U.S. label recordMetabolic

Glucagon

Related names in cited records: Gvoke VialDx

A peptide hormone. The cited U.S. label distinguishes Gvoke for severe hypoglycemia from Gvoke VialDx for diagnostic use.

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

Correction · September 15, 2026

The previous summary described this only as an emergency-treatment label. We now distinguish Gvoke's severe-hypoglycemia indication from Gvoke VialDx's diagnostic indication in the same cited label. 1

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 label describes subcutaneous Gvoke for severe hypoglycemia in people with diabetes aged two years and older, and intravenous Gvoke VialDx as a diagnostic aid in adults. The product, route and indication must remain distinct.

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.

Three selected reports examine glucagon rescue formulations in diabetes. Nasal, intramuscular and ready-to-use subcutaneous products have different delivery contexts; related analogues and diagnostic uses require separate assessment.

What the reviewed sources report

Controlled studies found high recovery rates after experimentally induced hypoglycemia. A small uncontrolled study also reported recovery during spontaneous episodes. Laboratory recovery times and trained-caregiver observations do not establish equivalent performance in every emergency.

What remains unresolved?

  • How do current product labels distinguish rescue and diagnostic uses and age-specific indications?
  • What do larger real-world studies establish about failures, harms and untrained-caregiver use?

Read study designs, results, limitations, and sources →

What does the U.S. product label say?

Gvoke and Gvoke VialDx · Read September 15, 2026 · Preserved label summary 1

Which population and use does the label cover?

The shared label separates Gvoke for severe hypoglycemia in adults and children aged two years and older with diabetes from Gvoke VialDx as a diagnostic aid during gastrointestinal radiologic examinations in adults. These are different product uses; the diagnostic vial is not the severe-hypoglycemia presentation. Label: 1.1, 1.2 ↗

Which safety limits matter?

Contraindications include pheochromocytoma, insulinoma and prior hypersensitivity; diagnostic use also contraindicates glucagonoma. Warnings address serious allergic reactions, blood-pressure increases, hypoglycemia in specific tumor settings, reduced efficacy when liver glycogen is depleted, and a skin reaction reported with continuous infusion. Diagnostic use has additional warnings about hyperglycemia and increased cardiac demand, blood pressure and heart rate. 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.

GVOKE VIALDX (glucagon) injection, solution · SPL version 2 · published 2026-07-09

Label ZIP SHA-256: 8a7eea4413fc92f6e205eb71e1c76b56e2ae78d9fe5eb31679c7319800c12d49. Extracted XML SHA-256: aaa5ae4cd4355c3558a0223bcca2f00eabc45db6667177ac9561b0b4db5c95ba.

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 pivotal question was recovery from hypoglycemia

EMA’s Ogluo review describes controlled studies of glucagon in people with diabetes. The pivotal adult endpoint was blood-glucose recovery within 30 minutes; the pediatric study was open-label. EMA PDF pp. 106, 107 ↗

More findings, study links and document coverage

Noninferiority did not mean identical recovery speed

The adult study met its noninferiority criterion, but EMA reported slower glucose recovery after administration than the reference product. Preparation time and the time measured after injection are distinct comparisons. EMA PDF pp. 107, 108 ↗

Usability studies answer a different question

Human-factors studies tested successful device use, including simulated emergencies. Their results support a usability assessment; they are not the same as observing clinical outcomes during spontaneous severe hypoglycemia. EMA PDF pp. 107, 108, 111 ↗

The formulation and population define the scope

This assessment concerns the ready-to-use Ogluo formulation and its severe-hypoglycemia indication. A real-world actual-use study was planned; that plan is not a completed result in this document. EMA PDF pp. 108, 112 ↗

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.

  • Ogluo : EPAR - Public assessment report ↗

    Selected sections reviewed · ema-50305 · Document/feed date: 2021-02-26

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

    Verified: Ogluo · EMEA/H/C/005391 · Document dated 2020-12-10. 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, 106, 107, 108, 111, 112 of 114. SHA-256: 7cd33c516e2e3f15b9de4e3d25054354e74e316483d85afa02f37ddbe1463199.

    Feed-listed application (not a verified association): EMEA/H/C/005391.

Remaining work

  • Review actual-use follow-up and separately assess other glucagon delivery systems.
  • Reconcile pediatric age groups, study timing and real emergency outcomes with current formulation-specific labels.

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

Targeted nasal, autoinjector and ready-to-use glucagon search, not the complete physiological or clinical glucagon literature. Analog medicines are separate identities.

93 retrieved · 3 included · 0 excluded · 90 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"glucagon"[Title] AND ("nasal"[Title/Abstract] OR "autoinjector"[Title/Abstract] OR "ready-to-use"[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 93 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 34620618 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT03439072; NCT02656069.
  2. PubMed 32514794 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT03339453.
  3. PubMed 29504662 — include: Selected human report; abstract and record metadata reviewed. Study families: glucagon-PMID29504662-registry-linkage-unresolved.
  4. PubMed 42557738 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  5. PubMed 42444066 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  6. PubMed 41022041 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  7. PubMed 41767683 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  8. PubMed 42041268 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  9. PubMed 40459429 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  10. PubMed 39490582 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  11. PubMed 39614598 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  12. PubMed 39341285 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  13. PubMed 37291796 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  14. PubMed 39235687 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  15. PubMed 38972099 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  16. PubMed 39086086 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  17. PubMed 38736200 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  18. PubMed 38224759 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  19. PubMed 38444629 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  20. PubMed 37867226 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  21. PubMed 38000667 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  22. PubMed 37751153 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  23. PubMed 37707700 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  24. PubMed 35533142 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  25. PubMed 37268778 — 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.

12 retrieved · 12 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

products.active_ingredients.name:"GLUCAGON"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:15.730842+00:00 · HTTP 200 · SHA-256 15763e6beef0987b8e77cb1343c9249c099e1e591ff00e5200d56c10fd3065a4.

  • 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 12 of 12 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. FDA NDA020918 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: GLUCAGON HYDROCHLORIDE.
  2. FDA ANDA071022 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: GLUCAGON HYDROCHLORIDE.
  3. FDA ANDA071023 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: GLUCAGON HYDROCHLORIDE.
  4. FDA NDA212097 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: GLUCAGON.
  5. FDA ANDA204468 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: GLUCAGON.
  6. FDA NDA201849 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: GLUCAGON HYDROCHLORIDE.
  7. FDA NDA020928 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: GLUCAGON.
  8. FDA NDA210134 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: GLUCAGON.
  9. FDA ANDA214457 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: GLUCAGON.
  10. FDA NDA012122 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: GLUCAGON HYDROCHLORIDE.
  11. FDA ANDA218813 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: GLUCAGON.
  12. FDA ANDA208086 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: GLUCAGON.

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: ["Glucagon", "Gvoke VialDx"]

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/005391 — include: EMA feed product Ogluo; reported status: Authorised. Exact indication and decision documents remain unappraised.
  2. EMA EMEA/H/C/003848 — include: EMA feed product Baqsimi; 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.

36 retrieved · 17 included · 0 excluded · 19 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Glucagon", "Gvoke VialDx"]

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

  1. EMA 46681 — include: Document linked by EMA product number; content unappraised. Baqsimi : EPAR - All authorised presentations
  2. EMA 46684 — include: Document linked by EMA product number; content unappraised. Baqsimi : EPAR - Public assessment report
  3. EMA 50302 — include: Document linked by EMA product number; content unappraised. Ogluo : EPAR - Medicine overview
  4. EMA 50304 — include: Document linked by EMA product number; content unappraised. Ogluo : EPAR - All authorised presentations
  5. EMA 50305 — include: Document linked by EMA product number; content unappraised. Ogluo : EPAR - Public assessment report
  6. EMA 50306 — include: Document linked by EMA product number; content unappraised. Ogluo : EPAR - Risk Management Plan
  7. EMA 65060 — include: Document linked by EMA product number; content unappraised. Baqsimi-H-C-003848-P46-002 : EPAR - Assessment report
  8. EMA 54196 — include: Document linked by EMA product number; content unappraised. Ogluo : EPAR - Procedural steps taken and scientific information after authorisation (archive)
  9. EMA 68321 — include: Document linked by EMA product number; content unappraised. Ogluo : EPAR – Product information - tracked changes
  10. EMA 46683 — include: Document linked by EMA product number; content unappraised. Baqsimi : EPAR - Risk management plan
  11. EMA 46682 — include: Document linked by EMA product number; content unappraised. Baqsimi : EPAR - Medicine overview
  12. EMA 51804 — include: Document linked by EMA product number; content unappraised. Baqsimi : EPAR - Procedural steps taken and scientific information after authorisation (archive)
  13. EMA 70088 — include: Document linked by EMA product number; content unappraised. Baqsimi : EPAR - Procedural steps taken and scientific information after authorisation
  14. EMA 70089 — include: Document linked by EMA product number; content unappraised. Baqsimi-VR-0000244909 : EPAR - Assessment report - Variation
  15. EMA 68320 — include: Document linked by EMA product number; content unappraised. Ogluo : EPAR - Procedural steps taken and scientific information after authorisation
  16. EMA 50303 — include: Document linked by EMA product number; content unappraised. Ogluo : EPAR - Product information
  17. EMA 46680 — include: Document linked by EMA product number; content unappraised. Baqsimi : EPAR - Product information
  18. EMA 3649 — not screened: Title-name match awaiting identity and document review. EU/3/17/1887: Public summary of opinion on orphan designation: Synthetic glucagon analogue modified to contain 7 amino acid substitutions for the treatment of congenital hyperinsulinism
  19. EMA 8202 — not screened: Title-name match awaiting identity and document review. EU/3/18/2022: Public summary of opinion on orphan designation: Glucagon analogue linked to a human immunoglobulin Fc fragment for the treatment of congenital hyperinsulinism
  20. EMA 22861 — not screened: Title-name match awaiting identity and document review. EU/3/14/1342: Public summary of opinion on orphan designation: Glucagon for the treatment of congenital hyperinsulinism
  21. EMA 35129 — not screened: Title-name match awaiting identity and document review. EU/3/01/077: Public summary of positive opinion for orphan designation of [gly2]-recombinant human glucagon-like peptide for the treatment of short-bowel syndrome
  22. EMA 41458 — not screened: Title-name match awaiting identity and document review. EU/3/12/960: Public summary of opinion on orphan designation: Glucagon for the treatment of congenital hyperinsulinism
  23. EMA 43803 — not screened: Title-name match awaiting identity and document review. EU/3/18/2091: Public summary of opinion on orphan designation: Glucagon for the treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome
  24. EMA 44117 — not screened: Title-name match awaiting identity and document review. EU/3/18/2126: Public summary of opinion on orphan designation: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment for the treatment of short bowel syndrome
  25. EMA 48608 — not screened: Title-name match awaiting identity and document review. EU/3/20/2275: Public summary of positive opinion for orphan designation of glucagon analogue linked to a human immunoglobulin Fc fragment for the treatment of insulin autoimmune syndrome

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.

11 retrieved · 3 included · 8 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Glucagon", "Gvoke VialDx"]

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 11 of 11 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA EU/3/18/2091 — include: EMA orphan feed identifies Glucagon; designation status: Positive. Orphan designation is not marketing authorization.
  2. EMA EU/3/14/1342 — include: EMA orphan feed identifies Glucagon; designation status: Positive. Orphan designation is not marketing authorization.
  3. EMA EU/3/12/960 — include: EMA orphan feed identifies Glucagon; designation status: Positive. Orphan designation is not marketing authorization.
  4. EMA EU/3/22/2619 — exclude: Different analogue, conjugate or glucagon-like peptide; the name match does not identify the unmodified catalog molecule.
  5. EMA EU/3/01/077 — exclude: Different analogue, conjugate or glucagon-like peptide; the name match does not identify the unmodified catalog molecule.
  6. EMA EU/3/21/2561 — exclude: Different analogue, conjugate or glucagon-like peptide; the name match does not identify the unmodified catalog molecule.
  7. EMA EU/3/21/2547 — exclude: Different analogue, conjugate or glucagon-like peptide; the name match does not identify the unmodified catalog molecule.
  8. EMA EU/3/17/1887 — exclude: Different analogue, conjugate or glucagon-like peptide; the name match does not identify the unmodified catalog molecule.
  9. EMA EU/3/20/2275 — exclude: Different analogue, conjugate or glucagon-like peptide; the name match does not identify the unmodified catalog molecule.
  10. EMA EU/3/18/2022 — exclude: Different analogue, conjugate or glucagon-like peptide; the name match does not identify the unmodified catalog molecule.
  11. EMA EU/3/18/2126 — exclude: Different analogue, conjugate or glucagon-like peptide; the name match does not identify the unmodified catalog molecule.

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.

3307 retrieved · 0 included · 0 excluded · 3307 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Glucagon" OR "Gvoke VialDx" OR "Ogluo" OR "Baqsimi"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:26.530661+00:00 · HTTP 200 · SHA-256 53ce793bfd14770c4b4ea148bcf9e2d3b499e19bf6e42706e63356fb1038cbc9.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:27.994705+00:00 · HTTP 200 · SHA-256 a0d04905861bd05eb846589bc2bade7070fda9993bb41c4aebb015b94f636086.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:29.699820+00:00 · HTTP 200 · SHA-256 31295a8195fa7c40c32ed3f76173019ff521b7f38439bf7693a4773758a46214.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:31.003453+00:00 · HTTP 200 · SHA-256 18013784332a5a4288ed92a5ac288ce527938c91a96a07fe30386c62ebf84728.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:32.655715+00:00 · HTTP 200 · SHA-256 dba5df28b14e01056597f901003bef1bba2912c0478af78849739b501ae4dd6b.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:34.131477+00:00 · HTTP 200 · SHA-256 0a298705ac9d09b82c473885f9c9c7fd44779d974ef3111ecd8f7685763958fc.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:35.736116+00:00 · HTTP 200 · SHA-256 c200213675d05bf94b6f2c3dc760df86ebd1021d34e57cab7cb296672bccf964.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:37.325200+00:00 · HTTP 200 · SHA-256 732833c990d5dcbc984aaf20ce8b98969ae9db886072de5137d31db6672ea30d.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:39.006627+00:00 · HTTP 200 · SHA-256 d9f5718cdfb091dd854098b49614175aab5cb4a6afcd16b2d8d1e001d0ea42e6.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:40.232218+00:00 · HTTP 200 · SHA-256 bd1120a829cd9b9dc553f1208c266ad72050938b461b501adee9bbd3d0564f5a.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:41.707445+00:00 · HTTP 200 · SHA-256 67a30d1911ed83b7b2ecf86056e8a5f4770ae517b113668f42053a105d8586c8.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:43.172565+00:00 · HTTP 200 · SHA-256 33b1d3c29fb8ec6a9f46b55a0bf126861cc46d58f98bb66e270278b7c4e6db55.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:44.515526+00:00 · HTTP 200 · SHA-256 e6842974509f5eceb6b704af274a90d13e116eb90e4feaff55e0233d8f3deb1e.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:45.819237+00:00 · HTTP 200 · SHA-256 2caca5e4133fa069591a1d6645c44058f14896eaadc896cf78d44d01098d8e5c.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:47.214142+00:00 · HTTP 200 · SHA-256 2c77ef159b4c046b8bfb6d385feea490d98162077e17d27fe541c7e781023438.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:48.489967+00:00 · HTTP 200 · SHA-256 3d38f6dd23fcf8aa8563dda343e8f9c95a191eaeca5bab9a438b5bc179f75705.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:49.848051+00:00 · HTTP 200 · SHA-256 c170ae002aec3187818bf8a43ae81e47b41df71817f10713f6546f7971422302.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:51.059675+00:00 · HTTP 200 · SHA-256 1a3e97d41e2cf35fb59382b95e9aac9f73cbedc92dbb2a02ff56479cd853e397.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:52.566788+00:00 · HTTP 200 · SHA-256 670dcac49561894294f9b28525894acfec6e04f0818cf304c6486c0d4ba9eb06.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:54.354856+00:00 · HTTP 200 · SHA-256 285683d97db61fb800060c6718baaa2b4b1f651ad9049cea7bffb91caf17ab8c.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:55.857119+00:00 · HTTP 200 · SHA-256 129b79cdef32e709eaf2155af30538785887544d3a86c8da19d664b372fe791c.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:57.247949+00:00 · HTTP 200 · SHA-256 36d520a046bc5dcddf6fe82816ca65c64d90b5ae17cac89b30a71bc507f2623c.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:58.615580+00:00 · HTTP 200 · SHA-256 b0dd4d3168ed21c0b1ea73175a5a2a71259e38f574fe453f5c2ac5c6e34c8f79.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:25:59.782164+00:00 · HTTP 200 · SHA-256 2873ae5d5290917da19ba44e198bc75d46aa6dc41ff24be32c230df81ca3f9f7.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:01.269194+00:00 · HTTP 200 · SHA-256 e2e4836bfbcdec9f1548e4d0bc5e9751ae3e25fe14f6395fb2dac5ffaca7ea63.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:02.609318+00:00 · HTTP 200 · SHA-256 09b3793d1bf6d38d356a38b42321923122bc6d965df222c41bdf0fe5d7995db8.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:04.166554+00:00 · HTTP 200 · SHA-256 acd7c8616fd6dd673e5f773b16134ccd8eb6306f7d3a1a2221220b1d9e23a34a.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:05.773992+00:00 · HTTP 200 · SHA-256 1407b2e1d59ab681dcdd223183f75289b4798a5f66241d968c899181da02b409.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:07.313798+00:00 · HTTP 200 · SHA-256 4208c7f2a8d448e68ba3920e39bc632e7a79ec646f61fcecf4a7572011850f96.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:08.675527+00:00 · HTTP 200 · SHA-256 2d280199d3bbf184bd12168fa8a8f335e82e319814ddccdd15b29bb07c9b1da0.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:09.921499+00:00 · HTTP 200 · SHA-256 a346a933e04493720f6840accbb4c0ccb6c4f5dba8f14414e3d9cf720951b9a7.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:11.507075+00:00 · HTTP 200 · SHA-256 3c4f2c133fc1a9d1dc6bc7fd9ef4f462f41697e7c650f9a878d054a965b8ecc0.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:12.863198+00:00 · HTTP 200 · SHA-256 a35a3f55c322a161c0776e6adcb49eecb87b88039510740918646559b80d1d07.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:13.670750+00:00 · HTTP 200 · SHA-256 2987be11b0c14db4a77e5b6b1cf745361fe956c7fa6cb1f244e6e4dd104eb353.

  • 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 3307 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. ClinicalTrials.gov NCT03690206 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  2. ClinicalTrials.gov NCT05377333 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  3. ClinicalTrials.gov NCT06546384 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  4. ClinicalTrials.gov NCT06500143 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  5. ClinicalTrials.gov NCT01595789 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  6. ClinicalTrials.gov NCT04079855 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  7. ClinicalTrials.gov NCT07806838 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  8. ClinicalTrials.gov NCT01421147 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  9. ClinicalTrials.gov NCT01162876 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  10. ClinicalTrials.gov NCT01801540 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  11. ClinicalTrials.gov NCT02673138 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  12. ClinicalTrials.gov NCT03203915 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  13. ClinicalTrials.gov NCT06972238 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  14. ClinicalTrials.gov NCT01507285 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  15. ClinicalTrials.gov NCT00273000 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  16. ClinicalTrials.gov NCT02792400 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  17. ClinicalTrials.gov NCT00861809 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  18. ClinicalTrials.gov NCT02081001 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  19. ClinicalTrials.gov NCT05463744 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  20. ClinicalTrials.gov NCT07786675 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  21. ClinicalTrials.gov NCT07098663 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  22. ClinicalTrials.gov NCT04518930 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  23. ClinicalTrials.gov NCT03482830 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  24. ClinicalTrials.gov NCT02561130 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  25. ClinicalTrials.gov NCT01503112 — 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 Glucagon?

Manually reviewed September 15, 2026 · version 1

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

Three selected reports examine glucagon rescue formulations in diabetes. Nasal, intramuscular and ready-to-use subcutaneous products have different delivery contexts; related analogues and diagnostic uses require separate assessment.123

Bottom line from this bounded source set

Controlled studies found high recovery rates after experimentally induced hypoglycemia. A small uncontrolled study also reported recovery during spontaneous episodes. Laboratory recovery times and trained-caregiver observations do not establish equivalent performance in every emergency.123

Reviewed study record

Nasal versus intramuscular glucagon

Design

Randomized crossover noninferiority study after experimentally induced hypoglycemia.1

Population

66 adults with type 1 diabetes participated.1

Outcomes reported

Both formulations achieved treatment success in all participants within 25 minutes. Mean time to success was 11.4 minutes with nasal and 9.9 minutes with intramuscular glucagon.1

Limitations

The induced-hypoglycemia setting and controlled administration differ from an unplanned emergency. Recovery speed is distinct from preparation time and caregiver usability.1

Reviewed study record

Ready-to-use autoinjector versus emergency kit

Design

Two randomized crossover noninferiority studies after insulin-induced hypoglycemia.2

Population

161 adults with type 1 diabetes participated across the studies.2

Outcomes reported

The ready-to-use product met the prespecified noninferiority comparison. Mean time from administration to recovery was 13.8 versus 10.0 minutes; preparation and administration took 27.3 versus 97.2 seconds. Adverse-event profiles were reported as comparable.2

Limitations

Two studies share one publication. Administration-to-recovery and total preparation-plus-recovery intervals answer different questions; these results are not a product recommendation.2

Reviewed study record

Nasal glucagon during spontaneous episodes

Design

Prospective open-label real-world study with trained caregivers and no randomized comparator.3

Population

69 adults experienced 157 evaluable moderate or severe hypoglycemia episodes.3

Outcomes reported

Caregivers reported resolution within 30 minutes in 95.7% of patients. All 12 severe episodes resolved within 15 minutes.3

Limitations

Repeated episodes within people are not independent participants. Caregiver assessment, training and lack of a comparator limit causal and comparative conclusions.3

Reviewed source set

  1. PubMed · 32514794Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study. ↗PubMed PMID 32514794 · EFetch XML reviewed 2026-09-15 · payload SHA-256 186f030ee2c6f571989d2f1d7f6b548a3397d13a4a1fae43dcaa660f3514315c
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1007/s13300-020-00845-7. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  2. PubMed · 34620618Comparison of a ready-to-use liquid glucagon injection administered by autoinjector to glucagon emergency kit for the symptomatic relief of severe hypoglycemia: two randomized crossover non-inferiority studies. ↗PubMed PMID 34620618 · EFetch XML reviewed 2026-09-15 · payload SHA-256 e677d757f54ab8e574ededbffccbac54538058ba1be371bcffc8fba92de564a9
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1136/bmjdrc-2021-002137. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  3. PubMed · 29504662Prospective study evaluating the use of nasal glucagon for the treatment of moderate to severe hypoglycaemia in adults with type 1 diabetes in a real-world setting. ↗PubMed PMID 29504662 · EFetch XML reviewed 2026-09-15 · payload SHA-256 cdfec7c7ffcb3fe58014d74d781cc1ec070e5afa82732ebc049204945b455e92
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1111/dom.13278. 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 Glucagon?

U.S. label record. The cited label describes subcutaneous Gvoke for severe hypoglycemia in people with diabetes aged two years and older, and intravenous Gvoke VialDx as a diagnostic aid in adults. The product, route and indication must remain distinct.

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
4
Source years
23
Drugs@FDA applications
10

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?

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 Glucagon?

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.

308Selected dated records
309Connected citations
23Populated source years1960–2026
4/4Record lanes present

Registered human studies

Trial composition

4 of 31 selected trial records include at least one phase value; 4 of 31 include a status value in the retained structured contract.

153 public history versions connect to 29 of these trial records across 20 submitted years. Open the record-history collection →

PhasesPhase 1 3Not applicable 1
Status at observationActive, not recruiting 2Completed 1Recruiting 1

A phase value is unavailable here for 27 selected records; this is not counted as “no phase.”

A status value is unavailable here for 27 selected records; this is not counted as a trial status.

PubMed bibliography

Publication composition

129 of 248 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

Publication typesJournal Article 126Research Support, Non-U.S. Gov't 23English Abstract 22Review 15Comparative Study 12Case Reports 11Research Support, U.S. Gov't, Non-P.H.S. 5Letter 3Preprint 2Clinical Trial 1

Bibliography fields unavailable here for 119 selected records; the records remain visible as metadata observations.

Regulatory and publication surfaces

What is structurally connected?

Drugs@FDA applications
10
FDA Federal Register documents
16
DailyMed SPL versions
2
Canonical profile
Published
Profile structured data
Published
Linked dated records
308

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 Glucagon evidence record

Open all 308 records →
308Dated records
4Evidence types
308Cited public sources
23Source years

Change ledger

Recently changed for Glucagon

Open all 310 events →

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

Correction

Glucagon profile

The previous summary described this only as an emergency-treatment label. We now distinguish Gvoke's severe-hypoglycemia indication from Gvoke VialDx's diagnostic indication in the same cited label.

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

ClinicalTrials.gov record NCT03139305

PeptideScanner retained ClinicalTrials.gov record NCT03139305 at 2026-07-30T16:22:22.326Z. Its registry update date was 2026-03-30, and PeptideScanner's reviewed identity mapping was glucagon.

PeptideScanner change date
September 9, 2026
Cited source date
March 30, 2026
Evidence lane
Clinical trials
Record added

ClinicalTrials.gov record NCT06588504

PeptideScanner retained ClinicalTrials.gov record NCT06588504 at 2026-07-30T18:18:33.514Z. Its registry update date was 2025-12-05, and PeptideScanner's reviewed identity mapping was glucagon.

PeptideScanner change date
September 9, 2026
Cited source date
December 5, 2025
Evidence lane
Clinical trials

Official-source collections

Source records for Glucagon

Open the full research atlas →
PubMed248

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

  1. Role of glucagon in metabolic diseases.Journal of diabetes investigation · 2026 08 13
  2. Glutamine Metabolism Supports α cell Mass and Glucagon Secretion.bioRxiv : the preprint server for biology · 2026 07 13
  3. In vivo dysregulation of insulin and glucagon secretion: Disturbed mitochonderial VDAC1 expression and localization in pancreatic β-cells convey global insulin secretory defects in diabetic GK rat.Biochimica et biophysica acta. Molecular basis of disease · 2026 07 05
Explore all selected literature →
ClinicalTrials.gov31

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

  1. NCT05500586Registry update April 29, 2026 · completed at observation
  2. NCT06424106Registry update April 20, 2026 · current at observation
  3. NCT02817659Registry update March 30, 2026 · current at observation
Explore all selected trial records →Explore all public record history →
Drugs@FDA10

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

  1. ANDA218813Full FDA chronology · original submission status AP 2025-09-15
  2. ANDA214457Full FDA chronology · original submission status AP 2025-07-22
  3. ANDA204468Full FDA chronology · original submission status AP 2024-12-12
  4. ANDA208086Full FDA chronology · original submission status AP 2020-12-28
  5. NDA212097Full FDA chronology · original submission status AP 2019-09-10
Explore all selected FDA applications →Explore 92 dated submissions and 72 documents for Glucagon →
FDA enforcement reports1

Recall-enforcement metadata connected only through exact application numbers already mapped to this reviewed profile.

  1. D-0723-2026Class II · report date 2026-07-08
Explore all exact FDA enforcement reports →

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 November 14, 1960 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.

Leuprolide22 shared source years215 dated records · 4 evidence typesOctreotide19 shared source years160 dated records · 4 evidence typesTeriparatide17 shared source years149 dated records · 3 evidence typesExenatide16 shared source years119 dated records · 3 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 label describes subcutaneous Gvoke for severe hypoglycemia in people with diabetes aged two years and older, and intravenous Gvoke VialDx as a diagnostic aid in adults. The product, route and indication must remain distinct.

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

    Targeting glucagon signaling in metabolic disorders, functional insights from zebrafish receptor knockouts.

    PubMed lists PMID 42332291 in Cellular and molecular life sciences : CMLS as Journal Article, with publication-date metadata of 2026-06-22 (day precision). PeptideScanner associated the retained record with the identity slug glucagon. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

  2. Literature metadata

    Geographic Disparities in Glucagon Prescriptions Across North Carolina.

    PubMed lists PMID 40513916 in American journal of preventive medicine as Journal Article, with publication-date metadata of 2025-06-11 (day precision). PeptideScanner associated the retained record with the identity slug glucagon. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

  3. Literature metadata

    A new C-peptide minimal model to assess β-cell responsiveness to glucagon in individuals with and without type 2 diabetes.

    PubMed lists PMID 39925097 in American journal of physiology. Endocrinology and metabolism as Journal Article, with publication-date metadata of 2025-02-10 (day precision). PeptideScanner associated the retained record with the identity slug glucagon. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

  4. Literature metadata

    A Computational Glucoregulatory Model of Liver and Glucagon for the Evaluation of Therapeutics.

    PubMed lists PMID 40969902 in ACS pharmacology & translational science as Journal Article, with publication-date metadata of 2025-08-12 (day precision). PeptideScanner associated the retained record with the identity slug glucagon. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

  5. Literature metadata

    Glucagon secretion by pancreatic alpha-cells requires an intact tubulin-cytoskeleton-primary cilium axis.

    PubMed lists PMID 41667949 in Molecular medicine (Cambridge, Mass.) as Journal Article, with publication-date metadata of 2026-02-10 (day precision). PeptideScanner associated the retained record with the identity slug glucagon. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

  6. Literature metadata

    Glucose-dependent dynamics of glucagon, cortisol and adrenocorticotropic hormone before and after gastric bypass.

    PubMed lists PMID 41994483 in Journal of the Endocrine Society as Journal Article, with publication-date metadata of 2026-04-02 (day precision). PeptideScanner associated the retained record with the identity slug glucagon. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

  7. Literature metadata

    Engineering a Glucose-Responsive Glucagon Prodrug Through Arginine-Phenylboronic Acid Pendant Modification.

    PubMed lists PMID 41810046 in Small science as Journal Article, with publication-date metadata of 2026-03-06 (day precision). PeptideScanner associated the retained record with the identity slug glucagon. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

  8. Literature metadata

    Role of glucagon in metabolic diseases.

    PubMed lists PMID 42593182 in Journal of diabetes investigation as Journal Article, Review, with publication-date metadata of 2026-08-13 (day precision). PeptideScanner associated the retained record with the identity slug glucagon. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

  9. Literature metadata

    PubMed record PMID 42315494

    PeptideScanner retained PubMed bibliographic metadata for PMID 42315494 at 2026-08-10T10:49:10.699Z. PubMed recorded a metadata revision date of 2026-08-09 and an Entrez history date of 2026-06-18. PeptideScanner associated this retained record with the identity slug glucagon. These dates describe PubMed metadata history, not the article's original publication date.

  10. Literature metadata

    PubMed record PMID 38149727

    PeptideScanner retained PubMed bibliographic metadata for PMID 38149727 at 2026-08-10T10:49:06.860Z. PubMed recorded a metadata revision date of 2026-08-08 and an Entrez history date of 2023-12-27. PeptideScanner associated this retained record with the identity slug glucagon. These dates describe PubMed metadata history, not the article's original publication date.

  11. Literature metadata

    PubMed record PMID 38253809

    PeptideScanner retained PubMed bibliographic metadata for PMID 38253809 at 2026-08-10T10:49:06.874Z. PubMed recorded a metadata revision date of 2026-08-08 and an Entrez history date of 2024-01-22. PeptideScanner associated this retained record with the identity slug glucagon. These dates describe PubMed metadata history, not the article's original publication date.

  12. Literature metadata

    PubMed record PMID 42557738

    PeptideScanner retained PubMed bibliographic metadata for PMID 42557738 at 2026-08-10T10:49:13.006Z. PubMed recorded a metadata revision date of 2026-08-08 and an Entrez history date of 2026-08-06. PeptideScanner associated this retained record with the identity slug glucagon. These dates describe PubMed metadata history, not the article's original publication date.