Research statistics

Linaclotide research: publications and trials

What has been published on Linaclotide: PubMed publications, the kind of evidence they report and registered clinical trials. These are counts of research, not a judgment of whether Linaclotide works or is safe. For what it is and what the studies found, see the Linaclotide profile.
Automated weekly refresh · data through November 1, 2026

At a glance

Publications, all years

347

Since 2007

Publications in 2026 so far

29

Through November 1, 2026

Human clinical research

30.6%

105 of 343 classified

Registered clinical trials

53

ClinicalTrials.gov

Randomized controlled trials

50

Publications reporting an RCT in people

Systematic reviews and meta-analyses

35

Preclinical studies

16.0%

29 animal · 17 in vitro · 9 computational

Records that only mention it

129

Not counted above

Status in the library: FDA-approved. 4 publications are not yet classified by study type.

What to keep in mind

  • Some completed trials have neither posted results nor a linked results publication.

Publications by year

Linaclotide publications by year and evidence

2007, Human clinical research: 1 of 22007, Reviews and meta-analyses: 1 of 22009, Human clinical research: 1 of 32009, Preclinical (animal, in vitro, computational): 1 of 32009, Reviews and meta-analyses: 1 of 32010, Human clinical research: 2 of 122010, Preclinical (animal, in vitro, computational): 3 of 122010, Reviews and meta-analyses: 4 of 122010, Other and not yet classified: 3 of 122011, Human clinical research: 1 of 82011, Reviews and meta-analyses: 7 of 82012, Human clinical research: 3 of 202012, Preclinical (animal, in vitro, computational): 2 of 202012, Reviews and meta-analyses: 9 of 202012, Other and not yet classified: 6 of 202013, Human clinical research: 4 of 402013, Reviews and meta-analyses: 23 of 402013, Other and not yet classified: 13 of 402014, Human clinical research: 4 of 212014, Preclinical (animal, in vitro, computational): 1 of 212014, Reviews and meta-analyses: 13 of 212014, Other and not yet classified: 3 of 212015, Human clinical research: 2 of 162015, Preclinical (animal, in vitro, computational): 3 of 162015, Reviews and meta-analyses: 8 of 162015, Other and not yet classified: 3 of 162016, Human clinical research: 1 of 122016, Preclinical (animal, in vitro, computational): 3 of 122016, Reviews and meta-analyses: 6 of 122016, Other and not yet classified: 2 of 122017, Human clinical research: 4 of 152017, Preclinical (animal, in vitro, computational): 4 of 152017, Reviews and meta-analyses: 6 of 152017, Other and not yet classified: 1 of 152018, Human clinical research: 11 of 272018, Preclinical (animal, in vitro, computational): 6 of 272018, Reviews and meta-analyses: 6 of 272018, Other and not yet classified: 4 of 272019, Human clinical research: 5 of 112019, Preclinical (animal, in vitro, computational): 1 of 112019, Reviews and meta-analyses: 5 of 112020, Human clinical research: 5 of 142020, Preclinical (animal, in vitro, computational): 5 of 142020, Reviews and meta-analyses: 4 of 142021, Human clinical research: 9 of 252021, Preclinical (animal, in vitro, computational): 8 of 252021, Reviews and meta-analyses: 8 of 252022, Human clinical research: 7 of 112022, Reviews and meta-analyses: 2 of 112022, Other and not yet classified: 2 of 112023, Human clinical research: 3 of 122023, Preclinical (animal, in vitro, computational): 4 of 122023, Other and not yet classified: 5 of 122024, Human clinical research: 14 of 292024, Preclinical (animal, in vitro, computational): 4 of 292024, Reviews and meta-analyses: 5 of 292024, Other and not yet classified: 6 of 292025, Human clinical research: 17 of 402025, Preclinical (animal, in vitro, computational): 7 of 402025, Reviews and meta-analyses: 13 of 402025, Other and not yet classified: 3 of 402026 (to date), Human clinical research: 11 of 292026 (to date), Preclinical (animal, in vitro, computational): 3 of 292026 (to date), Reviews and meta-analyses: 12 of 292026 (to date), Other and not yet classified: 3 of 29Human clinical researchPreclinical (animal, in vitro, computational)Reviews and meta-analysesOther and not yet classified01020304020072012201620202026*
Counted PubMed publications by year of first publication. * 2026 runs to November 1, 2026. A larger bar is more publications, not stronger evidence.
Show the data
YearHuman clinical researchPreclinical (animal, in vitro, computational)Reviews and meta-analysesOther and not yet classifiedTotal
200710102
200911103
2010234312
201110708
2012329620
201340231340
20144113321
2015238316
2016136212
2017446115
20181166427
2019515011
2020554014
2021988025
2022702211
2023340512
20241445629
202517713340
2026 (to date)11312329

Study types

Review98
Randomized controlled trial50
Editorial, letter or other42
Observational human study39
Animal study29
Meta-analysis22
In vitro study17
Systematic review13
Other clinical trial11
Computational study9
Case report5
Guideline or consensus5
Not yet classified4
Correction or retraction notice3

Research areas

From MeSH major topics. A paper can be in several areas.

Gastrointestinal300
Neurological and mental health18
Oncology11
Reproductive and sexual health7
Antimicrobial and infectious disease4
Cardiovascular3
Obesity and weight management3
Dermatology2
Immune system2
Metabolic health2
Cognitive health1
Endocrinology1

Registered clinical trials

10 of 35 trials completed at least a year before the cutoff have neither posted results nor a linked results publication. A registration is not a result.

Completed: 38 · Unknown status: 5 · Recruiting: 3 · Terminated: 3 · Active, not recruiting: 2 · Not yet recruiting: 2
Early phase 1: 1 · Phase not applicable: 10 · Phase 1: 5 · Phase 1 / Phase 2: 1 · Phase 2: 13 · Phase 3: 15 · Phase 4: 8

TrialStatusPhaseStartedResults
MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO)NCT07780344 · 12 enrolledNot yet recruitingPhase not applicable2026-09—
Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic FibrosisNCT07569419 · 26 enrolledRecruitingEarly phase 12026-03—
"Efficacy and Safety of Linaclotide in Chronic Constipation"NCT07431957 · 90 enrolledNot yet recruitingPhase 42026-02—
Linaclotide for Colonoscopy Bowel PrepNCT06692673 · 10 enrolledRecruitingPhase 1, Phase 22025-12—
Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for ColonoscopyNCT06748638 · 444 enrolledUnknown statusPhase 42024-09—
A Study of Virtual Reality and Linaclotide for IBS-CNCT05796388 · 65 enrolledRecruitingPhase not applicable2024-05—
Clinical Study of Bowel Preparation Before ColonoscopyNCT06091735 · 444 enrolledCompletedPhase not applicable2023-08—
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 LinaclotideNCT05760313 · 19 enrolledCompletedPhase 22023-04Posted
A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional ConstipationNCT05652205 · 123 enrolledCompletedPhase 32022-12Posted
GCC Agonist Signal in the Small IntestineNCT05107219 · 43 enrolledCompletedPhase 12022-11—
Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel PreparationNCT05379491 · 720 enrolledCompletedPhase not applicable2022-08—
Application of Linaclotide Capsule in Bowel Preparation for ColonoscopyNCT05291325 · 1,607 enrolledCompletedPhase not applicable2022-05—
Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic ConstipationNCT05137145 · 300 enrolledUnknown statusPhase not applicable2021-09—
Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic ConstipationNCT04804267 · 750 enrolledUnknown statusPhase 32021-03—
Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal DisordersNCT05134584 · 78 enrolledUnknown statusPhase 42021-01—
Linaclotide in Treating Patients With Stages 0-3 Colorectal CancerNCT03796884 · 150 enrolledActive, not recruitingPhase 22019-10—
Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional ConstipationNCT04110145 · 35 enrolledCompletedPhase 22019-10Posted
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 · 438 enrolledCompletedPhase 32019-10Posted
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)NCT03573908 · 614 enrolledCompletedPhase 32018-06Posted
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)NCT03471728 · 2,475 enrolledCompletedPhase not applicable2017-10—
A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)NCT02837783 · 20 enrolledTerminatedPhase 42016-12Posted
A Study of Oral Dosing of ASP0456 in Patients With Chronic ConstipationNCT02809105 · 186 enrolledCompletedPhase 32016-06—
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 · 173 enrolledCompletedPhase 22015-11Posted
Caecal pH as a Biomarker for Irritable Bowel SyndromeNCT02360384 · 48 enrolledUnknown statusPhase not applicable2015-11—
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With ConstipationNCT02559817 · 101 enrolledTerminatedPhase 22015-11Posted
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 ConstipationNCT02590432 · 828 enrolledCompletedPhase 42015-11Posted
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)NCT02559206 · 759 enrolledCompletedPhase 22015-10Posted
Efficacy of Linaclotide in Type II Diabetics With Chronic ConstipationNCT03119584 · 23 enrolledActive, not recruitingPhase 42015-09—
A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic ConstipationNCT02425722 · 383 enrolledCompletedPhase 22015-04—
Single-dose Linaclotide for Capsule Endoscopy PreparationNCT02465385 · 30 enrolledCompletedPhase 42015-02—
Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer PainNCT02270983 · 254 enrolledCompletedPhase 22014-10Posted
Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel SyndromeNCT02316899 · 500 enrolledCompletedPhase 32014-10—
Trial of Linaclotide in Patients With Chronic Idiopathic ConstipationNCT02291679 · 1,223 enrolledCompletedPhase 32014-10Posted
Efficacy of Linaclotide to Senna for CICNCT02239510 · 9 enrolledTerminatedPhase not applicable2014-09Posted
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide TherapeuticallyNCT02220348 · 7 enrolledCompletedPhase 12014-07—
Effect to Linaclotide on Colonic MotilityNCT06989268 · 10 enrolledCompletedPhase 42014-02—
Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C PatientsNCT02078323 · 39 enrolledCompletedPhase not applicable2014-02—
Linaclotide Acetate in Preventing Colorectal Cancer in Healthy VolunteersNCT01950403 · 24 enrolledCompletedPhase 12013-09—
A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)NCT01880424 · 1,722 enrolledCompletedPhase 32013-07Posted
A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel SyndromeNCT01714843 · 559 enrolledCompletedPhase 22012-08—
Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal BloatingNCT01642914 · 487 enrolledCompletedPhase 32012-08Posted
A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy SubjectsNCT01427387 · 44 enrolledCompletedPhase 12011-06—
A Safety and Pharmacokinetics Study of ASP0456 in Healthy SubjectsNCT01279915 · 32 enrolledCompletedPhase 12010-10—
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)NCT00938717 · 805 enrolledCompletedPhase 32009-07Posted
Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With ConstipationNCT00948818 · 803 enrolledCompletedPhase 32009-07Posted
An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With ConstipationNCT00765999 · 1,559 enrolledCompletedPhase 32008-10Posted
An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With ConstipationNCT00730171 · 1,743 enrolledCompletedPhase 32008-09Posted
Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic ConstipationNCT00765882 · 633 enrolledCompletedPhase 32008-09Posted
Trial of Linaclotide in Patients With Chronic ConstipationNCT00730015 · 643 enrolledCompletedPhase 32008-08Posted
Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)NCT00460811 · 420 enrolledCompletedPhase 22007-04Posted

The 50 most recently started of 53 trials.

Human trials and evidence reviews

Meta-analyses, systematic reviews and trials in people, newest first.

  1. Adjunctive linaclotide improves bowel cleansing and patient experience in polyethylene glycol-based bowel preparation.

    Scientific reports · April 20, 2026 · Meta-analysis · cited 0 times · open access

    PMID 42009975 · DOI 10.1038/s41598-026-49852-x · Reviews and meta-analyses

  2. Safety and efficacy of linaclotide as an adjuvant for bowel preparation: A systematic review and meta-analysis.

    Arab journal of gastroenterology : the official publication of the Pan-Arab Association of Gastroenterology · November 6, 2025 · Meta-analysis · cited 0 times

    PMID 41203453 · DOI 10.1016/j.ajg.2025.09.017 · Reviews and meta-analyses

  3. Exploring the Efficacy and Safety of Linaclotide in Pediatric Patients of Functional Constipation and IBS-C: A Meta-Analysis of Randomized Control Trials.

    Gastroenterology & hepatology · November 1, 2025 · Meta-analysis · cited 0 times

    PMID 41625189 · Reviews and meta-analyses

  4. Linaclotide combined with polyethylene glycol for bowel preparation in colonoscopy: a systematic review and meta-analysis of randomized controlled trials.

    Surgical endoscopy · October 30, 2025 · Meta-analysis · cited 3 times

    PMID 41168471 · DOI 10.1007/s00464-025-12288-x · Reviews and meta-analyses

  5. The Efficacy of Single Dose Linaclotide in Polyethylene Glycol-Based Bowel Preparation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Journal of clinical gastroenterology · October 23, 2025 · Meta-analysis · cited 2 times

    PMID 41123247 · DOI 10.1097/mcg.0000000000002267 · Reviews and meta-analyses

  6. Efficacy and safety of pharmacological therapies for functional constipation in children: a systematic review and meta-analysis.

    The Lancet. Child & adolescent health · October 13, 2025 · Meta-analysis · cited 6 times · open access

    PMID 41101321 · DOI 10.1016/s2352-4642(25)00219-6 · Reviews and meta-analyses

  7. Efficacy and safety of polyethylene glycol in combination with linaclotide versus polyethylene glycol alone for colonoscopy: a grade-assessed systematic review and meta-analysis.

    Clinical endoscopy · September 1, 2025 · Meta-analysis · cited 2 times · open access

    PMID 40899243 · DOI 10.5946/ce.2025.073 · Reviews and meta-analyses

  8. Efficacy and Safety of Linaclotide as an Adjunct to Polyethylene Glycol in Bowel Preparation: A Meta-Analysis.

    Journal of digestive diseases · July 1, 2025 · Meta-analysis · cited 3 times · open access

    PMID 40955723 · DOI 10.1111/1751-2980.70008 · Reviews and meta-analyses

  9. The Safety of Pharmacotherapy for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis.

    The American journal of gastroenterology · June 5, 2025 · Meta-analysis · cited 8 times · open access

    PMID 40471839 · DOI 10.14309/ajg.0000000000003572 · Reviews and meta-analyses

  10. Comparative profiles of lubiprostone, linaclotide, and elobixibat for chronic constipation: a systematic literature review with meta-analysis and number needed to treat/harm.

    BMC gastroenterology · January 2, 2024 · Meta-analysis · cited 28 times · open access

    PMID 38166671 · DOI 10.1186/s12876-023-03104-8 · Reviews and meta-analyses

Most cited

By OpenAlex citation count. Citations measure attention, not quality or correctness.

  1. Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety.

    The American journal of gastroenterology · November 1, 2012 · Randomized controlled trial · cited 464 times

    PMID 22986437 · DOI 10.1038/ajg.2012.254 · Human clinical research

  2. A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation.

    The American journal of gastroenterology · November 1, 2012 · Randomized controlled trial · cited 384 times · open access

    PMID 22986440 · DOI 10.1038/ajg.2012.255 · Human clinical research

  3. Effect of laxatives and pharmacological therapies in chronic idiopathic constipation: systematic review and meta-analysis.

    Gut · February 1, 2011 · Meta-analysis · cited 383 times · open access

    PMID 21205879 · DOI 10.1136/gut.2010.227132 · Reviews and meta-analyses

  4. Two randomized trials of linaclotide for chronic constipation.

    The New England journal of medicine · August 1, 2011 · Randomized controlled trial · cited 376 times · open access

    PMID 21830967 · DOI 10.1056/nejmoa1010863 · Human clinical research

  5. Linaclotide inhibits colonic nociceptors and relieves abdominal pain via guanylate cyclase-C and extracellular cyclic guanosine 3',5'-monophosphate.

    Gastroenterology · August 16, 2013 · Randomized controlled trial · cited 297 times · open access

    PMID 23958540 · DOI 10.1053/j.gastro.2013.08.017 · Human clinical research

Latest publications

  1. Development and internal validation of a prediction model for suboptimal bowel preparation in individuals aged ≤50 years undergoing colonoscopy.

    Frontiers in medicine · September 23, 2026 · Observational human study · cited 0 times · open access

    PMID 42846315 · DOI 10.3389/fmed.2026.1939670 · Human clinical research

  2. Pharmacotherapy of Irritable Bowel Syndrome with Constipation in Children: An Update on Clinical Progress and Successes.

    Drugs · September 23, 2026 · Review · cited 0 times

    PMID 42773320 · DOI 10.1007/s40265-026-02376-0 · Reviews and meta-analyses

  3. Efficacy and Safety of Linaclotide in Pediatric Patients of Functional Constipation: A Meta-analysis of Randomized Controlled Trials.

    The Annals of pharmacotherapy · September 4, 2026 · Review · cited 0 times

    PMID 42695347 · DOI 10.1177/10600280261479335 · Reviews and meta-analyses

  4. Effect of Age and Age-Defined Menopausal Status on Linaclotide Efficacy and Safety in Adults With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation: Post Hoc Analyses of Phase 2b/3 Studies.

    Neurogastroenterology and motility · September 1, 2026 · Other clinical trial · cited 0 times · open access

    PMID 42702764 · DOI 10.1111/nmo.70429 · Human clinical research

  5. Patients' Real-World Experiences With Pharmacologic Therapies for Irritable Bowel Syndrome With Constipation: A Mixed-Methods Analysis and Classification of Social Media and E-Forum Posts.

    Neurogastroenterology and motility · September 1, 2026 · Observational human study · cited 0 times · open access

    PMID 42694017 · DOI 10.1111/nmo.70432 · Human clinical research

  6. Efficacy of linaclotide as adjunct for bowel preparation in patients with chronic constipation: a pre-specified analysis of the APPLE trial.

    Clinical endoscopy · August 20, 2026 · Observational human study · cited 0 times · open access

    PMID 42681900 · DOI 10.5946/ce.2026.214 · Human clinical research

  7. Resolving conformational polymorphism in disulfide-rich peptide drugs.

    Frontiers in chemistry · August 17, 2026 · In vitro study · cited 0 times · open access

    PMID 42676398 · DOI 10.3389/fchem.2026.1913741 · In vitro studies

  8. Secretagogue laxatives as a potential strategy to overcome adherence barriers to over-the-counter treatment for clozapine-induced constipation.

    The mental health clinician · August 3, 2026 · Case report · cited 0 times · open access

    PMID 42569232 · DOI 10.9740/mhc.2026.08.207 · Human clinical research

  9. Rapid and comprehensive identification of the metabolic soft spots of peptide drugs with highly cross-linked disulfide bonds by integrating established proteomic workflow with a product ion filtering strategy.

    Drug metabolism and disposition: the biological fate of chemicals · July 17, 2026 · In vitro study · cited 0 times

    PMID 42612545 · DOI 10.1016/j.dmd.2026.100371 · In vitro studies

  10. Efficacy safety of linaclotide combined with polyethylene glycol for bowel preparation in patients with constipation: a meta-analysis.

    Frontiers in gastroenterology (Lausanne, Switzerland) · July 14, 2026 · Systematic review · cited 0 times · open access

    PMID 42523615 · DOI 10.3389/fgstr.2026.1694950 · Reviews and meta-analyses

Browse all 347 publications in the dashboard

How this is counted

PubMed records matched by the names below, counted when the peptide is in the title, indexed by MeSH, or confirmed from the abstract. The exact query can be rerun on Europe PMC. Methodology

Search terms: Constella; Linaclotida; Linaclotide; Linzess; MD-1100

((TITLE_ABS:"Constella" OR CHEM:"Constella") OR (TITLE_ABS:"Linaclotida" OR CHEM:"Linaclotida") OR (TITLE_ABS:"Linaclotide" OR CHEM:"Linaclotide") OR (TITLE_ABS:"Linzess" OR CHEM:"Linzess") OR (TITLE_ABS:"MD-1100" OR CHEM:"MD-1100" OR TITLE_ABS:"MD1100" OR CHEM:"MD1100")) AND SRC:MED

Cite this page

Peptide Library. (2026, November 2). Linaclotide research statistics (Version weekly-2026-11-01) [Statistic]. Peptide Library. https://peptidelibrary.app/research/peptides/linaclotide