PeptideScanner
U.S. label record↗Metabolic↗

Lixisenatide↗

Related names in cited records: Soliqua 100/33↗

A GLP-1 receptor agonist component. This profile cites a U.S. combination-product label.↗

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

Correction · September 15, 2026

We added a preserved FDA-hosted product label to support the product-specific label account. Prior profile versions retain their original citations. 2

This version supersedes public version 2.

Start here

The evidence at a glance

What is its status in the cited records?

U.S. label record. The cited DailyMed label identifies Lixisenatide 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 July 22, 2026. See status sources and coverage →

What do the reviewed human studies say?

Human evidence reviewed September 15, 2026 · Review version 1.

Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.

Two selected trials address cardiovascular outcomes in type 2 diabetes and exploratory motor outcomes in early Parkinson disease. These are lixisenatide trials, not evidence for the insulin-glargine combination as an interchangeable intervention.↗↗

What the reviewed sources report

ELIXA met cardiovascular noninferiority but did not demonstrate cardiovascular superiority. A smaller Parkinson trial reported less motor-score worsening over 12 months, with gastrointestinal adverse effects; it does not establish neuroprotection or a new approved indication.↗↗

What remains unresolved?

  • How do the monotherapy and fixed-combination regulatory records differ?↗↗
  • What do the broader diabetes program and subsequent Parkinson trials establish?↗↗

Read study designs, results, limitations, and sources →

What does the U.S. product label say?

ADLYXIN, revised November 2024 · Read September 15, 2026 · Preserved label summary 1

Which population and use does the label cover?

This single-ingredient label covers glycemic control alongside diet and exercise in adults with type 2 diabetes. It is separate from the insulin glargine/lixisenatide combination label cited by the profile, and does not establish current commercial availability. Label: 1 ↗

Which safety limits matter?

The label contraindicates severe hypersensitivity and addresses anaphylaxis, pancreatitis, hypoglycemia with insulin or insulin secretagogues, acute kidney injury, immunogenicity, gallbladder disease and aspiration during anesthesia or deep sedation. It does not recommend use in gastroparesis. Label: 4, 5, 6 ↗

Label edition and source pins

FDA-hosted U.S. prescribing information. This account concerns this product and label edition; other formulations and jurisdictions require their own records.

ADLYXIN, revised November 2024: U.S. prescribing information

Label PDF SHA-256: 62efbf5418ef53b5e665d679c1184fa7bc006960fb487a68aa04bf1e2a04d597.

Open versioned label context data →

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

European medicine records · 2 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

Identity/name search without publication-type filtering; primary human reports, extensions, combinations and other reports require separate eligibility decisions. Known selected reports were recovered.

731 retrieved · 2 included · 0 excluded · 729 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"lixisenatide"[Title/Abstract] OR "Adlyxin"[Title/Abstract] OR "Lyxumia"[Title/Abstract] OR "AVE0010"[Title/Abstract]

  • Full-text appraisal and screening of unassessed records remain open.
  • Registry comparison, additional aliases and references, and regulator reconciliation require separate checks.

Showing 25 of 731 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 38598572 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT03439943.
  2. PubMed 26630143 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT01147250.
  3. PubMed 42473266 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  4. PubMed 42697752 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  5. PubMed 42692277 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  6. PubMed 42687799 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  7. PubMed 42556625 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  8. PubMed 42401410 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  9. PubMed 42387313 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  10. PubMed 42698423 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  11. PubMed 42609010 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  12. PubMed 30000034 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  13. PubMed 42666495 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  14. PubMed 42584027 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  15. PubMed 42296503 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  16. PubMed 42259643 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  17. PubMed 42186210 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  18. PubMed 42025665 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  19. PubMed 41792979 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  20. PubMed 40145958 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  21. PubMed 42536323 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  22. PubMed 42490867 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  23. PubMed 41994910 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  24. PubMed 41444101 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  25. PubMed 42452511 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.

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:"LIXISENATIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:20.426246+00:00 · HTTP 200 · SHA-256 52975787c4c73c59eeda23a5adc9bd409cf0b7c1ecb610165e61aea10d76da2a.

  • 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 BLA208673 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: INSULIN GLARGINE, LIXISENATIDE.
  2. FDA BLA208471 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIXISENATIDE.

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.

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

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Lixisenatide", "Soliqua 100/33"]

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 2 of 2 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/004243 — include: EMA feed product Suliqua; reported status: Authorised. Exact indication and decision documents remain unappraised.
  2. EMA EMEA/H/C/002445 — include: EMA feed product Lyxumia; reported status: Withdrawn. 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.

25 retrieved · 16 included · 0 excluded · 9 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Lixisenatide", "Soliqua 100/33"]

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

  1. EMA 20482 — include: Document linked by EMA product number; content unappraised. Suliqua : EPAR - Public assessment report
  2. EMA 30245 — include: Document linked by EMA product number; content unappraised. Suliqua : EPAR - All Authorised presentations
  3. EMA 38350 — include: Document linked by EMA product number; content unappraised. Suliqua : EPAR - Medicine overview
  4. EMA 46983 — include: Document linked by EMA product number; content unappraised. Suliqua-H-C-PSUSA-00010577-201905 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  5. EMA 47100 — include: Document linked by EMA product number; content unappraised. Suliqua-H-C-4243-II-0011: EPAR - Assessment Report- Variation
  6. EMA 55983 — include: Document linked by EMA product number; content unappraised. Suliqua-H-C-PSUSA-00010577-202111 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  7. EMA 49818 — include: Document linked by EMA product number; content unappraised. Lyxumia : EPAR - Risk-management-plan summary
  8. EMA 28007 — include: Document linked by EMA product number; content unappraised. Lyxumia : EPAR - Public assessment report
  9. EMA 32330 — include: Document linked by EMA product number; content unappraised. Lyxumia : EPAR - All Authorised presentations
  10. EMA 39362 — include: Document linked by EMA product number; content unappraised. Lyxumia : EPAR - Procedural steps taken and scientific information after authorisation (archive)
  11. EMA 64723 — include: Document linked by EMA product number; content unappraised. Lyxumia : EPAR - Procedural steps taken and scientific information after authorisation
  12. EMA 13355 — include: Document linked by EMA product number; content unappraised. Lyxumia : EPAR - Summary for the public
  13. EMA 41911 — include: Document linked by EMA product number; content unappraised. Suliqua : EPAR - Procedural steps taken and scientific information after authorisation (archive)
  14. EMA 21962 — include: Document linked by EMA product number; content unappraised. Lyxumia : EPAR - Product Information
  15. EMA 21301 — include: Document linked by EMA product number; content unappraised. Suliqua : EPAR - Product Information
  16. EMA 74418 — include: Document linked by EMA product number; content unappraised. Suliqua : EPAR - Procedural steps taken and scientific information after authorisation
  17. EMA 52578 — not screened: Title-name match awaiting identity and document review. P/0443/2020 : EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide (Lyxumia) (EMEA-000916-PIP01-10-M07)
  18. EMA 28652 — not screened: Title-name match awaiting identity and document review. P/18/2011: EMA decision of 24 January 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lixisenatide (EMEA-000916-PIP01-10) in accordance with...
  19. EMA 43773 — not screened: Title-name match awaiting identity and document review. P/0380/2018: of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide (Lyxumia), (EMEA-000916-PIP01-10-M06)
  20. EMA 15493 — not screened: Title-name match awaiting identity and document review. P/0076/2012: EMA decision of 25 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide (EMEA- 000916-PIP01-10-M02)
  21. EMA 24408 — not screened: Title-name match awaiting identity and document review. P/0035/2013: EMA decision of 27 February 2013 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide, (EMEA-000916-PIP01-10-M03)
  22. EMA 26848 — not screened: Title-name match awaiting identity and document review. P/225/2011: EMA decision of 27 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide (EMEA- 000916-PIP01-10-M01)
  23. EMA 29319 — not screened: Title-name match awaiting identity and document review. P/168/2010: European Medicines Agency decision of 3 September 2010 on the granting of a product specific waiver for lixisenatide / insulin glargine, (EMEA-000915-PIP01-10)
  24. EMA 41211 — not screened: Title-name match awaiting identity and document review. P/0037/2015: EMA decision of 6 March 2015 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide (Lyxumia) (EMEA-000916-PIP01-10-M04)
  25. EMA 41987 — not screened: Title-name match awaiting identity and document review. P/0133/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide (Lyxumia), (EMEA-000916-PIP01-10-M05)

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: ["Lixisenatide", "Soliqua 100/33"]

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.

    77 retrieved · 0 included · 0 excluded · 77 awaiting a decision · 0 full-text appraisals

    Search terms, record decisions and remaining work

    "Lixisenatide" OR "Soliqua 100/33" OR "Suliqua" OR "Lyxumia"

    Source retrievals and payload pins
    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:26:37.727814+00:00 · HTTP 200 · SHA-256 bdda076efe1ebae2665d67b06921b3c4adcab9247da30f819e4c7697cae6e80d.

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

    1. ClinicalTrials.gov NCT01960179 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    2. ClinicalTrials.gov NCT02276196 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    3. ClinicalTrials.gov NCT02058160 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    4. ClinicalTrials.gov NCT03798054 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    5. ClinicalTrials.gov NCT03881995 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    6. ClinicalTrials.gov NCT00931372 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    7. ClinicalTrials.gov NCT00763451 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    8. ClinicalTrials.gov NCT04196231 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    9. ClinicalTrials.gov NCT07173712 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    10. ClinicalTrials.gov NCT03819790 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    11. ClinicalTrials.gov NCT02767596 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    12. ClinicalTrials.gov NCT02501850 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    13. ClinicalTrials.gov NCT01572649 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    14. ClinicalTrials.gov NCT02713477 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    15. ClinicalTrials.gov NCT01147250 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    16. ClinicalTrials.gov NCT07274644 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    17. ClinicalTrials.gov NCT00715624 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    18. ClinicalTrials.gov NCT01146678 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    19. ClinicalTrials.gov NCT00763815 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    20. ClinicalTrials.gov NCT02168491 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    21. ClinicalTrials.gov NCT03798080 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    22. ClinicalTrials.gov NCT06716424 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    23. ClinicalTrials.gov NCT05136287 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    24. ClinicalTrials.gov NCT00707031 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    25. ClinicalTrials.gov NCT00866658 — 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 Lixisenatide?

    Manually reviewed September 15, 2026 · version 1

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

    Two selected trials address cardiovascular outcomes in type 2 diabetes and exploratory motor outcomes in early Parkinson disease. These are lixisenatide trials, not evidence for the insulin-glargine combination as an interchangeable intervention.12

    Bottom line from this bounded source set

    ELIXA met cardiovascular noninferiority but did not demonstrate cardiovascular superiority. A smaller Parkinson trial reported less motor-score worsening over 12 months, with gastrointestinal adverse effects; it does not establish neuroprotection or a new approved indication.12

    Reviewed study record

    ELIXA: cardiovascular outcomes

    Design

    Randomized placebo-controlled trial added lixisenatide or placebo to usual care.1

    Population

    6,068 people with type 2 diabetes and a recent acute coronary event were followed for a median of 25 months.1

    Outcomes reported

    The primary cardiovascular composite occurred in 13.4% versus 13.2%; hazard ratio 1.02 (95% CI 0.89–1.17). Noninferiority was met, superiority was not. Serious adverse events were not more frequent with lixisenatide.1

    Limitations

    The result is a cardiovascular safety comparison in a high-risk population, not evidence of cardiovascular benefit or the entire glycemic-efficacy program.1

    Reviewed study record

    LIXIPARK: exploratory Parkinson trial

    Design

    Randomized, double-blind, placebo-controlled phase 2 trial with 12 months of treatment and a two-month washout.2

    Population

    156 people with early Parkinson disease were randomized while receiving stable symptomatic therapy.2

    Outcomes reported

    The between-group difference in motor-score change at 12 months was 3.08 points favoring lixisenatide. Nausea occurred in 46% and vomiting in 13% of active-group participants.2

    Limitations

    The primary assessment was in the on-medication state. A small phase 2 study cannot establish disease modification, long-term benefit or safety; larger trials are required.2

    Reviewed source set

    1. PubMed · 26630143Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. ↗PubMed PMID 26630143 · EFetch XML reviewed 2026-09-15 · payload SHA-256 115be31c54d4952d6d390218d4c3015c727c520d819e34874e529579c32c2176
      No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1056/nejmoa1509225. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
    2. PubMed · 38598572Trial of Lixisenatide in Early Parkinson's Disease. ↗PubMed PMID 38598572 · EFetch XML reviewed 2026-09-15 · payload SHA-256 1c89844dd46e395e8dfdf02f0b578335e189cb034eb66edd1a1a3f0fb7c169f7
      No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1056/nejmoa2312323. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
    Explore status sources, recent additions, and coverage gaps

    Living status brief

    What is the current status of Lixisenatide?

    U.S. label record. The cited DailyMed label identifies Lixisenatide 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 July 22, 2026. This answer changes only through the profile’s visible version and correction history.

    64Dated records34PubMed records6Trial records24Regulatory records

    Evidence present

    What records are connected here?

    Evidence lanes
    3
    Source years
    12
    Drugs@FDA applications
    1

    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?

    Literature metadata · source date July 30, 2026

    PubMed record PMID 39604042↗Added to PeptideScanner August 10, 2026

    Coverage gaps

    What remains unknown or unsupported?

    PeptideScanner currently has no selected safety records connected to this profile. That is a collection gap, not evidence that no such records exist.

    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.

    Open the complete timeline →Browse all connected recordsFollow via RSS
    Explore the Evidence Map and record counts

    Evidence Map v1

    What kinds of records connect to Lixisenatide?

    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.

    64Selected dated records
    66Connected citations
    12Populated source years2015–2026
    3/4Record lanes present
    Clinical trials6Open matching records →Literature metadata34Open matching records →Regulatory24Open matching records →Safety0No selected dated records

    Registered human studies

    Trial composition

    2 of 6 selected trial records include at least one phase value; 2 of 6 include a status value in the retained structured contract.

    25 public history versions connect to 5 of these trial records across 10 submitted years. Open the record-history collection →

    PhasesNot applicable 1Phase 4 1
    Status at observationCompleted 2

    A phase value is unavailable here for 4 selected records; this is not counted as “no phase.”

    A status value is unavailable here for 4 selected records; this is not counted as a trial status.

    PubMed bibliography

    Publication composition

    14 of 34 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

    Publication typesJournal Article 11Research Support, Non-U.S. Gov't 5Comment 3Letter 3Clinical Trial, Phase II 1Clinical Trial, Phase III 1Comparative Study 1Network Meta-Analysis 1Randomized Controlled Trial 1Review 1Systematic Review 1

    Bibliography fields unavailable here for 20 selected records; the records remain visible as metadata observations.

    Regulatory and publication surfaces

    What is structurally connected?

    Drugs@FDA applications
    1
    FDA Federal Register documents
    3
    DailyMed SPL versions
    20
    Canonical profile
    Published
    Profile structured data
    Published
    Linked dated records
    64

    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

    Research hub

    Explore the Lixisenatide evidence record

    Open all 64 records →
    64Dated records
    3Evidence types
    64Cited public sources
    12Source years

    Change ledger

    Recently changed for Lixisenatide

    Open all 66 events →

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

    Record added

    ClinicalTrials.gov record NCT02745470

    PeptideScanner retained ClinicalTrials.gov record NCT02745470 at 2026-07-30T21:22:00.254Z. Its registry update date was 2017-11-29, and PeptideScanner's reviewed identity mapping was lixisenatide.

    PeptideScanner change date
    September 9, 2026
    Cited source date
    November 29, 2017
    Evidence lane
    Clinical trials
    Open the cited record →
    Cited source
    Record added

    Lixisenatide DailyMed SPL version 1

    DailyMed lists Structured Product Labeling version 1 for the reviewed Lixisenatide label family with a published date of 2016-11-22. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

    PeptideScanner change date
    August 22, 2026
    Cited source date
    November 22, 2016
    Evidence lane
    Regulatory
    Open the cited record →
    Cited source

    Official-source collections

    Source records for Lixisenatide

    Open the full research atlas →
    PubMed34

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

    Journal Article (11)Research Support, Non-U.S. Gov't (5)Comment (3)
    1. Poly(l-threonine-co-l-threonine Succinate) Thermogels for Sustained Release of Lixisenatide.Biomacromolecules · 2024 07 01
    2. Insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) compared with premix or addition of meal-time insulin to basal insulin in people with type 2 diabetes: A systematic review and Bayesi…Diabetes, obesity & metabolism · 2020 09 03
    3. Glycaemic target attainment in people with Type 2 diabetes treated with insulin glargine/lixisenatide fixed-ratio combination: a post hoc analysis of the LixiLan-O and LixiLan-L trials.Diabetic medicine : a journal of the British Diabetic Association · 2019 11 26
    Explore all selected literature →
    ClinicalTrials.gov6

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

    Completed history (11)Recruiting history (8)Not Yet Recruiting history (3)
    Completed at observation (6)
    Diabetes Mellitus (1)Type 2 Diabetes (1)Not applicable (1)Phase 4 (1)Completed (2)
    Lixisenatide · Drug (1)Lixisenatide · Other (1)
    1. NCT03439943Registry update November 28, 2025 · completed at observation
    2. NCT02049034Registry update December 16, 2024 · completed at observation
    3. NCT02640118Registry update May 7, 2020 · completed at observation
    Explore all selected trial records →Explore all public record history →
    DailyMed SPL history20

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

    1. SPL version 25Published 2026-03-20 · ZIP SHA-256 e0f67a6ccd0f…
    2. SPL version 23Published 2025-08-01 · ZIP SHA-256 a8b9de04de70…
    3. SPL version 22Published 2025-06-13 · ZIP SHA-256 9b3ef7156a69…
    4. SPL version 19Published 2024-11-14 · ZIP SHA-256 af0908969b3e…
    5. SPL version 18Published 2023-10-12 · ZIP SHA-256 8ae271652824…
    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 December 15, 2015 to July 30, 2026.

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    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.

    Glucagon12 shared source years308 dated records · 4 evidence typesLeuprolide12 shared source years215 dated records · 4 evidence typesLiraglutide12 shared source years167 dated records · 4 evidence typesOctreotide12 shared source years160 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 Lixisenatide 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. Literature metadata

      PubMed record PMID 39604042↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 39604042 at 2026-07-30T16:31:16.748Z. PubMed recorded a metadata revision date of 2026-07-30 and an Entrez history date of 2024-11-27. PeptideScanner associated this retained record with the identity slug lixisenatide. These dates describe PubMed metadata history, not the article's original publication date.↗

    2. Literature metadata

      PubMed record PMID 38870730↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 38870730 at 2026-08-10T18:13:32.367Z. PubMed recorded a metadata revision date of 2026-07-02 and an Entrez history date of 2024-06-13. PeptideScanner associated this retained record with the identity slug lixisenatide. These dates describe PubMed metadata history, not the article's original publication date.↗

    3. Literature metadata

      PubMed record PMID 38685598↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 38685598 at 2026-07-30T16:14:06.932Z. PubMed recorded a metadata revision date of 2026-06-18 and an Entrez history date of 2024-04-30. PeptideScanner associated this retained record with the identity slug lixisenatide. These dates describe PubMed metadata history, not the article's original publication date.↗

    4. Literature metadata

      PubMed record PMID 38877681↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 38877681 at 2026-07-30T16:20:38.897Z. PubMed recorded a metadata revision date of 2026-05-31 and an Entrez history date of 2024-06-15. PeptideScanner associated this retained record with the identity slug lixisenatide. These dates describe PubMed metadata history, not the article's original publication date.↗

    5. Literature metadata

      PubMed record PMID 39407425↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 39407425 at 2026-07-30T16:20:39.038Z. PubMed recorded a metadata revision date of 2026-05-31 and an Entrez history date of 2024-10-16. PeptideScanner associated this retained record with the identity slug lixisenatide. These dates describe PubMed metadata history, not the article's original publication date.↗

    6. Literature metadata

      PubMed record PMID 22564709↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 22564709 at 2026-07-30T16:20:34.419Z. PubMed recorded a metadata revision date of 2026-05-18 and an Entrez history date of 2012-05-09. PeptideScanner associated this retained record with the identity slug lixisenatide. These dates describe PubMed metadata history, not the article's original publication date.↗

    7. Literature metadata

      PubMed record PMID 39157869↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 39157869 at 2026-07-30T16:23:36.341Z. PubMed recorded a metadata revision date of 2026-03-23 and an Entrez history date of 2024-08-19. PeptideScanner associated this retained record with the identity slug lixisenatide. These dates describe PubMed metadata history, not the article's original publication date.↗

    8. Regulatory

      Lixisenatide DailyMed SPL version 25↗

      DailyMed lists Structured Product Labeling version 25 for the reviewed Lixisenatide label family with a published date of 2026-03-20. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.↗

    9. Literature metadata

      PubMed record PMID 41623754↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 41623754 at 2026-07-30T16:25:14.225Z. PubMed recorded a metadata revision date of 2026-02-04 and an Entrez history date of 2026-02-02. PeptideScanner associated this retained record with the identity slug lixisenatide. These dates describe PubMed metadata history, not the article's original publication date.↗

    10. Literature metadata

      PubMed record PMID 25012990↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 25012990 at 2026-07-30T16:30:52.644Z. PubMed recorded a metadata revision date of 2026-01-28 and an Entrez history date of 2014-07-12. PeptideScanner associated this retained record with the identity slug lixisenatide. These dates describe PubMed metadata history, not the article's original publication date.↗

    11. Literature metadata

      PubMed record PMID 25055456↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 25055456 at 2026-07-30T16:30:52.649Z. PubMed recorded a metadata revision date of 2026-01-28 and an Entrez history date of 2014-07-25. PeptideScanner associated this retained record with the identity slug lixisenatide. These dates describe PubMed metadata history, not the article's original publication date.↗

    12. Literature metadata

      PubMed record PMID 25115916↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 25115916 at 2026-07-30T16:30:52.653Z. PubMed recorded a metadata revision date of 2026-01-28 and an Entrez history date of 2014-08-14. PeptideScanner associated this retained record with the identity slug lixisenatide. These dates describe PubMed metadata history, not the article's original publication date.↗

    Public beta · Selective source coverageNot medical advice · No dosing or purchasing guidance