U.S. label record. The cited DailyMed label identifies Pramlintide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.
Three selected reports examine pramlintide alongside insulin in diabetes. Two are year-long adjunctive-treatment trials; the third evaluates an experimental automated insulin-and-pramlintide system and is not interchangeable with routine labeled treatment.↗↗↗
What the reviewed sources report
Year-long trials reported modest HbA1c and weight changes compared with placebo added to insulin. Nausea was common. The automated-delivery study met its glucose-control noninferiority objective but did not improve its emotional-burden endpoint.↗↗↗
What remains unresolved?
What do the current label and complete trial reports establish about severe hypoglycemia and discontinuation?↗↗↗
Can longer studies reproduce the automated-delivery findings and assess patient-important outcomes?↗↗↗
The cited label describes adjunctive use with mealtime insulin in type 1 or type 2 diabetes when desired glucose control has not been achieved despite optimal insulin therapy. Pediatric safety and effectiveness have not been established. Label: 1, 8.4 ↗
Which safety limits matter?
The boxed warning concerns severe hypoglycemia when used with insulin, particularly in type 1 diabetes. Contraindications include hypoglycemia unawareness, confirmed gastroparesis and serious hypersensitivity. A study reporting no overall increase in severe events does not cancel the label warning. Label: 1, 4, 5, 8.4, boxed warning ↗
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.
Label ZIP SHA-256: 41e40e12d2e7bbf400a8bcd1a8032e423aa305f795982acb1264301692a93a15. Extracted XML SHA-256: e223f4cb25daee6d6785fc4e0d427c65dbbe94d27da19f34b5fafb7ba6a1842a.
Reviews summarize selected studies; their scope and limitations are shown above.
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.
Identity/name search without publication-type filtering; primary human reports, extensions, combinations and other reports require separate eligibility decisions. Known selected reports were recovered.
450 retrieved · 3 included · 0 excluded · 447 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"pramlintide"[Title/Abstract] OR "Symlin"[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 450 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 38906614 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT04163874.
PubMed 15498087 — include: Selected human report; abstract and record metadata reviewed. Study families: pramlintide-PMID15498087-registry-linkage-unresolved.
PubMed 12610038 — include: Selected human report; abstract and record metadata reviewed. Study families: pramlintide-PMID12610038-registry-linkage-unresolved.
PubMed 41207308 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42695140 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42452898 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41850952 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41702251 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 30000033 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41661442 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41747885 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41344603 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41167578 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41708975 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41549439 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40838347 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 25905364 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41022243 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41174925 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40618954 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40513482 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40360789 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40169506 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40332747 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 39998445 — 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.
1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
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 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
FDA NDA021332 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: PRAMLINTIDE ACETATE.
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.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov search
ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.
66 retrieved · 0 included · 0 excluded · 66 awaiting a decision · 0 full-text appraisals
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 66 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT00442767 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00673387 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03512236 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00690235 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01269008 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00950677 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00732147 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00819234 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT04972175 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05199714 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01708044 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06186063 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00229658 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00108004 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00291772 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02500979 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03547427 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01235741 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07679516 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03981627 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00206297 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT04163874 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT04074317 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00313183 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00042471 — 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 Pramlintide?
Three selected reports examine pramlintide alongside insulin in diabetes. Two are year-long adjunctive-treatment trials; the third evaluates an experimental automated insulin-and-pramlintide system and is not interchangeable with routine labeled treatment.123
Bottom line from this bounded source set
Year-long trials reported modest HbA1c and weight changes compared with placebo added to insulin. Nausea was common. The automated-delivery study met its glucose-control noninferiority objective but did not improve its emotional-burden endpoint.123
Reviewed study record
Type 1 diabetes: year-long adjunctive trial
Design
Randomized, double-blind, placebo-controlled trial over 52 weeks alongside insulin.1
The reported active groups had HbA1c reductions of 0.29–0.34 percentage points versus 0.04 with placebo. Weight declined by 0.4 kg versus a 0.8 kg increase. Transient nausea was the most common adverse event.1
Limitations
HbA1c and body weight are distinct from long-term complication outcomes. The abstract does not replace the full hypoglycemia analysis or label warnings.1
Reviewed study record
Type 2 diabetes: year-long adjunctive trial
Design
Randomized, double-blind, placebo-controlled trial over 52 weeks in insulin-treated patients.2
One active group had a 0.62 percentage-point HbA1c reduction at week 52 and weight change of −1.4 kg versus +0.7 kg with placebo. The authors reported no overall increase in severe-hypoglycemia rate; nausea was common.2
Limitations
A trial-wide hypoglycemia result does not negate regimen-specific risk or current boxed warnings. The report concerns selected insulin-treated patients.2
Reviewed study record
Experimental automated delivery
Design
Randomized crossover comparison of three automated-delivery approaches, each studied for 14 days.3
Population
32 participants enrolled; 30 completing all interventions were analyzed, including 15 adults and 15 adolescents.3
Outcomes reported
The insulin-and-pramlintide system with simple meal announcements met the prespecified glucose-control noninferiority comparison but did not improve emotional burden. Gastrointestinal symptoms occurred more often with pramlintide; no serious adverse events occurred.3
Limitations
The small, short crossover trial excluded noncompleters from the primary analysis. It evaluates a combined device-and-drug approach and cannot establish longer-term safety or a broader approved indication.3
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1111/j.1464-5491.2004.01319.x. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.2337/diacare.26.3.784. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/s2589-7500(24)00092-x. 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 Pramlintide?
U.S. label record. The cited DailyMed label identifies Pramlintide 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.
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.
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.
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
1
FDA Federal Register documents
2
DailyMed SPL versions
11
Canonical profile
Published
Profile structured data
Published
Linked dated records
67
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.
PeptideScanner retained ClinicalTrials.gov record NCT00206297 at 2026-07-30T21:36:16.909Z. Its registry update date was 2016-07-14, and PeptideScanner's reviewed identity mapping was pramlintide.
DailyMed lists Structured Product Labeling version 1 for the reviewed Pramlintide label family with a published date of 2015-01-08. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 11 for the reviewed Pramlintide label family with a published date of 2018-11-14. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
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.
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 Pramlintide 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.
PeptideScanner retained PubMed bibliographic metadata for PMID 41022243 at 2026-08-10T18:13:37.942Z. PubMed recorded a metadata revision date of 2026-07-11 and an Entrez history date of 2025-09-29. PeptideScanner associated this retained record with the identity slug pramlintide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41174925 at 2026-08-10T18:13:37.974Z. PubMed recorded a metadata revision date of 2026-07-05 and an Entrez history date of 2025-11-01. PeptideScanner associated this retained record with the identity slug pramlintide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 39109464 at 2026-07-30T16:14:08.819Z. PubMed recorded a metadata revision date of 2026-06-04 and an Entrez history date of 2024-08-07. PeptideScanner associated this retained record with the identity slug pramlintide. These dates describe PubMed metadata history, not the article's original publication date.↗
PubMed lists PMID 17064208 in Pharmacotherapy as Journal Article, Review, with publication-date metadata of 2006-11 (month precision). PeptideScanner associated the retained record with the identity slug pramlintide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 17624233 in Current medical research and opinion as Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, with publication-date metadata of 2007-08 (month precision). PeptideScanner associated the retained record with the identity slug pramlintide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 17909093 in Diabetes care as Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 2007-10-01 (day precision). PeptideScanner associated the retained record with the identity slug pramlintide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 19546056 in Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists as Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 2009 Nov-Dec (source-text precision). PeptideScanner associated the retained record with the identity slug pramlintide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 19858155 in Pediatrics as Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, with publication-date metadata of 2009-10-26 (day precision). PeptideScanner associated the retained record with the identity slug pramlintide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 19502544 in Diabetes care as Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, with publication-date metadata of 2009-06-05 (day precision). PeptideScanner associated the retained record with the identity slug pramlintide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 38906614 in The Lancet. Digital health as Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, with publication-date metadata of 2024-07 (month precision). PeptideScanner associated the retained record with the identity slug pramlintide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
DailyMed lists Structured Product Labeling version 18 for the reviewed Pramlintide label family with a published date of 2024-08-20. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.↗
DailyMed lists Structured Product Labeling version 17 for the reviewed Pramlintide label family with a published date of 2024-07-09. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.↗