U.S. label recordMetabolic

Exenatide

A GLP-1 receptor agonist. This profile cites a U.S. label record.

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

Profile update · July 27, 2026

We rewrote the profile summary to describe the cited public record more directly. The cited sources and status did not change. 1

This version supersedes public version 1.

Start here

The evidence at a glance

What is its status in the cited records?

U.S. label record. The cited DailyMed label identifies Exenatide 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 August 19, 2026 · Review version 1.

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

A bounded review of two randomized placebo-controlled trials in type 2 diabetes: one short monotherapy trial and one large cardiovascular-outcomes trial.

What the reviewed sources report

The short monotherapy trial reported improved glycated hemoglobin and weight measures. The larger outcomes trial established cardiovascular noninferiority but did not meet its superiority criterion for major cardiovascular events.

What remains unresolved?

  • Which populations, if any, have durable patient-important benefits beyond glycemic control, and how do outcomes change after treatment discontinuation?

Read study designs, results, limitations, and sources →

What does the U.S. product label say?

Exenatide injection · Read September 15, 2026 · Preserved label summary 1

Which population and use does the label cover?

This injection label covers glycemic control alongside diet and exercise in adults with type 2 diabetes. Its formulation-specific account does not substitute for extended-release exenatide labeling. Label: 1 ↗

Which safety limits matter?

Contraindications include severe hypersensitivity and prior exenatide-induced immune-mediated thrombocytopenia. Warnings address pancreatitis, hypoglycemia with insulin or insulin secretagogues, kidney injury from volume depletion, severe gastrointestinal reactions, antibodies, potentially fatal bleeding from immune-mediated thrombocytopenia, gallbladder disease and aspiration during anesthesia or deep sedation. Label: 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.

Exenatide injection · SPL version 17 · published 2026-06-30

Label ZIP SHA-256: 3a938f95f72fa59782922c490dc415fef7aa62df9872a1da096e4bff95b65abb. Extracted XML SHA-256: 18efb84e3d03a7719a6efd35e086f73cfc27232395a36db93da5fe7334894977.

Open versioned label context data →

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

Inside the official reviews

Reviewed 2026-09-19 · Preserved version 1

The original trials tested add-on diabetes treatment

EMA’s original Byetta assessment evaluated exenatide added to existing glucose-lowering therapy in type 2 diabetes. HbA1c was the principal endpoint; weight change was a separate outcome. This is not the later extended-release or cardiovascular-outcomes evidence. EMA PDF pp. 25, 27 ↗

More findings, study links and document coverage

The insulin comparisons had an important limitation

Two active-comparator trials met the prespecified HbA1c noninferiority margin. EMA noted their open-label design and the possibility that insulin treatment had not been fully optimized, limiting claims that one treatment was better overall. EMA PDF pp. 25 ↗

Extension results require caution

EMA warned that more than 80% of extension participants withdrew or discontinued for administrative reasons after week 52. Favorable results among those remaining cannot alone establish durable benefit for everyone originally enrolled. EMA PDF pp. 25 ↗

Safety depends on accompanying treatment and follow-up

The review identifies nausea and vomiting as common problems and hypoglycemia particularly with sulfonylureas. Mean exposure was under a year, with limited experience in older people and impaired kidney function. EMA PDF pp. 26 ↗

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.

  • Byetta : EPAR - Scientific Discussion ↗

    Selected sections reviewed · ema-36540 · Document/feed date: 2006-12-15

    The undated initial scientific discussion names the product. Application identity comes from the separately pinned EMA medicine record, and the date is the documents-feed first-publication date, not an adoption date.

    Verified: Byetta · EMEA/H/C/000698 · EMA first-publication date 2006-12-15. Product identity checked on PDF pp. 1.

    The undated PDF does not print the application number. The application is reconciled separately against EMA medicine record EMEA/H/C/000698 ↗, retrieved 2026-09-15. Its first-publication date is not an assessment-adoption date.

    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, 25, 26, 27 of 27. SHA-256: 406dfeecb0b57c3036d836ebf625e6aad6182143b50820c441500b79c3a2d1df.

    Feed-listed application (not a verified association): EMEA/H/C/000698.

Remaining work

  • Review the separate Bydureon extended-release assessment and EXSCEL cardiovascular program.
  • Reconcile later safety variations and full-text trial reports with their original study populations.

Open versioned document coverage and study pins →

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

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

2851 retrieved · 2 included · 0 excluded · 2849 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Exenatide"[Title/Abstract]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T10:59:08.375704+00:00 · HTTP 200 · SHA-256 bf4b3c2307fc2733a5ec58b71a0879a8b2bb848500389d471d8e506301e3e0af.

  • 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.
  • PMID18803987 has an ErratumIn relation without a notice PMID in the retrieved record; notice identity and effects remain unresolved.

Showing 25 of 2851 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 28910237 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT01144338.
    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 63ec335a3a836425cbeda76243629bf58816c0c94abb17e82892e75e64dd09ce.

  2. PubMed 18803987 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: exenatide-PMID18803987-registry-linkage-unresolved.
    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 46630cea7e348965315f0b3262be9855bfc819b39a67396e405cd68462493e1e.

    • PubMed links an erratum: Clin Ther. 2008 Oct;30(10):1937. Impact on the selected study summary remains unresolved.
  3. PubMed 42730869 — not screened: Name-query match awaiting clinical eligibility screening.
  4. PubMed 42725235 — not screened: Name-query match awaiting clinical eligibility screening.
  5. PubMed 42721371 — not screened: Name-query match awaiting clinical eligibility screening.
  6. PubMed 42714656 — not screened: Name-query match awaiting clinical eligibility screening.
  7. PubMed 42709517 — not screened: Name-query match awaiting clinical eligibility screening.
  8. PubMed 42695140 — not screened: Name-query match awaiting clinical eligibility screening.
  9. PubMed 42692277 — not screened: Name-query match awaiting clinical eligibility screening.
  10. PubMed 42687799 — not screened: Name-query match awaiting clinical eligibility screening.
  11. PubMed 42682267 — not screened: Name-query match awaiting clinical eligibility screening.
  12. PubMed 42675372 — not screened: Name-query match awaiting clinical eligibility screening.
  13. PubMed 42669385 — not screened: Name-query match awaiting clinical eligibility screening.
  14. PubMed 42666495 — not screened: Name-query match awaiting clinical eligibility screening.
  15. PubMed 42654342 — not screened: Name-query match awaiting clinical eligibility screening.
  16. PubMed 42644866 — not screened: Name-query match awaiting clinical eligibility screening.
  17. PubMed 42609010 — not screened: Name-query match awaiting clinical eligibility screening.
  18. PubMed 42603384 — not screened: Name-query match awaiting clinical eligibility screening.
  19. PubMed 30000037 — not screened: Name-query match awaiting clinical eligibility screening.
  20. PubMed 42594084 — not screened: Name-query match awaiting clinical eligibility screening.
  21. PubMed 42585299 — not screened: Name-query match awaiting clinical eligibility screening.
  22. PubMed 42584027 — not screened: Name-query match awaiting clinical eligibility screening.
  23. PubMed 42570075 — not screened: Name-query match awaiting clinical eligibility screening.
  24. PubMed 42539351 — not screened: Name-query match awaiting clinical eligibility screening.
  25. PubMed 42536830 — 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.

5 retrieved · 5 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

products.active_ingredients.name:"EXENATIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:14.393156+00:00 · HTTP 200 · SHA-256 8fff82f2178bd092ac447731cdde48204751a85a4d031c77767992c6e6ad778f.

  • 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 5 of 5 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. FDA ANDA206697 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: EXENATIDE SYNTHETIC.
  2. FDA NDA021773 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: EXENATIDE SYNTHETIC.
  3. FDA NDA022200 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: EXENATIDE SYNTHETIC.
  4. FDA NDA021919 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: EXENATIDE SYNTHETIC.
  5. FDA NDA209210 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: EXENATIDE SYNTHETIC.

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: ["Exenatide"]

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/002020 — include: EMA feed product Bydureon; reported status: Authorised. Exact indication and decision documents remain unappraised.
  2. EMA EMEA/H/C/000698 — include: EMA feed product Byetta; 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.

44 retrieved · 29 included · 0 excluded · 15 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Exenatide"]

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

  1. EMA 6123 — include: Document linked by EMA product number; content unappraised. Byetta : EPAR - Summary for the public
  2. EMA 11126 — include: Document linked by EMA product number; content unappraised. Bydureon : EPAR - All Authorised presentations
  3. EMA 12068 — include: Document linked by EMA product number; content unappraised. Bydureon-H-C-2020-PSUV-0024 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  4. EMA 12420 — include: Document linked by EMA product number; content unappraised. Byetta : EPAR - All Authorised presentations
  5. EMA 14627 — include: Document linked by EMA product number; content unappraised. Byetta : EPAR - Procedural steps taken before authorisation
  6. EMA 19721 — include: Document linked by EMA product number; content unappraised. Bydureon-H-C-2020-PSUV-0014 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  7. EMA 22590 — include: Document linked by EMA product number; content unappraised. Bydureon-H-C-002020-II-0045 : EPAR - Assessment report - Variation
  8. EMA 23204 — include: Document linked by EMA product number; content unappraised. Bydureon : EPAR - Summary for the public
  9. EMA 25728 — include: Document linked by EMA product number; content unappraised. Byetta-H-C-698-II-0021 : EPAR - Assessment Report - Variation
  10. EMA 26196 — include: Document linked by EMA product number; content unappraised. Bydureon-H-C-2020-II-0041 : EPAR - Assessment Report - Variation
  11. EMA 29015 — include: Document linked by EMA product number; content unappraised. Byetta-H-C-698-PSUV-0045 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  12. EMA 29706 — include: Document linked by EMA product number; content unappraised. Bydureon-H-C-PSUSA-00009147-201503 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  13. EMA 30099 — include: Document linked by EMA product number; content unappraised. Byetta-H-C-698-II-0029 : EPAR - Assessment Report - Variation
  14. EMA 30953 — include: Document linked by EMA product number; content unappraised. Bydureon : EPAR - Public assessment report
  15. EMA 31353 — include: Document linked by EMA product number; content unappraised. Bydureon-H-C-2020-PSU-0014 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  16. EMA 31694 — include: Document linked by EMA product number; content unappraised. Bydureon-H-C-2020-PSUV-0018 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  17. EMA 36540 — include: Document linked by EMA product number; content unappraised. Byetta : EPAR - Scientific Discussion
  18. EMA 37951 — include: Document linked by EMA product number; content unappraised. Byetta-PSUSA-00009147-201503 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  19. EMA 42298 — include: Document linked by EMA product number; content unappraised. Bydureon-H-C-2020-X-0048-G : EPAR - Assessment Report - Extension
  20. EMA 50315 — include: Document linked by EMA product number; content unappraised. Bydureon-H-C-PSUSA-00009147-202003 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  21. EMA 50316 — include: Document linked by EMA product number; content unappraised. Bydureon-H-C-2020-P46-028 : EPAR - Assessment report
  22. EMA 50318 — include: Document linked by EMA product number; content unappraised. Byetta-PSUSA-00009147-202003 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  23. EMA 55742 — include: Document linked by EMA product number; content unappraised. Bydureon : EPAR - Risk management plan summary
  24. EMA 60626 — include: Document linked by EMA product number; content unappraised. Byetta-H-C-698-P46-048 : EPAR - Assessment report
  25. EMA 58772 — include: Document linked by EMA product number; content unappraised. Byetta : EPAR - Risk-management-plan summary

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.

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: ["Exenatide"]

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 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 EU/3/23/2793 — include: EMA orphan feed identifies exenatide; designation status: Positive. Orphan designation is not marketing authorization.
  2. EMA EU/3/16/1629 — include: EMA orphan feed identifies exenatide; designation status: Positive. Orphan designation is not marketing authorization.

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.

408 retrieved · 0 included · 0 excluded · 408 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Exenatide" OR "Bydureon" OR "Byetta"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:18.867572+00:00 · HTTP 200 · SHA-256 32803bfbb19ac7301cb904379bdac15b37a5925c5c3afb6611223b7694a87b4f.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:20.520567+00:00 · HTTP 200 · SHA-256 fbee42120aed96b2e22fd2a3367c92b960a17981813f66997a692490c2afa701.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:21.909291+00:00 · HTTP 200 · SHA-256 234248551ce36158fa018f9d2e69be58cbbbc5f551b96ba83794c4ddbde57d5c.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:23.487585+00:00 · HTTP 200 · SHA-256 0653bdc8509bf3d5ac0af3fef3a971f8810fd9460be9c03b45ba21b2e94a73e8.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:24.421706+00:00 · HTTP 200 · SHA-256 8866f4f470bab63baa98923553de5cdf16e3a66c00c0c883b7218a0f63cf7037.

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

  1. ClinicalTrials.gov NCT00569907 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  2. ClinicalTrials.gov NCT00775684 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  3. ClinicalTrials.gov NCT01208649 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  4. ClinicalTrials.gov NCT04268862 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  5. ClinicalTrials.gov NCT02170324 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  6. ClinicalTrials.gov NCT01602913 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  7. ClinicalTrials.gov NCT02325960 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  8. ClinicalTrials.gov NCT00679042 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  9. ClinicalTrials.gov NCT02586831 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  10. ClinicalTrials.gov NCT01934816 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  11. ClinicalTrials.gov NCT01677104 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  12. ClinicalTrials.gov NCT01302327 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  13. ClinicalTrials.gov NCT00097500 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  14. ClinicalTrials.gov NCT02847403 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  15. ClinicalTrials.gov NCT04615910 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  16. ClinicalTrials.gov NCT02162550 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  17. ClinicalTrials.gov NCT02584582 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  18. ClinicalTrials.gov NCT04159766 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  19. ClinicalTrials.gov NCT00744224 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  20. ClinicalTrials.gov NCT00845182 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  21. ClinicalTrials.gov NCT05034783 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  22. ClinicalTrials.gov NCT02541734 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  23. ClinicalTrials.gov NCT01511393 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  24. ClinicalTrials.gov NCT02793154 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  25. ClinicalTrials.gov NCT02288273 — 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 Exenatide?

Manually reviewed August 19, 2026 · version 1

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

A bounded review of two randomized placebo-controlled trials in type 2 diabetes: one short monotherapy trial and one large cardiovascular-outcomes trial.21

Bottom line from this bounded source set

The short monotherapy trial reported improved glycated hemoglobin and weight measures. The larger outcomes trial established cardiovascular noninferiority but did not meet its superiority criterion for major cardiovascular events.21

Reviewed study record

Monotherapy trial

Design

A double-blind randomized placebo-controlled trial assessed glycemic measures, weight, and tolerability over 24 weeks.2

Population

The trial included 232 adults with type 2 diabetes that was inadequately controlled with diet and exercise and who had not used antidiabetic drugs.2

Outcomes reported

Mean glycated-hemoglobin reductions were 0.7 and 0.9 percentage points in the two exenatide groups and 0.2 points with placebo. Mean weight reductions were 2.8 and 3.1 kilograms versus 1.4 kilograms.2

Limitations

The trial was small and 24 weeks long, and its surrogate and weight outcomes do not establish longer-term clinical benefit or rare harms.2

Reviewed study record

EXSCEL cardiovascular-outcomes trial

Design

A sponsor-funded randomized placebo-controlled cardiovascular-outcomes trial followed participants for a median of 3.2 years alongside usual care.1

Population

The trial randomized 14,752 adults with type 2 diabetes; 73.1% had previous cardiovascular disease.1

Outcomes reported

The primary cardiovascular outcome occurred in 11.4% of the exenatide group and 12.2% of the placebo group. The comparison met noninferiority for safety but not superiority for efficacy.1

Limitations

The pragmatic trial included participants with and without prior cardiovascular disease, and its borderline superiority result should not be reframed as proof of cardiovascular benefit.1

Reviewed source set

  1. PubMed · 28910237Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes ↗PubMed PMID 28910237 · EFetch XML reviewed 2026-08-19 · payload SHA-256 63ec335a3a836425cbeda76243629bf58816c0c94abb17e82892e75e64dd09ce
    No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1056/nejmoa1612917. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  2. PubMed · 18803987Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study ↗PubMed PMID 18803987 · EFetch XML reviewed 2026-08-19 · payload SHA-256 46630cea7e348965315f0b3262be9855bfc819b39a67396e405cd68462493e1e
    No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1016/j.clinthera.2008.08.006. 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 Exenatide?

U.S. label record. The cited DailyMed label identifies Exenatide 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.

Evidence present

What records are connected here?

Evidence lanes
3
Source years
20
Drugs@FDA applications
5

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

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.

Explore the Evidence Map and record counts

Evidence Map v1

What kinds of records connect to Exenatide?

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.

119Selected dated records
120Connected citations
20Populated source years2005–2026
3/4Record lanes present

Registered human studies

Trial composition

3 of 50 selected trial records include at least one phase value; 4 of 50 include a status value in the retained structured contract.

389 public history versions connect to 48 of these trial records across 21 submitted years. Open the record-history collection →

PhasesPhase 4 2Not applicable 1
Status at observationCompleted 3Recruiting 1

A phase value is unavailable here for 47 selected records; this is not counted as “no phase.”

A status value is unavailable here for 46 selected records; this is not counted as a trial status.

PubMed bibliography

Publication composition

25 of 49 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

Publication typesJournal Article 22Randomized Controlled Trial 5Research Support, Non-U.S. Gov't 5Multicenter Study 4Case Reports 2Clinical Trial 2Comparative Study 2Letter 2Clinical Trial, Phase II 1Comment 1Editorial 1Patient Education Handout 1Research Support, N.I.H., Extramural 1Research Support, U.S. Gov't, Non-P.H.S. 1Review 1

Bibliography fields unavailable here for 24 selected records; the records remain visible as metadata observations.

Regulatory and publication surfaces

What is structurally connected?

Drugs@FDA applications
5
FDA Federal Register documents
10
DailyMed SPL versions
5
Canonical profile
Published
Profile structured data
Published
Linked dated records
119

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 Exenatide evidence record

Open all 119 records →
119Dated records
3Evidence types
119Cited public sources
20Source years

Change ledger

Recently changed for Exenatide

Open all 120 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 NCT01364584

PeptideScanner retained ClinicalTrials.gov record NCT01364584 at 2026-07-30T19:10:42.711Z. Its registry update date was 2023-07-12, and PeptideScanner's reviewed identity mapping was exenatide.

PeptideScanner change date
September 9, 2026
Cited source date
July 12, 2023
Evidence lane
Clinical trials
Record added

ClinicalTrials.gov record NCT02981069

PeptideScanner retained ClinicalTrials.gov record NCT02981069 at 2026-07-30T19:10:42.759Z. Its registry update date was 2023-07-20, and PeptideScanner's reviewed identity mapping was exenatide.

PeptideScanner change date
September 9, 2026
Cited source date
July 20, 2023
Evidence lane
Clinical trials
Record added

Development of Chondroitin Sulfate ‑ Stabilized PLGA Microspheres of Exenatide via Polarity Gradient Extraction.

PubMed lists PMID 42709517 in Pharmaceutical development and technology as Journal Article, with publication-date metadata of 2026-09-08 (day precision). PeptideScanner associated the retained record with the identity slug exenatide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

PeptideScanner change date
September 9, 2026
Cited source date
September 8, 2026
Evidence lane
Literature metadata

Official-source collections

Source records for Exenatide

Open the full research atlas →
PubMed49

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

  1. Development of Chondroitin Sulfate ‑ Stabilized PLGA Microspheres of Exenatide via Polarity Gradient Extraction.Pharmaceutical development and technology · 2026 09 08
  2. Expenditures for medicaid patients treated with exenatide compared with other diabetes management regimens.The American journal of managed care · 2012 Sep
  3. Combination exenatide-sitagliptin therapy used with glipizide in a patient with type 2 diabetes mellitus.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2012 Jun 15
Explore all selected literature →
ClinicalTrials.gov50

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

  1. NCT05663515Registry update August 4, 2026 · current at observation
  2. NCT02860923Registry update May 22, 2026 · completed at observation
  3. NCT05482789Registry update April 20, 2026 · current at observation
Explore all selected trial records →Explore all public record history →
Drugs@FDA5

Original-submission application metadata connected by exact reviewed active-ingredient names.

  1. ANDA206697Full FDA chronology · original submission status AP 2024-11-19
  2. NDA209210Full FDA chronology · original submission status AP 2017-10-20
  3. NDA022200Full FDA chronology · original submission status AP 2012-01-27
  4. NDA021919Full FDA chronology · original submission status AP 2009-10-30
  5. NDA021773Full FDA chronology · original submission status AP 2005-04-28
Explore all selected FDA applications →Explore 87 dated submissions and 152 documents for Exenatide →
DailyMed SPL history5

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

  1. SPL version 17Published 2026-06-30 · ZIP SHA-256 3a938f95f72f…
  2. SPL version 16Published 2026-01-12 · ZIP SHA-256 d3e0adf04135…
  3. SPL version 13Published 2025-08-13 · ZIP SHA-256 2e382ab2039e…
  4. SPL version 12Published 2025-08-07 · ZIP SHA-256 bf1b181a3330…
  5. SPL version 11Published 2024-11-25 · ZIP SHA-256 65b5ffdc2630…
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 April 28, 2005 to September 8, 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.

Octreotide20 shared source years160 dated records · 4 evidence typesLeuprolide19 shared source years215 dated records · 4 evidence typesTeriparatide19 shared source years149 dated records · 3 evidence typesLiraglutide17 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 Exenatide 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

    Development of Chondroitin Sulfate ‑ Stabilized PLGA Microspheres of Exenatide via Polarity Gradient Extraction.

    PubMed lists PMID 42709517 in Pharmaceutical development and technology as Journal Article, with publication-date metadata of 2026-09-08 (day precision). PeptideScanner associated the retained record with the identity slug exenatide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

  2. Regulatory

    Federal Register notice 2026-16998

    The Federal Register published notice 2026-16998, attributed to FDA and its parent HHS department, on 2026-08-20. Its official title is “Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal,” and PeptideScanner's exact reviewed identity mapping connects the document to Exenatide.

  3. Literature metadata

    PubMed record PMID 30974038

    PeptideScanner retained PubMed bibliographic metadata for PMID 30974038 at 2026-08-10T10:49:06.835Z. PubMed recorded a metadata revision date of 2026-08-08 and an Entrez history date of 2019-04-12. PeptideScanner associated this retained record with the identity slug exenatide. These dates describe PubMed metadata history, not the article's original publication date.

  4. Clinical trials

    ClinicalTrials.gov record NCT05663515

    PeptideScanner retained ClinicalTrials.gov record NCT05663515 at 2026-08-13T05:52:27.024Z. Its registry update date was 2026-08-04, and PeptideScanner's reviewed identity mapping was exenatide.

  5. Literature metadata

    PubMed record PMID 41364402

    PeptideScanner retained PubMed bibliographic metadata for PMID 41364402 at 2026-08-10T18:13:38.016Z. PubMed recorded a metadata revision date of 2026-07-26 and an Entrez history date of 2025-12-09. PeptideScanner associated this retained record with the identity slug exenatide. These dates describe PubMed metadata history, not the article's original publication date.

  6. Literature metadata

    PubMed record PMID 42171611

    PeptideScanner retained PubMed bibliographic metadata for PMID 42171611 at 2026-08-10T18:13:50.652Z. PubMed recorded a metadata revision date of 2026-07-26 and an Entrez history date of 2026-05-22. PeptideScanner associated this retained record with the identity slug exenatide. These dates describe PubMed metadata history, not the article's original publication date.

  7. Literature metadata

    PubMed record PMID 42290292

    PeptideScanner retained PubMed bibliographic metadata for PMID 42290292 at 2026-08-10T18:13:52.268Z. PubMed recorded a metadata revision date of 2026-07-26 and an Entrez history date of 2026-06-15. PeptideScanner associated this retained record with the identity slug exenatide. These dates describe PubMed metadata history, not the article's original publication date.

  8. Literature metadata

    PubMed record PMID 41865922

    PeptideScanner retained PubMed bibliographic metadata for PMID 41865922 at 2026-08-10T18:13:44.869Z. PubMed recorded a metadata revision date of 2026-07-13 and an Entrez history date of 2026-03-22. PeptideScanner associated this retained record with the identity slug exenatide. These dates describe PubMed metadata history, not the article's original publication date.

  9. Literature metadata

    PubMed record PMID 41597428

    PeptideScanner retained PubMed bibliographic metadata for PMID 41597428 at 2026-07-30T16:11:44.888Z. PubMed recorded a metadata revision date of 2026-07-01 and an Entrez history date of 2026-01-28. PeptideScanner associated this retained record with the identity slug exenatide. These dates describe PubMed metadata history, not the article's original publication date.

  10. Regulatory

    Exenatide DailyMed SPL version 17

    DailyMed lists Structured Product Labeling version 17 for the reviewed Exenatide label family with a published date of 2026-06-30. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

  11. Literature metadata

    PubMed record PMID 39919773

    PeptideScanner retained PubMed bibliographic metadata for PMID 39919773 at 2026-07-30T16:14:10.828Z. PubMed recorded a metadata revision date of 2026-06-25 and an Entrez history date of 2025-02-07. PeptideScanner associated this retained record with the identity slug exenatide. These dates describe PubMed metadata history, not the article's original publication date.

  12. Literature metadata

    PubMed record PMID 42330995

    PeptideScanner retained PubMed bibliographic metadata for PMID 42330995 at 2026-07-30T16:14:19.343Z. PubMed recorded a metadata revision date of 2026-06-25 and an Entrez history date of 2026-06-22. PeptideScanner associated this retained record with the identity slug exenatide. These dates describe PubMed metadata history, not the article's original publication date.