.gov NCT06467604 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    11. ClinicalTrials.gov NCT07299084 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    12. ClinicalTrials.gov NCT07423247 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    13. ClinicalTrials.gov NCT06584916 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    14. ClinicalTrials.gov NCT07756359 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    15. ClinicalTrials.gov NCT06732245 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    16. ClinicalTrials.gov NCT06790225 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    17. ClinicalTrials.gov NCT06515418 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    18. ClinicalTrials.gov NCT04050670 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    19. ClinicalTrials.gov NCT06373146 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    20. ClinicalTrials.gov NCT06779929 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    21. ClinicalTrials.gov NCT05708859 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    22. ClinicalTrials.gov NCT04004988 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    23. ClinicalTrials.gov NCT03311724 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    24. ClinicalTrials.gov NCT05990374 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    25. ClinicalTrials.gov NCT05564039 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    Read the full Human Evidence Review

    Supervised synthesis

    What do selected human studies report about Tirzepatide?

    Manually reviewed August 19, 2026 · version 1

    Browse all Human Evidence Reviews · Open preserved synthesis version 1 →

    A bounded review of two sponsor-funded randomized Phase 3 trials: one in adults with obesity without diabetes and one in adults with type 2 diabetes treated with diet and exercise alone.12

    Bottom line from this bounded source set

    The reviewed obesity trial reported greater weight reduction with tirzepatide than placebo, and the reviewed type 2 diabetes trial reported lower glycated hemoglobin and body weight than placebo. These trials do not answer every population, long-term outcome, or post-discontinuation question.12

    Reviewed study record

    SURMOUNT-1 obesity trial

    Design

    A double-blind, randomized, placebo-controlled Phase 3 trial assessed body-weight change over 72 weeks.1

    Population

    The trial randomized 2,539 adults with obesity, or overweight plus at least one weight-related complication, and excluded people with diabetes.1

    Outcomes reported

    Reported mean body-weight change at week 72 ranged from -15.0% to -20.9% across tirzepatide groups and was -3.1% with placebo. Gastrointestinal events were the most common adverse events, and discontinuation for adverse events was more frequent in the tirzepatide groups.1

    Limitations

    The sponsor-funded trial used a dose-escalation period, excluded diabetes, and does not by itself establish outcomes after treatment stops or uncommon harms over longer periods.1

    Reviewed study record

    SURPASS-1 type 2 diabetes trial

    Design

    A double-blind, randomized, placebo-controlled Phase 3 trial assessed glycated hemoglobin, body weight, safety, and tolerability over 40 weeks.2

    Population

    The trial randomized 478 adults with type 2 diabetes inadequately controlled by diet and exercise who had not previously used injectable diabetes therapy.2

    Outcomes reported

    Reported mean glycated-hemoglobin change ranged from -1.87 to -2.07 percentage points across tirzepatide groups and was +0.04 with placebo. Reported body-weight reduction ranged from 7.0 to 9.5 kilograms, and gastrointestinal events were the most frequent adverse events.2

    Limitations

    The sponsor-funded trial was limited to 40 weeks and a treatment-naive type 2 diabetes population. Crossref also registers a publisher erratum for this publication; metadata alone does not describe the corrected wording.2

    Reviewed source set

    1. PubMed · 35658024Tirzepatide Once Weekly for the Treatment of Obesity ↗PubMed PMID 35658024 · EFetch XML reviewed 2026-08-19 · payload SHA-256 f9a0b5da75a39caf7fb0ec78c5ca8b51a7e6169ea325c39a631aea907b2ccc37
      No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1056/nejmoa2206038. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
    2. PubMed · 34186022Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial ↗PubMed PMID 34186022 · EFetch XML reviewed 2026-08-19 · payload SHA-256 6ead3603e27422b9a993fbe4aeada5d423750fea734bfa8e01b00164201535c6
      Publication update registered by CrossrefErratum ↗ · publisher metadata · July 17, 2021. Crossref metadata identifies the notice but does not by itself explain what wording changed.
    Explore status sources, recent additions, and coverage gaps

    Living status brief

    What is the current status of Tirzepatide?

    U.S. label record. The cited DailyMed label identifies Tirzepatide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.

    The cited status sources were checked through September 15, 2026. This answer changes only through the profile’s visible version and correction history.

    Evidence present

    What records are connected here?

    Evidence lanes
    4
    Source years
    5
    Drugs@FDA applications
    2

    These are counts in PeptideScanner’s selected public collection, not measures of research quality, medical relevance, safety, or effectiveness.

    Latest source-dated record

    What changed most recently at a cited source?

    Clinical trials · source date September 9, 2026

    ClinicalTrials.gov record NCT07247084Added to PeptideScanner September 9, 2026

    Coverage gaps

    What remains unknown or unsupported?

    All four evidence lanes appear in this selected collection, but their presence does not establish completeness, agreement, research quality, safety, effectiveness, approval, availability, or suitability.

    PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.

    Explore the Evidence Map and record counts

    Evidence Map v1

    What kinds of records connect to Tirzepatide?

    Compare collection coverage →

    This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.

    169Selected dated records
    172Connected citations
    5Populated source years2022–2026
    4/4Record lanes present

    Registered human studies

    Trial composition

    19 of 67 selected trial records include at least one phase value; 19 of 67 include a status value in the retained structured contract.

    514 public history versions connect to 65 of these trial records across 8 submitted years. Open the record-history collection →

    1 exact source-declared trial-publication link connects selected NCT and PMID records. Open the exact graph →

    PhasesPhase 2 11Phase 4 5Phase 1 2Phase 3 2Early Phase 1 1
    Status at observationRecruiting 10Not yet recruiting 5Completed 2Active, not recruiting 1Enrolling by invitation 1

    A phase value is unavailable here for 48 selected records; this is not counted as “no phase.”

    A status value is unavailable here for 48 selected records; this is not counted as a trial status.

    PubMed bibliography

    Publication composition

    24 of 66 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

    Publication typesJournal Article 15Letter 6Editorial 2Published Erratum 2Review 2Case Reports 1Clinical Trial, Phase III 1Comment 1Meta-Analysis 1Multicenter Study 1Observational Study 1Preprint 1Randomized Controlled Trial 1Systematic Review 1

    Bibliography fields unavailable here for 42 selected records; the records remain visible as metadata observations.

    Regulatory and publication surfaces

    What is structurally connected?

    Drugs@FDA applications
    2
    FDA Federal Register documents
    8
    DailyMed SPL versions
    22
    Canonical profile
    Published
    Profile structured data
    Published
    Linked dated records
    169

    Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.

    Profile publication history and record counts

    Exact identifier graph

    1 trial-publication link for Tirzepatide

    Open the full graph →

    These links come only from structured NCT and PMID identifiers declared by PubMed or ClinicalTrials.gov. They do not summarize the publications or establish findings.

    Research hub

    Explore the Tirzepatide evidence record

    Open all 169 records →
    169Dated records
    4Evidence types
    169Cited public sources
    5Source years

    Change ledger

    Recently changed for Tirzepatide

    Open all 172 events →

    PeptideScanner change dates and cited source dates stay separate. These entries report collection or version activity, not a ranking of importance.

    Correction

    Tirzepatide profile

    We refreshed this profile's label citation to the reviewed SPL version 40, published 2026-09-02. Earlier profile versions retain their original label citations. The product-specific label account identifies its reviewed scope.

    PeptideScanner change date
    September 15, 2026
    Evidence lane
    Profile
    Record added

    Tirzepatide DailyMed SPL version 40

    DailyMed lists Structured Product Labeling version 40 for the reviewed Tirzepatide label family with a published date of 2026-09-02. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

    PeptideScanner change date
    September 15, 2026
    Cited source date
    September 2, 2026
    Evidence lane
    Regulatory
    Record added

    ClinicalTrials.gov record NCT06439277

    PeptideScanner retained ClinicalTrials.gov record NCT06439277 at 2026-09-09T19:17:17.406Z. Its registry update date was 2026-09-04, and PeptideScanner's reviewed identity mapping was tirzepatide.

    PeptideScanner change date
    September 9, 2026
    Cited source date
    September 4, 2026
    Evidence lane
    Clinical trials

    Official-source collections

    Source records for Tirzepatide

    Open the full research atlas →
    PubMed66

    24 with attributed title, venue, publication-date, and type metadata.

    1. Are We Asking About Tirzepatide? Emerging Oral Health Implications for Oral Medicine Practice.Oral diseases · 2026 09 04
    2. Correction: Clinical Implications of Mounjaro (Tirzepatide) for Breast Cancer Detection and Management: A Narrative Review.Cureus · 2026 06 30
    3. Can the NHS afford Mounjaro? It spent £574m on the jab last year despite most eligible patients not getting it.BMJ (Clinical research ed.) · 2026 06 28
    Explore all selected literature →
    ClinicalTrials.gov67

    514 public history versions across these dated registry records; status labels apply only to each cited observation.

    1. NCT07247084Registry update September 9, 2026 · current at observation
    2. NCT06439277Registry update September 4, 2026 · current at observation
    3. NCT07046819Registry update August 12, 2026 · current at observation
    Explore all selected trial records →Explore all public record history →
    DailyMed SPL history22

    Version metadata and exact historical ZIP receipts for the reviewed label family, without reproducing or interpreting label text.

    1. SPL version 40Published 2026-09-02 · ZIP SHA-256 4fe25d4173ba…
    2. SPL version 38Published 2026-05-06 · ZIP SHA-256 8b4500aaf49b…
    3. SPL version 37Published 2026-03-03 · ZIP SHA-256 f967eee30fbf…
    4. SPL version 36Published 2026-02-26 · ZIP SHA-256 024c61f53130…
    5. SPL version 32Published 2026-02-05 · ZIP SHA-256 67650e830f92…
    Explore all DailyMed label versions →

    Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.

    Evidence types

    Coverage by source year

    Selected records span May 13, 2022 to September 9, 2026.

    Continue exploring

    Profiles with overlapping source-year coverage

    Open the research atlas →

    These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.

    Glucagon5 shared source years308 dated records · 4 evidence typesSemaglutide5 shared source years237 dated records · 4 evidence typesLeuprolide5 shared source years215 dated records · 4 evidence typesLiraglutide5 shared source years167 dated records · 4 evidence types

    These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.

    Evidence summary

    What the cited records say

    The cited DailyMed label identifies Tirzepatide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.

    This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.

    Cited context

    Related records

    Organizations named in cited records

    • U.S. National Library of Medicine

    Dated source history

    Updates connected to this profile

    Open the full cross-source timeline →
    1. Clinical trials

      ClinicalTrials.gov record NCT07247084

      PeptideScanner retained ClinicalTrials.gov record NCT07247084 at 2026-09-09T19:17:17.101Z. Its registry update date was 2026-09-09, and PeptideScanner's reviewed identity mapping was tirzepatide.

    2. Clinical trials

      ClinicalTrials.gov record NCT06439277

      PeptideScanner retained ClinicalTrials.gov record NCT06439277 at 2026-09-09T19:17:17.406Z. Its registry update date was 2026-09-04, and PeptideScanner's reviewed identity mapping was tirzepatide.

    3. Literature metadata

      Are We Asking About Tirzepatide? Emerging Oral Health Implications for Oral Medicine Practice.

      PubMed lists PMID 42695200 in Oral diseases as Letter, with publication-date metadata of 2026-09-04 (day precision). PeptideScanner associated the retained record with the identity slug tirzepatide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

    4. Regulatory

      Tirzepatide DailyMed SPL version 40

      DailyMed lists Structured Product Labeling version 40 for the reviewed Tirzepatide label family with a published date of 2026-09-02. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

    5. Literature metadata

      Inflammation-mediated facial nodules to compounded tirzepatide.

      PubMed lists PMID 42598502 in JAAD case reports as Letter, with publication-date metadata of 2026-06-17 (day precision). PeptideScanner associated the retained record with the identity slug tirzepatide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

    6. Literature metadata

      Tirzepatide and Autonomic Dysfunction: Insights From Postural Orthostatic Tachycardia Syndrome.

      PubMed lists PMID 41945548 in JACC. Case reports as Letter, with publication-date metadata of 2025-12-17 (day precision). PeptideScanner associated the retained record with the identity slug tirzepatide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

    7. Literature metadata

      Facial nodules following filler injections after initiating compounded tirzepatide use.

      PubMed lists PMID 42088720 in JAAD case reports as Case Reports, Journal Article, with publication-date metadata of 2026-03-27 (day precision). PeptideScanner associated the retained record with the identity slug tirzepatide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

    8. Clinical trials

      ClinicalTrials.gov record NCT07463846

      PeptideScanner retained ClinicalTrials.gov record NCT07463846 at 2026-08-13T05:54:14.856Z. Its registry update date was 2026-08-12, and PeptideScanner's reviewed identity mapping was tirzepatide.

    9. Clinical trials

      ClinicalTrials.gov record NCT07046819

      PeptideScanner retained ClinicalTrials.gov record NCT07046819 at 2026-08-13T05:54:14.859Z. Its registry update date was 2026-08-12, and PeptideScanner's reviewed identity mapping was tirzepatide.

    10. Clinical trials

      ClinicalTrials.gov record NCT07734870

      PeptideScanner retained ClinicalTrials.gov record NCT07734870 at 2026-08-13T05:54:14.859Z. Its registry update date was 2026-08-12, and PeptideScanner's reviewed identity mapping was tirzepatide.

    11. Clinical trials

      ClinicalTrials.gov record NCT06965413

      PeptideScanner retained ClinicalTrials.gov record NCT06965413 at 2026-08-13T05:52:27.007Z. Its registry update date was 2026-08-11, and PeptideScanner's reviewed identity mapping was tirzepatide.

    12. Clinical trials

      ClinicalTrials.gov record NCT06651177

      PeptideScanner retained ClinicalTrials.gov record NCT06651177 at 2026-08-13T05:52:27.017Z. Its registry update date was 2026-08-11, and PeptideScanner's reviewed identity mapping was tirzepatide.