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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 MRSA, E. coli, K. pneumoniae and M. tuberculosis. 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.

  • Single-dose Linaclotide for Capsule Endoscopy Preparation

    NCT02465385 · start 2015-02

    Registered record
    Registry ID
    NCT02465385
    Conditions
    Crohn's; Ulcerative Colitis; Gastrointestinal Bleeding
    Interventions
    Linaclotide
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2015-02
    Completion
    2016-06
    Enrolment
    30

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

    ConditionCrohn's; Ulcerative Colitis; Gastrointestinal Bleeding
    InterventionLinaclotide
    PhasePhase 4
    Registry statusCompleted
  • Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

    NCT02316899 · start 2014-10-21

    Registered record
    Registry ID
    NCT02316899
    Conditions
    Irritable Bowel Syndrome With Constipation (IBS-C)
    Interventions
    linaclotide; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2014-10-21
    Completion
    2016-03-29
    Enrolment
    500

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

    ConditionIrritable Bowel Syndrome With Constipation (IBS-C)
    Interventionlinaclotide; Placebo
    PhasePhase 3
    Registry statusCompleted
  • Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

    NCT02291679 · start 2014-10

    Registered record
    Registry ID
    NCT02291679
    Conditions
    Chronic Idiopathic Constipation
    Interventions
    Linaclotide; Matching Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2014-10
    Completion
    2015-08
    Enrolment
    1,223

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

    ConditionChronic Idiopathic Constipation
    InterventionLinaclotide; Matching Placebo
    PhasePhase 3
    Registry statusCompleted
  • A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically

    NCT02220348 · start 2014-07-31

    Registered record
    Registry ID
    NCT02220348
    Conditions
    Breast Feeding; Constipation; Irritable Bowel Syndrome
    Interventions
    linaclotide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-07-31
    Completion
    2019-05-31
    Enrolment
    7

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

    ConditionBreast Feeding; Constipation; Irritable Bowel Syndrome
    Interventionlinaclotide
    PhasePhase 1
    Registry statusCompleted
  • Effect to Linaclotide on Colonic Motility

    NCT06989268 · start 2014-02-10

    Registered record
    Registry ID
    NCT06989268
    Conditions
    Chronic Constipation
    Interventions
    Linaclotide 290 micrograms; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2014-02-10
    Completion
    2015-06-03
    Enrolment
    10

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

    ConditionChronic Constipation
    InterventionLinaclotide 290 micrograms; Placebo
    PhasePhase 4
    Registry statusCompleted
  • Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients

    NCT02078323 · start 2014-02

    Registered record
    Registry ID
    NCT02078323
    Conditions
    Irritable Bowel Syndrome With Constipation (IBS-C)
    Interventions
    Linaclotide; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2014-02
    Completion
    2018-07-20
    Enrolment
    39

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

    ConditionIrritable Bowel Syndrome With Constipation (IBS-C)
    InterventionLinaclotide; Placebo
    PhaseNot applicable
    Registry statusCompleted
  • Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers

    NCT01950403 · start 2013-09

    Registered record
    Registry ID
    NCT01950403
    Conditions
    Colorectal Cancer; Healthy, no Evidence of Disease
    Interventions
    linaclotide acetate; placebo; pharmacological study; laboratory biomarker analysis
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-09
    Completion
    2018-02-22
    Enrolment
    24

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

    ConditionColorectal Cancer; Healthy, no Evidence of Disease
    Interventionlinaclotide acetate; placebo; pharmacological study; laboratory biomarker analysis
    PhasePhase 1
    Registry statusCompleted
  • A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

    NCT01714843 · start 2012-08-10

    Registered record
    Registry ID
    NCT01714843
    Conditions
    Constipation-predominant Irritable Bowel Syndrome (IBS-C)
    Interventions
    linaclotide; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2012-08-10
    Completion
    2013-12-07
    Enrolment
    559

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

    ConditionConstipation-predominant Irritable Bowel Syndrome (IBS-C)
    Interventionlinaclotide; placebo
    PhasePhase 2
    Registry statusCompleted
  • Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

    NCT01642914 · start 2012-08

    Registered record
    Registry ID
    NCT01642914
    Conditions
    Chronic Constipation; Constipation
    Interventions
    Linaclotide 290 micrograms; Linaclotide 145 micrograms; Matching placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-08
    Completion
    2013-08
    Enrolment
    487

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

    ConditionChronic Constipation; Constipation
    InterventionLinaclotide 290 micrograms; Linaclotide 145 micrograms; Matching placebo
    PhasePhase 3
    Registry statusCompleted
  • A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects

    NCT01279915 · start 2010-10

    Registered record
    Registry ID
    NCT01279915
    Conditions
    Healthy; Pharmacokinetics of ASP0456
    Interventions
    ASP0456; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2010-10
    Completion
    2011-01
    Enrolment
    32

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

    ConditionHealthy; Pharmacokinetics of ASP0456
    InterventionASP0456; Placebo
    PhasePhase 1
    Registry statusCompleted
  • Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

    NCT00938717 · start 2009-07

    Registered record
    Registry ID
    NCT00938717
    Conditions
    Irritable Bowel Syndrome With Constipation
    Interventions
    Linaclotide or Matching Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2009-07
    Completion
    2010-09
    Enrolment
    805

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

    ConditionIrritable Bowel Syndrome With Constipation
    InterventionLinaclotide or Matching Placebo
    PhasePhase 3
    Registry statusCompleted
  • Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

    NCT00948818 · start 2009-07

    Registered record
    Registry ID
    NCT00948818
    Conditions
    Irritable Bowel Syndrome Characterized by Constipation
    Interventions
    Linaclotide 290 micrograms; Matching placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2009-07
    Completion
    2010-08
    Enrolment
    803

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

    ConditionIrritable Bowel Syndrome Characterized by Constipation
    InterventionLinaclotide 290 micrograms; Matching placebo
    PhasePhase 3
    Registry statusCompleted
  • An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

    NCT00765999 · start 2008-10-31

    Registered record
    Registry ID
    NCT00765999
    Conditions
    Chronic Constipation; Irritable Bowel Syndrome With Constipation
    Interventions
    Linaclotide
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2008-10-31
    Completion
    2012-01-31
    Enrolment
    1,559

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

    ConditionChronic Constipation; Irritable Bowel Syndrome With Constipation
    InterventionLinaclotide
    PhasePhase 3
    Registry statusCompleted
  • An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

    NCT00730171 · start 2008-09

    Registered record
    Registry ID
    NCT00730171
    Conditions
    Irritable Bowel Syndrome With Constipation; Chronic Constipation
    Interventions
    Linaclotide
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2008-09
    Completion
    2012-03
    Enrolment
    1,743

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

    ConditionIrritable Bowel Syndrome With Constipation; Chronic Constipation
    InterventionLinaclotide
    PhasePhase 3
    Registry statusCompleted
  • Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

    NCT00765882 · start 2008-09

    Registered record
    Registry ID
    NCT00765882
    Conditions
    Chronic Constipation
    Interventions
    Linaclotide 290 micrograms; Linaclotide 145 micrograms; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2008-09
    Completion
    2009-08
    Enrolment
    633

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

    ConditionChronic Constipation
    InterventionLinaclotide 290 micrograms; Linaclotide 145 micrograms; Placebo
    PhasePhase 3
    Registry statusCompleted