guanylate cyclase-C agonist

Plecanatide updates

Answer

2 changes for Plecanatide in the last 12 months. Latest: 2026-07-23.

DateTypeWhat changedSource
2026-07-23TrialNew trial registered: This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment GroTrial register ClinicalTrials.gov
2025-12-31ResultsResults posted: Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)Trial register ClinicalTrials.gov
2024-04-04LabelFDA label revised: Trulance Immediate release (NDA208745)Regulator FDA drug label register
2021-12-09TrialNew trial registered: Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional ConstipationTrial register ClinicalTrials.gov
2021-11-04TrialNew trial registered: GCC Agonist Signal in the Small IntestineTrial register ClinicalTrials.gov
2020-08-18ResultsResults posted: Long Term Safety Study of PlecanatideTrial register ClinicalTrials.gov
2020-01-02ResultsResults posted: SP-304 Dose Ranging Study in Patients With Chronic Idiopathic ConstipationTrial register ClinicalTrials.gov
2019-09-19ResultsResults posted: An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic ConstipationTrial register ClinicalTrials.gov
2019-09-17Federal RegisterFederal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityRegulator Federal Register
2019-07-02ResultsResults posted: Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)Trial register ClinicalTrials.gov
2019-06-14ResultsResults posted: The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)Trial register ClinicalTrials.gov
2019-06-14ResultsResults posted: Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)Trial register ClinicalTrials.gov
2019-03-21ResultsResults posted: 12-Week Study of Plecanatide for CIC (The CIC3 Study)Trial register ClinicalTrials.gov
2019-03-14ResultsResults posted: 12-Week Study of Plecanatide for CIC (The National CIC3 Study)Trial register ClinicalTrials.gov
2018-12-04Federal RegisterFederal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; TRULANCERegulator Federal Register
2018-11-29Federal RegisterFederal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityRegulator Federal Register
2018-09-17ResultsResults posted: The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)Trial register ClinicalTrials.gov
2018-07-24TrialNew trial registered: Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)Trial register ClinicalTrials.gov
2018-06-11TrialNew trial registered: A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®Trial register ClinicalTrials.gov
2017-11-29ResultsResults posted: The Plecanatide Chronic Idiopathic Constipation (CIC) StudyTrial register ClinicalTrials.gov
2017-04-19TrialNew trial registered: An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic ConstipationTrial register ClinicalTrials.gov
2016-03-11TrialNew trial registered: Long Term Safety Study of PlecanatideTrial register ClinicalTrials.gov
2015-07-09TrialNew trial registered: Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)Trial register ClinicalTrials.gov
2015-03-13TrialNew trial registered: The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)Trial register ClinicalTrials.gov
2014-04-24TrialNew trial registered: 12-Week Study of Plecanatide for CIC (The National CIC3 Study)Trial register ClinicalTrials.gov
2013-11-13TrialNew trial registered: 12-Week Study of Plecanatide for CIC (The CIC3 Study)Trial register ClinicalTrials.gov
2013-08-09TrialNew trial registered: Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)Trial register ClinicalTrials.gov
2012-11-06TrialNew trial registered: The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)Trial register ClinicalTrials.gov
2011-09-07TrialNew trial registered: The Plecanatide Chronic Idiopathic Constipation (CIC) StudyTrial register ClinicalTrials.gov
2010-01-12TrialNew trial registered: SP-304 Dose Ranging Study in Patients With Chronic Idiopathic ConstipationTrial register ClinicalTrials.gov

From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.

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