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Linaclotide

FDA-approved product (capsule, oral), marketed as Linaclotide, Linzess.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
4 of 4

Chemical structure

Chemical structure of Linaclotide
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Constipation
  • Constipation disorder
  • Irritable bowel syndrome

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Other drugs for constipation
FDA pharmacologic class
Guanylate Cyclase-C Agonist FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis, MRSA, E. coli and K. pneumoniae. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA74.5% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli60.5% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae56.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis57.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

Not yet docked: queued in the docking rundetails

KPC-2 carbapenemase ↗ (K. pneumoniae)

Not yet docked: queued in the docking rundetails

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

Not yet docked: queued in the docking rundetails

Dihydrofolate reductase ↗ (MRSA)

Not yet docked: queued in the docking rundetails

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Linaclotide with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer

    NCT03796884 · start 2019-10-30

    Registered record
    Registry ID
    NCT03796884
    Conditions
    Colorectal Adenoma; Stage 0 Colorectal Cancer AJCC v8; Stage I Colorectal Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage IIA Colorectal Cancer AJCC v8; Stage IIB Colorectal Cancer AJCC v8; Stage IIC Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8
    Interventions
    Linaclotide; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2019-10-30
    Completion
    2026-09-30
    Enrolment
    150

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionColorectal Adenoma; Stage 0 Colorectal Cancer AJCC v8; Stage I Colorectal Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8 +7 more
    InterventionLinaclotide; Placebo
    PhasePhase 2
    Registry statusActive not recruiting
  • Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation

    NCT04110145 · start 2019-10-14

    Registered record
    Registry ID
    NCT04110145
    Conditions
    Functional Constipation
    Interventions
    Linaclotide; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2019-10-14
    Completion
    2021-04-20
    Enrolment
    35

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFunctional Constipation
    InterventionLinaclotide; Placebo
    PhasePhase 2
    Registry statusCompleted
  • Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)

    NCT04026113 · start 2019-10-01

    Registered record
    Registry ID
    NCT04026113
    Conditions
    Functional Constipation; Irritable Bowel Syndrome With Constipation
    Interventions
    Linaclotide; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2019-10-01
    Completion
    2024-05-29
    Enrolment
    438

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFunctional Constipation; Irritable Bowel Syndrome With Constipation
    InterventionLinaclotide; Placebo
    PhasePhase 3
    Registry statusCompleted
  • Assessment of Responsiveness to Treatment by Experience Sampling Method

    NCT03336034 · start 2018-01-01

    Registered record
    Registry ID
    NCT03336034
    Conditions
    Constipation-predominant Irritable Bowel Syndrome
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Terminated
    Start
    2018-01-01
    Completion
    2022-05-01
    Enrolment
    16

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionConstipation-predominant Irritable Bowel Syndrome
    InterventionNot recorded
    PhaseNot recorded
    Registry statusTerminated
  • Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)

    NCT03471728 · start 2017-10-02

    Registered record
    Registry ID
    NCT03471728
    Conditions
    Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases); Irritable Bowel Syndrome With Constipation (IBS-C)
    Interventions
    linaclotide
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2017-10-02
    Completion
    2021-12-31
    Enrolment
    2,475

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionChronic Constipation (CC) (Excluding Constipation Due to Organic Diseases); Irritable Bowel Syndrome With Constipation (IBS-C)
    Interventionlinaclotide
    PhaseNot recorded
    Registry statusCompleted
  • A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome

    NCT02970591 · start 2017-01

    Registered record
    Registry ID
    NCT02970591
    Conditions
    Irritable Bowel Syndrome
    Interventions
    Traditional dietary advice and low FODMAP content; Low carbohydrate diet; Optimized Medical treatment
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2017-01
    Completion
    2022-04-29
    Enrolment
    300

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionIrritable Bowel Syndrome
    InterventionTraditional dietary advice and low FODMAP content; Low carbohydrate diet; Optimized Medical treatment
    PhaseNot applicable
    Registry statusCompleted
  • A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)

    NCT02837783 · start 2016-12-21

    Registered record
    Registry ID
    NCT02837783
    Conditions
    Irritable Bowel Syndrome Characterized by Constipation
    Interventions
    Linaclotide; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Terminated
    Start
    2016-12-21
    Completion
    2018-10-31
    Enrolment
    20

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionIrritable Bowel Syndrome Characterized by Constipation
    InterventionLinaclotide; Placebo
    PhasePhase 4
    Registry statusTerminated
  • Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy

    NCT02781493 · start 2016-06

    Registered record
    Registry ID
    NCT02781493
    Conditions
    Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp
    Interventions
    2 mg Prucalopride plus 2 L Polyethylene Glycol regimen; 2 mg Placebo plus 2 L Polyethylene Glycol regimen
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2016-06
    Completion
    2017-03
    Enrolment
    600

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPrucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp
    Intervention2 mg Prucalopride plus 2 L Polyethylene Glycol regimen; 2 mg Placebo plus 2 L Polyethylene Glycol regimen
    PhasePhase 4
    Registry statusUnknown
  • Cognitive and Psychiatric Effects of Linaclotide on Patients With Constipation

    NCT03342287 · start 2016-03

    Registered record
    Registry ID
    NCT03342287
    Conditions
    Constipation; Irritable Bowel Syndrome
    Interventions
    questionnaires; cognitive evaluation; Blood; Fecal sample
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Withdrawn
    Start
    2016-03
    Completion
    2021-03
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionConstipation; Irritable Bowel Syndrome
    Interventionquestionnaires; cognitive evaluation; Blood; Fecal sample
    PhaseNot recorded
    Registry statusWithdrawn
  • A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)

    NCT02559570 · start 2015-11-03

    Registered record
    Registry ID
    NCT02559570
    Conditions
    Functional Constipation in Children Ages 6-17 Years
    Interventions
    Placebo; LIN Dose A; LIN Dose B; LIN Dose C; LIN 145 µg
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2015-11-03
    Completion
    2018-05-29
    Enrolment
    173

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFunctional Constipation in Children Ages 6-17 Years
    InterventionPlacebo; LIN Dose A; LIN Dose B; LIN Dose C +1 more
    PhasePhase 2
    Registry statusCompleted
  • A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation

    NCT02559817 · start 2015-11-01

    Registered record
    Registry ID
    NCT02559817
    Conditions
    Irritable Bowel Syndrome With Constipation
    Interventions
    Linaclotide Dose A; Linaclotide Dose B; Linaclotide Dose C; Linaclotide Approved Adult Dose; Matching Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2015-11-01
    Completion
    2019-08-30
    Enrolment
    101

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionIrritable Bowel Syndrome With Constipation
    InterventionLinaclotide Dose A; Linaclotide Dose B; Linaclotide Dose C; Linaclotide Approved Adult Dose +1 more
    PhasePhase 2
    Registry statusTerminated
  • An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation

    NCT02590432 · start 2015-11-01

    Registered record
    Registry ID
    NCT02590432
    Conditions
    Irritable Bowel Syndrome With Constipation; Chronic Idiopathic Constipation
    Interventions
    Linaclotide
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2015-11-01
    Completion
    2018-02-05
    Enrolment
    828

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionIrritable Bowel Syndrome With Constipation; Chronic Idiopathic Constipation
    InterventionLinaclotide
    PhasePhase 4
    Registry statusCompleted
  • Caecal pH as a Biomarker for Irritable Bowel Syndrome

    NCT02360384 · start 2015-11

    Registered record
    Registry ID
    NCT02360384
    Conditions
    Irritable Bowel Syndrome
    Interventions
    Linaclotide; FODMAP diet
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Unknown
    Start
    2015-11
    Completion
    2016-12
    Enrolment
    48

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionIrritable Bowel Syndrome
    InterventionLinaclotide; FODMAP diet
    PhaseNot applicable
    Registry statusUnknown
  • Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

    NCT02559206 · start 2015-10-22

    Registered record
    Registry ID
    NCT02559206
    Conditions
    Irritable Bowel Syndrome With Constipation
    Interventions
    Linaclotide; Matching Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2015-10-22
    Completion
    2016-09-30
    Enrolment
    759

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionIrritable Bowel Syndrome With Constipation
    InterventionLinaclotide; Matching Placebo
    PhasePhase 2
    Registry statusCompleted
  • Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation

    NCT03119584 · start 2015-09-01

    Registered record
    Registry ID
    NCT03119584
    Conditions
    Chronic Constipation; Diabete Mellitus
    Interventions
    linaclotide or placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Active not recruiting
    Start
    2015-09-01
    Completion
    2027-01
    Enrolment
    23

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionChronic Constipation; Diabete Mellitus
    Interventionlinaclotide or placebo
    PhasePhase 4
    Registry statusActive not recruiting