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Evidence dashboardStudies since 2006Updated Jul 31, 2026

LinaclotideClinical Trials.

A source-linked view of every Linaclotide study in the current snapshot—status, phase, enrollment, results, publications, locations and changes over time.

Total trials
59
Recruiting
3
Completed
41
Terminated
4
Results posted
24
Average enrollment
394
Countries
23
Highest phase
Phase 4

Developer / research origin

Ironwood Pharmaceuticals

Evidence summary

Activity is not efficacy.

Linaclotide appears in 59 indexed studies: 3 recruiting, 41 completed and 24 with registry results posted. The highest registered development stage in this snapshot is Phase 4. These counts measure registry activity; they do not establish that Linaclotide is safe or effective.

Review the design, endpoints, population, protocol changes, statistical analysis and publications before drawing conclusions.

Development history

Trial timeline.

Evidence timeline

20062026

Velocity

Linaclotide studies by start year

Study start year · indexed snapshot

8642020062006: 3 trials2007: 1 trials2008: 4 trials2009: 2 trials20102010: 1 trials2011: 1 trials2012: 2 trials2013: 2 trials20142014: 7 trials2015: 8 trials2016: 4 trials2017: 2 trials20182018: 2 trials2019: 4 trials2020: 1 trials2021: 4 trials20222022: 4 trials2023: 2 trials2024: 2 trials2025: 1 trials20262026: 2 trials

Development

Trials by phase

Early Phase 11
Phase 16
Phase 214
Phase 316
Phase 49

Current studies

Recruiting or active

Completed studies

Finished records

Stopped studies

Withdrawn or terminated

Showing 6 of 7 studies
Showing 6 of 41 studies

Full study index

Search Linaclotide trials.

Add status, phase, condition, country, result and publication filters inside this molecule’s indexed study set.

59 matching studies

Latest publications

Follow the paper trail.

PMID 34511390Stefano MA, Sandy NS, Zagoya C, Duckstein F, Ribeiro AF, Mainz JG, Lomazi EA. Diagnosing constipation in patients with cystic fibrosis applying ESPGHAN criteria. J Cyst Fibros. 2022 May;21(3):497-501. doi: 10.1016/j.jcf.2021.08.021. Epub 2021 Sep 9. No abstract available.Linked from NCT07569419PMID 32389617Stefano MA, Poderoso RE, Mainz JG, Ribeiro JD, Ribeiro AF, Lomazi EA. Prevalence of constipation in cystic fibrosis patients: a systematic review of observational studies. J Pediatr (Rio J). 2020 Nov-Dec;96(6):686-692. doi: 10.1016/j.jped.2020.03.004. Epub 2020 May 8.Linked from NCT07569419PMID 3748682Rubinstein S, Moss R, Lewiston N. Constipation and meconium ileus equivalent in patients with cystic fibrosis. Pediatrics. 1986 Sep;78(3):473-9.Linked from NCT07569419PMID 30118317McHugh DR, Cotton CU, Moss FJ, Vitko M, Valerio DM, Kelley TJ, Hao S, Jafri A, Drumm ML, Boron WF, Stern RC, McBennett K, Hodges CA. Linaclotide improves gastrointestinal transit in cystic fibrosis mice by inhibiting sodium/hydrogen exchanger 3. Am J Physiol Gastrointest Liver Physiol. 2018 Nov 1;315(5):G868-G878. doi: 10.1152/ajpgi.00261.2017. Epub 2018 Aug 17.Linked from NCT07569419PMID 20626735Marciani L, Wright J, Foley S, Hoad CL, Totman JJ, Bush D, Hartley C, Armstrong A, Manby P, Blackshaw E, Perkins AC, Gowland PA, Spiller RC. Effects of a 5-HT(3) antagonist, ondansetron, on fasting and postprandial small bowel water content assessed by magnetic resonance imaging. Aliment Pharmacol Ther. 2010 Sep;32(5):655-63. doi: 10.1111/j.1365-2036.2010.04395.x.Linked from NCT07569419PMID 25060551Marciani L, Garsed KC, Hoad CL, Fields A, Fordham I, Pritchard SE, Placidi E, Murray K, Chaddock G, Costigan C, Lam C, Jalanka-Tuovinen J, De Vos WM, Gowland PA, Spiller RC. Stimulation of colonic motility by oral PEG electrolyte bowel preparation assessed by MRI: comparison of split vs single dose. Neurogastroenterol Motil. 2014 Oct;26(10):1426-36. doi: 10.1111/nmo.12403. Epub 2014 Jul 24.Linked from NCT07569419PMID 38533975Luo M, Liu Y, Nikolovska K, Riederer B, Patrucco E, Hofmann F, Seidler U. cGMP-dependent kinase 2, Na+/H+ exchanger NHE3, and PDZ-adaptor NHERF2 co-assemble in apical membrane microdomains. Acta Physiol (Oxf). 2024 Apr;240(4):e14125. doi: 10.1111/apha.14125. Epub 2024 Mar 27.Linked from NCT07569419PMID 31428412Hayee B, Watson KL, Campbell S, Simpson A, Farrell E, Hutchings P, Macedo P, Perrin F, Whelan K, Elston C. A high prevalence of chronic gastrointestinal symptoms in adults with cystic fibrosis is detected using tools already validated in other GI disorders. United European Gastroenterol J. 2019 Aug;7(7):881-888. doi: 10.1177/2050640619841545.Linked from NCT07569419

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