PeptideScanner
U.S. label record↗Gastrointestinal↗

Linaclotide↗

Related names in cited records: Linzess↗

A guanylate cyclase-C agonist peptide. 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 Linaclotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗

Status sources checked through July 22, 2026. See status sources and coverage →

What do the reviewed human studies say?

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

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

Two publications report adult chronic-constipation trials and a pediatric functional-constipation trial. They do not cover the full irritable-bowel-syndrome program or every currently labeled age group.↗↗

What the reviewed sources report

Randomized trials reported improved bowel-movement measures over 12 weeks. Diarrhea is an important adverse effect; the pediatric trial included a serious dehydration event related to severe diarrhea.↗↗

What remains unresolved?

  • What additional trials address irritable bowel syndrome and other age groups?↗↗
  • How do current regulatory labels and longer follow-up refine the safety assessment?↗↗

Read study designs, results, limitations, and sources →

What does the U.S. product label say?

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

Which population and use does the label cover?

The June 2026 label distinguishes IBS with constipation in adults and children aged seven years and older, chronic idiopathic constipation in adults, and functional constipation in children aged two years and older. Label: 1 ↗

Which safety limits matter?

The boxed warning concerns serious dehydration in children younger than two, for whom the product is contraindicated. The label also lists known or suspected mechanical gastrointestinal obstruction as a contraindication and describes potentially severe diarrhea. Label: 1, 4, 5, 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.

LINZESS (linaclotide) capsule · SPL version 39 · published 2026-06-01

Label ZIP SHA-256: 77c54fc2bf053002e1fd77970d745d4088919827b5a4a74d5d139cf8df320a54. Extracted XML SHA-256: 0e36407b126e3d4b3c616c030ed28362be4484ad305e337e12c319145523082a.

Open versioned label context data →

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

European medicine records · 1 products or applications

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

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

Open versioned records and source-feed pins →

Research coverage and study families

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

Open machine-readable coverage and record decisions →

PubMed search

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

477 retrieved · 2 included · 0 excluded · 475 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"linaclotide"[Title/Abstract] OR "Linzess"[Title/Abstract] OR "Constella"[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 477 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 38211604 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT04026113.
  2. PubMed 21830967 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT00730015; NCT00765882.
  3. PubMed 42319080 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  4. PubMed 42695347 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  5. PubMed 42702764 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  6. PubMed 42694017 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  7. PubMed 42283961 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  8. PubMed 42242129 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  9. PubMed 42681900 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  10. PubMed 42676398 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  11. PubMed 42569232 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  12. PubMed 42425925 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  13. PubMed 42612545 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  14. PubMed 42523615 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  15. PubMed 42482900 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  16. PubMed 42465095 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  17. PubMed 41913506 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  18. PubMed 39950440 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  19. PubMed 42278633 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  20. PubMed 41692643 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  21. PubMed 41987372 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  22. PubMed 42083746 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  23. PubMed 42066057 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  24. PubMed 41413756 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
  25. PubMed 41123247 — 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.

4 retrieved · 4 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

products.active_ingredients.name:"LINACLOTIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:19.050259+00:00 · HTTP 200 · SHA-256 4ca45091d9b10f758b1c006b68001601f064b335e2dcdf2b90a511e46a7eb8a7.

  • 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 4 of 4 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. FDA NDA202811 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LINACLOTIDE.
  2. FDA ANDA209564 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LINACLOTIDE.
  3. FDA ANDA211255 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LINACLOTIDE.
  4. FDA ANDA209611 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LINACLOTIDE.

EMA search

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

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

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Linaclotide", "Linzess"]

Source retrievals and payload pins
  • Open the source endpoint ↗

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

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

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

  1. EMA EMEA/H/C/002490 — include: EMA feed product Constella; 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.

22 retrieved · 16 included · 0 excluded · 6 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Linaclotide", "Linzess"]

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 22 of 22 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA 9966 — include: Document linked by EMA product number; content unappraised. Constella-H-C-2490-PSUV-09 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  2. EMA 28212 — include: Document linked by EMA product number; content unappraised. Constella-H-C-PSUSA-00010025-201508 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  3. EMA 30350 — include: Document linked by EMA product number; content unappraised. Constella : EPAR - All Authorised presentations
  4. EMA 35371 — include: Document linked by EMA product number; content unappraised. Constella : EPAR - Summary for the public
  5. EMA 40909 — include: Document linked by EMA product number; content unappraised. Constella : EPAR - Public assessment report
  6. EMA 45239 — include: Document linked by EMA product number; content unappraised. Constella-H-C-2490-P46-013 : EPAR - Assessment report
  7. EMA 47891 — include: Document linked by EMA product number; content unappraised. Constella-H-C-PSUSA-00010025-201908 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  8. EMA 55862 — include: Document linked by EMA product number; content unappraised. Constella-H-C-2490-P46-017 : EPAR - Assessment report
  9. EMA 58685 — include: Document linked by EMA product number; content unappraised. Constella-H-C-2490-P46-019 : EPAR - Assessment report
  10. EMA 58766 — include: Document linked by EMA product number; content unappraised. Constella-H-C-2490-P46-018 : EPAR - Assessment report
  11. EMA 63724 — include: Document linked by EMA product number; content unappraised. Constella : EPAR - Risk management plan
  12. EMA 69064 — include: Document linked by EMA product number; content unappraised. Constella-H-C-002490-P46-020 : EPAR - Assessment report
  13. EMA 33744 — include: Document linked by EMA product number; content unappraised. Constella : EPAR - Procedural steps taken and scientific information after authorisation (archive)
  14. EMA 72289 — include: Document linked by EMA product number; content unappraised. Constella : EPAR - Procedural steps taken and scientific information after authorisation
  15. EMA 74280 — include: Document linked by EMA product number; content unappraised. Constella-PSUSA-00010025-202508 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  16. EMA 13191 — include: Document linked by EMA product number; content unappraised. Constella : EPAR - Product Information
  17. EMA 60891 — not screened: Title-name match awaiting identity and document review. P/0529/2022: EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for linaclotide (Constella), (EMEA-000927-PIP01-10-M07)
  18. EMA 50429 — not screened: Title-name match awaiting identity and document review. P/0216/2021 : EMA decision of 8 June 2021 on the acceptance of a modification of an agreed paediatric investigation plan for linaclotide (Constella) (EMEA-000927-PIP01-10-M06)
  19. EMA 5926 — not screened: Title-name match awaiting identity and document review. P/0252/2016: EMA decision of 26 September 2016 on the acceptance of a modification of an agreed paediatric investigation plan for linaclotide (Constella), (EMEA-000927-PIP01-10-M03)
  20. EMA 32832 — not screened: Title-name match awaiting identity and document review. P/110/2011: EMA decision of 6 May 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for linaclotide (EMEA-000927-PIP01-10)
  21. EMA 37470 — not screened: Title-name match awaiting identity and document review. P/0106/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for linaclotide (Constella), (EMEA-000927-PIP01-10-M01)
  22. EMA 68951 — not screened: Title-name match awaiting identity and document review. P/0207/2024: EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for linaclotide (Constella) (EMEA-000927-PIP01-10-M08)

EMA search

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

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

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Linaclotide", "Linzess"]

Source retrievals and payload pins
  • Open the source endpoint ↗

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

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

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

    ClinicalTrials.gov search

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

    63 retrieved · 0 included · 0 excluded · 63 awaiting a decision · 0 full-text appraisals

    Search terms, record decisions and remaining work

    "Linaclotide" OR "Linzess" OR "Constella"

    Source retrievals and payload pins
    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:26:27.505907+00:00 · HTTP 200 · SHA-256 23b2996ef03aae49ccc09c32aa0fc9fc4520332ae325d405cce0544e739d2fce.

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

    1. ClinicalTrials.gov NCT01427387 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    2. ClinicalTrials.gov NCT03336034 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    3. ClinicalTrials.gov NCT00306748 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    4. ClinicalTrials.gov NCT02270983 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    5. ClinicalTrials.gov NCT00460811 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    6. ClinicalTrials.gov NCT00948818 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    7. ClinicalTrials.gov NCT03224494 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    8. ClinicalTrials.gov NCT00765882 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    9. ClinicalTrials.gov NCT07569419 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    10. ClinicalTrials.gov NCT00339690 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    11. ClinicalTrials.gov NCT02465385 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    12. ClinicalTrials.gov NCT00730171 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    13. ClinicalTrials.gov NCT06692673 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    14. ClinicalTrials.gov NCT00402337 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    15. ClinicalTrials.gov NCT05796388 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    16. ClinicalTrials.gov NCT02837783 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    17. ClinicalTrials.gov NCT01880424 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    18. ClinicalTrials.gov NCT02590432 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    19. ClinicalTrials.gov NCT02291679 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    20. ClinicalTrials.gov NCT06989268 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    21. ClinicalTrials.gov NCT04532879 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    22. ClinicalTrials.gov NCT04110145 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    23. ClinicalTrials.gov NCT02809105 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    24. ClinicalTrials.gov NCT02316899 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    25. ClinicalTrials.gov NCT03796884 — 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 Linaclotide?

    Manually reviewed September 15, 2026 · version 1

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

    Two publications report adult chronic-constipation trials and a pediatric functional-constipation trial. They do not cover the full irritable-bowel-syndrome program or every currently labeled age group.12

    Bottom line from this bounded source set

    Randomized trials reported improved bowel-movement measures over 12 weeks. Diarrhea is an important adverse effect; the pediatric trial included a serious dehydration event related to severe diarrhea.12

    Reviewed study record

    Adult chronic constipation: two trials

    Design

    Two randomized, double-blind, placebo-controlled 12-week trials tested two active groups.1

    Population

    1,276 adults with chronic constipation participated across the trials.1

    Outcomes reported

    The prespecified bowel-response endpoint was reached by approximately 16–21% of active-group participants versus 3–6% with placebo. Diarrhea led to discontinuation in 4.2% of active-group participants.1

    Limitations

    One publication contains two trials. Short follow-up cannot establish long-term benefit or uncommon harms, and the results do not automatically extend to other diagnoses or ages.1

    Reviewed study record

    Pediatric functional constipation

    Design

    Randomized, double-blind, placebo-controlled phase 3 trial lasting 12 weeks.2

    Population

    330 children aged 6–17 years were randomized; 328 received treatment and 293 completed.2

    Outcomes reported

    The adjusted between-group difference was 1.17 additional spontaneous bowel movements per week. Diarrhea occurred in seven of 164 active-group and three of 164 placebo participants; one active-group participant required hospitalization for dehydration.2

    Limitations

    The trial addresses functional constipation in the enrolled age range. Its findings cannot establish safety in younger children or replace age-specific label warnings.2

    Reviewed source set

    1. PubMed · 21830967Two randomized trials of linaclotide for chronic constipation. ↗PubMed PMID 21830967 · EFetch XML reviewed 2026-09-15 · payload SHA-256 24d773849646882ab3031eef6fc3481ce604a26f409a13a58e22a2004aca0a3b
      No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1056/nejmoa1010863. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
    2. PubMed · 38211604Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. ↗PubMed PMID 38211604 · EFetch XML reviewed 2026-09-15 · payload SHA-256 58b2d55045c664eb19aec9f97374ea3268f561017615f37584eb189d4c41c982
      No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/s2468-1253(23)00398-9. 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 Linaclotide?

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

    100Dated records49PubMed records15Trial records35Regulatory records

    Evidence present

    What records are connected here?

    Evidence lanes
    4
    Source years
    15
    Drugs@FDA applications
    3

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

    Latest source-dated record

    What changed most recently at a cited source?

    Literature metadata · source date August 3, 2026

    PubMed record PMID 41692643↗Added to PeptideScanner August 10, 2026

    Coverage gaps

    What remains unknown or unsupported?

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

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

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

    Evidence Map v1

    What kinds of records connect to Linaclotide?

    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.

    100Selected dated records
    101Connected citations
    15Populated source years2012–2026
    4/4Record lanes present
    Clinical trials15Open matching records →Literature metadata49Open matching records →Regulatory35Open matching records →Safety1Open matching records →

    Registered human studies

    Trial composition

    5 of 15 selected trial records include at least one phase value; 5 of 15 include a status value in the retained structured contract.

    218 public history versions connect to 13 of these trial records across 19 submitted years. Open the record-history collection →

    PhasesPhase 2 2Phase 3 2Not applicable 1
    Status at observationCompleted 3Active, not recruiting 1Recruiting 1

    A phase value is unavailable here for 10 selected records; this is not counted as “no phase.”

    A status value is unavailable here for 10 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 21Comment 5Research Support, Non-U.S. Gov't 4Letter 3Review 3Randomized Controlled Trial 2Clinical Trial 1Clinical Trial, Phase II 1Clinical Trial, Phase III 1Editorial 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
    3
    FDA Federal Register documents
    4
    DailyMed SPL versions
    28
    Canonical profile
    Published
    Profile structured data
    Published
    Linked dated records
    100

    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 Linaclotide evidence record

    Open all 100 records →
    100Dated records
    4Evidence types
    100Cited public sources
    15Source years

    Change ledger

    Recently changed for Linaclotide

    Open all 101 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 NCT03573908

    PeptideScanner retained ClinicalTrials.gov record NCT03573908 at 2026-07-30T20:18:37.978Z. Its registry update date was 2020-12-01, and PeptideScanner's reviewed identity mapping was linaclotide.

    PeptideScanner change date
    September 9, 2026
    Cited source date
    December 1, 2020
    Evidence lane
    Clinical trials
    Open the cited record →
    Cited source
    Record added

    ClinicalTrials.gov record NCT05760313

    PeptideScanner retained ClinicalTrials.gov record NCT05760313 at 2026-07-30T16:25:18.002Z. Its registry update date was 2026-01-06, and PeptideScanner's reviewed identity mapping was linaclotide.

    PeptideScanner change date
    September 9, 2026
    Cited source date
    January 6, 2026
    Evidence lane
    Clinical trials
    Open the cited record →
    Cited source
    Record added

    Editorial: repurposed linaclotide and the quest for abdominal pain management in irritable bowel syndrome.

    PubMed lists PMID 36565004 in Alimentary pharmacology & therapeutics as Editorial, Comment, with publication-date metadata of 2023-01 (month precision). PeptideScanner associated the retained record with the identity slug linaclotide. 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
    February 26, 2023
    Evidence lane
    Literature metadata
    Open the cited record →
    Cited source

    Official-source collections

    Source records for Linaclotide

    Open the full research atlas →
    PubMed49

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

    Journal Article (21)Comment (5)Research Support, Non-U.S. Gov't (4)
    1. Linaclotide Use for the Treatment of Constipation and Gastrointestinal Symptoms in People With Cystic Fibrosis.Pediatric pulmonology · 2024 12 02
    2. Linaclotide as a Single Agent Bowel Preparation Regimen Before Colonoscopy.The American surgeon · 2024 11 12
    3. Characterization of disulfide bridges containing cyclic peptide Linaclotide and its degradation products by using LC-HRMS/MS.Journal of pharmaceutical and biomedical analysis · 2024 10 17
    Explore all selected literature →
    ClinicalTrials.gov15

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

    Recruiting history (123)Active Not Recruiting history (54)Completed history (23)
    Current at observation (3)Completed at observation (12)
    Chronic Idiopathic Constipation (CIC) (1)Colorectal Adenoma (1)Functional Constipation (1)Phase 2 (2)Phase 3 (2)Completed (3)Active, not recruiting (1)
    Linaclotide · Drug (4)Linzess · Drug (3)Linaclotide · Device (1)
    1. NCT05796388Registry update July 29, 2026 · current at observation
    2. NCT03796884Registry update July 22, 2026 · current at observation
    3. NCT05652205Registry update May 14, 2026 · completed at observation
    Explore all selected trial records →Explore all public record history →
    FDA enforcement reports1

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

    1. D-0417-2021Class II · report date 2021-06-02
    Explore all exact FDA enforcement reports →
    DailyMed SPL history28

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

    1. SPL version 39Published 2026-06-01 · ZIP SHA-256 77c54fc2bf05…
    2. SPL version 38Published 2026-01-16 · ZIP SHA-256 d34462beabf1…
    3. SPL version 36Published 2025-11-17 · ZIP SHA-256 65eb80d6a219…
    4. SPL version 34Published 2024-07-11 · ZIP SHA-256 c7453e08068f…
    5. SPL version 33Published 2023-09-21 · ZIP SHA-256 43fb2fc11c3a…
    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 August 30, 2012 to August 3, 2026.

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    Profiles with overlapping source-year coverage

    Open the research atlas →

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

    Leuprolide15 shared source years215 dated records · 4 evidence typesLiraglutide15 shared source years167 dated records · 4 evidence typesOctreotide15 shared source years160 dated records · 4 evidence typesTeriparatide15 shared source years149 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 DailyMed label identifies Linaclotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗

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

    Cited context

    Related records

    Organizations named in cited records

    • U.S. National Library of Medicine↗

    Dated source history

    Updates connected to this profile

    Open the full cross-source timeline →

    1. Literature metadata

      PubMed record PMID 41692643↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 41692643 at 2026-08-10T10:49:08.765Z. PubMed recorded a metadata revision date of 2026-08-03 and an Entrez history date of 2026-02-15. PeptideScanner associated this retained record with the identity slug linaclotide. These dates describe PubMed metadata history, not the article's original publication date.↗

    2. Literature metadata

      PubMed record PMID 42425925↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 42425925 at 2026-08-10T10:49:10.758Z. PubMed recorded a metadata revision date of 2026-08-03 and an Entrez history date of 2026-07-09. PeptideScanner associated this retained record with the identity slug linaclotide. These dates describe PubMed metadata history, not the article's original publication date.↗

    3. Clinical trials

      ClinicalTrials.gov record NCT05796388↗

      PeptideScanner retained ClinicalTrials.gov record NCT05796388 at 2026-08-10T18:10:03.859Z. Its registry update date was 2026-07-29, and PeptideScanner's reviewed identity mapping was linaclotide.↗

    4. Literature metadata

      PubMed record PMID 42523615↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 42523615 at 2026-08-10T18:13:56.783Z. PubMed recorded a metadata revision date of 2026-07-29 and an Entrez history date of 2026-07-29. PeptideScanner associated this retained record with the identity slug linaclotide. These dates describe PubMed metadata history, not the article's original publication date.↗

    5. Literature metadata

      PubMed record PMID 41913506↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 41913506 at 2026-08-10T18:13:46.784Z. PubMed recorded a metadata revision date of 2026-07-28 and an Entrez history date of 2026-03-31. PeptideScanner associated this retained record with the identity slug linaclotide. These dates describe PubMed metadata history, not the article's original publication date.↗

    6. Literature metadata

      PubMed record PMID 42009975↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 42009975 at 2026-08-10T18:13:48.763Z. PubMed recorded a metadata revision date of 2026-07-26 and an Entrez history date of 2026-04-20. PeptideScanner associated this retained record with the identity slug linaclotide. These dates describe PubMed metadata history, not the article's original publication date.↗

    7. Literature metadata

      PubMed record PMID 38962910↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 38962910 at 2026-08-10T18:13:32.376Z. PubMed recorded a metadata revision date of 2026-07-23 and an Entrez history date of 2024-07-04. PeptideScanner associated this retained record with the identity slug linaclotide. These dates describe PubMed metadata history, not the article's original publication date.↗

    8. Clinical trials

      ClinicalTrials.gov record NCT03796884↗

      PeptideScanner retained ClinicalTrials.gov record NCT03796884 at 2026-08-10T18:10:04.224Z. Its registry update date was 2026-07-22, and PeptideScanner's reviewed identity mapping was linaclotide.↗

    9. Literature metadata

      PubMed record PMID 42482900↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 42482900 at 2026-08-10T18:13:56.703Z. PubMed recorded a metadata revision date of 2026-07-22 and an Entrez history date of 2026-07-22. PeptideScanner associated this retained record with the identity slug linaclotide. These dates describe PubMed metadata history, not the article's original publication date.↗

    10. Literature metadata

      PubMed record PMID 42465095↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 42465095 at 2026-08-10T18:13:55.292Z. PubMed recorded a metadata revision date of 2026-07-17 and an Entrez history date of 2026-07-17. PeptideScanner associated this retained record with the identity slug linaclotide. These dates describe PubMed metadata history, not the article's original publication date.↗

    11. Literature metadata

      PubMed record PMID 42083746↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 42083746 at 2026-08-10T18:13:48.845Z. PubMed recorded a metadata revision date of 2026-07-16 and an Entrez history date of 2026-05-05. PeptideScanner associated this retained record with the identity slug linaclotide. These dates describe PubMed metadata history, not the article's original publication date.↗

    12. Literature metadata

      PubMed record PMID 39370607↗

      PeptideScanner retained PubMed bibliographic metadata for PMID 39370607 at 2026-07-30T16:11:44.834Z. PubMed recorded a metadata revision date of 2026-07-01 and an Entrez history date of 2024-10-07. PeptideScanner associated this retained record with the identity slug linaclotide. These dates describe PubMed metadata history, not the article's original publication date.↗

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