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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 K. pneumoniae, MRSA, E. coli 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.

  • MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO)

    NCT07780344 · start 2026-09

    Registered record
    Registry ID
    NCT07780344
    Conditions
    Cystic Fibrosis (CF)
    Interventions
    Linaclotide 290 micrograms; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Not yet recruiting
    Start
    2026-09
    Completion
    2027-08
    Enrolment
    12

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

    ConditionCystic Fibrosis (CF)
    InterventionLinaclotide 290 micrograms; Placebo
    PhaseNot applicable
    Registry statusNot yet recruiting
  • Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis

    NCT07569419 · start 2026-03-09

    Registered record
    Registry ID
    NCT07569419
    Conditions
    Cystic Fibrosis (CF)
    Interventions
    Linaclotide 290 micrograms; Lactose placebo pill
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Recruiting
    Start
    2026-03-09
    Completion
    2026-10
    Enrolment
    26

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

    ConditionCystic Fibrosis (CF)
    InterventionLinaclotide 290 micrograms; Lactose placebo pill
    PhaseEarly phase 1
    Registry statusRecruiting
  • "Efficacy and Safety of Linaclotide in Chronic Constipation"

    NCT07431957 · start 2026-02-20

    Registered record
    Registry ID
    NCT07431957
    Conditions
    Chronic Idiopathic Constipation; Irritable Bowel Syndrome (IBS-C); Chronic Constipation; CIC; Constipation Predominant Irritable Bowel Syndrome
    Interventions
    Linaclotide 72 micrograms; Linaclotide 145 micrograms; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Not yet recruiting
    Start
    2026-02-20
    Completion
    2027-01-31
    Enrolment
    90

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

    ConditionChronic Idiopathic Constipation; Irritable Bowel Syndrome (IBS-C); Chronic Constipation; CIC +1 more
    InterventionLinaclotide 72 micrograms; Linaclotide 145 micrograms; Placebo
    PhasePhase 4
    Registry statusNot yet recruiting
  • Linaclotide for Colonoscopy Bowel Prep

    NCT06692673 · start 2025-12-01

    Registered record
    Registry ID
    NCT06692673
    Conditions
    Patients Scheduled for Colonoscopy
    Interventions
    Use of Linaclotide as a single agent Colonoscopy prep
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2025-12-01
    Completion
    2026-07-28
    Enrolment
    10

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

    ConditionPatients Scheduled for Colonoscopy
    InterventionUse of Linaclotide as a single agent Colonoscopy prep
    PhasePhase 1 / Phase 2
    Registry statusRecruiting
  • A Study of Virtual Reality and Linaclotide for IBS-C

    NCT05796388 · start 2024-05-31

    Registered record
    Registry ID
    NCT05796388
    Conditions
    Irritable Bowel Syndrome With Constipation
    Interventions
    Virtual Reality
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Recruiting
    Start
    2024-05-31
    Completion
    2026-10
    Enrolment
    65

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

    ConditionIrritable Bowel Syndrome With Constipation
    InterventionVirtual Reality
    PhaseNot applicable
    Registry statusRecruiting
  • Clinical Study of Bowel Preparation Before Colonoscopy

    NCT06091735 · start 2023-08-01

    Registered record
    Registry ID
    NCT06091735
    Conditions
    Bowel Preparation
    Interventions
    OSS; OSS+Linzess; PEG-Interferon Alfa
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2023-08-01
    Completion
    2024-02-25
    Enrolment
    444

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

    ConditionBowel Preparation
    InterventionOSS; OSS+Linzess; PEG-Interferon Alfa
    PhaseNot applicable
    Registry statusCompleted
  • A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide

    NCT05760313 · start 2023-04-27

    Registered record
    Registry ID
    NCT05760313
    Conditions
    Functional Constipation
    Interventions
    Linaclotide; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2023-04-27
    Completion
    2025-06-09
    Enrolment
    19

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

    ConditionFunctional Constipation
    InterventionLinaclotide; Placebo
    PhasePhase 2
    Registry statusCompleted
  • GCC Agonist Signal in the Small Intestine

    NCT05107219 · start 2022-11-30

    Registered record
    Registry ID
    NCT05107219
    Conditions
    Barrett Esophagus; Gastroesophageal Reflux Disease; Malignant Digestive System Neoplasm
    Interventions
    Biopsy; Biospecimen Collection; Esophagogastroduodenoscopy; Linaclotide; Plecanatide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2022-11-30
    Completion
    2026-02-06
    Enrolment
    43

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

    ConditionBarrett Esophagus; Gastroesophageal Reflux Disease; Malignant Digestive System Neoplasm
    InterventionBiopsy; Biospecimen Collection; Esophagogastroduodenoscopy; Linaclotide +1 more
    PhasePhase 1
    Registry statusCompleted
  • Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel Preparation

    NCT05379491 · start 2022-08-01

    Registered record
    Registry ID
    NCT05379491
    Conditions
    Colonoscopy
    Interventions
    3 L PEG + linaclotide; 3 L PEG + placebo
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2022-08-01
    Completion
    2023-07-15
    Enrolment
    720

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

    ConditionColonoscopy
    Intervention3 L PEG + linaclotide; 3 L PEG + placebo
    PhaseNot applicable
    Registry statusCompleted
  • Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy

    NCT05291325 · start 2022-05-25

    Registered record
    Registry ID
    NCT05291325
    Conditions
    Bowel Preparation for Colonoscopy
    Interventions
    3L PEG + Linaclotide; 3L PEG; 2L PEG + Linaclotide
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2022-05-25
    Completion
    2024-04-28
    Enrolment
    1,607

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

    ConditionBowel Preparation for Colonoscopy
    Intervention3L PEG + Linaclotide; 3L PEG; 2L PEG + Linaclotide
    PhaseNot applicable
    Registry statusCompleted
  • Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation

    NCT05137145 · start 2021-09-01

    Registered record
    Registry ID
    NCT05137145
    Conditions
    Bowel Preparation
    Interventions
    Linaclotide; Compound Polyethylene Glycol Electrolyte Powder
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Unknown
    Start
    2021-09-01
    Completion
    2022-04-30
    Enrolment
    300

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

    ConditionBowel Preparation
    InterventionLinaclotide; Compound Polyethylene Glycol Electrolyte Powder
    PhaseNot applicable
    Registry statusUnknown
  • HygiRelief Procedure and HygiSample Evaluation for Functional Constipation

    NCT04532879 · start 2021-09

    Registered record
    Registry ID
    NCT04532879
    Conditions
    Rome IV Functional Constipation
    Interventions
    HygiPrep (HyGIeaCare System)
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Withdrawn
    Start
    2021-09
    Completion
    2022-06
    Enrolment
    0

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

    ConditionRome IV Functional Constipation
    InterventionHygiPrep (HyGIeaCare System)
    PhaseNot applicable
    Registry statusWithdrawn
  • Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

    NCT05134584 · start 2021-01-01

    Registered record
    Registry ID
    NCT05134584
    Conditions
    Functional Dyspepsia; Constipation-predominant Irritable Bowel Syndrome
    Interventions
    Linaclotide; Lactulose; Omeprazol; Itopride
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2021-01-01
    Completion
    2022-02
    Enrolment
    78

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

    ConditionFunctional Dyspepsia; Constipation-predominant Irritable Bowel Syndrome
    InterventionLinaclotide; Lactulose; Omeprazol; Itopride
    PhasePhase 4
    Registry statusUnknown
  • Evaluate the Safety of Linaclotide in IBS-C Patients in China

    NCT04462900 · start 2020-09-18

    Registered record
    Registry ID
    NCT04462900
    Conditions
    Irritable Bowel Syndrome-IBS
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2020-09-18
    Completion
    2023-02-03
    Enrolment
    3,028

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

    ConditionIrritable Bowel Syndrome-IBS
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted
  • Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C

    NCT04166058 · start 2019-11-19

    Registered record
    Registry ID
    NCT04166058
    Conditions
    Irritable Bowel Syndrome With Constipation; Functional Constipation
    Interventions
    Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers); Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2019-11-19
    Completion
    2025-06-05
    Enrolment
    381

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

    ConditionIrritable Bowel Syndrome With Constipation; Functional Constipation
    InterventionIrritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers); Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
    PhasePhase 3
    Registry statusCompleted