Drug

Plecanatide

Approved medicine

ClassHeat-stable enterotoxin receptor agonistResearchOngoing clinical research

Also known as Trulance.

RxNorm1873752 ChEMBLCHEMBL2103867 ATCA06AX07UNII7IK8Z952OK

Guanylyl cyclase C

Primary target

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Pilot Study of GCC Agonists to Identify a Cyclic-GMP Signal in Duodenal Tissue of Volunteers

Clinical trial2026-02-06Completed · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)

Clinical trial2025-12-31Results posted · ClinicalTrials.gov

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Plecanatide in the Treatment of Functional Constipation in Chinese Patients for up to 12 Weeks

Clinical trial2023-10-26Completed · ClinicalTrials.gov

An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Clinical trial2020-08-18Results posted · ClinicalTrials.gov

A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation (The CIC3 Study)

Clinical trial2019-12-26Results posted · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-controlled, 3 Dose Level, Parallel Group Study of the Efficacy and Safety of Plecanatide in Adolescents 12 to < 18 Years of Age With Chronic Idiopathic Constipation (CIC)

Clinical trial2019-10-04Results posted · ClinicalTrials.gov

An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)

Clinical trial2019-07-02Results posted · ClinicalTrials.gov

A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Clinical trial2019-06-14Results posted · ClinicalTrials.gov

Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Clinical trial2019-06-14Results posted · ClinicalTrials.gov

A National, Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation

Clinical trial2019-05-28Results posted · ClinicalTrials.gov

A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Clinical trial2019-05-28Results posted · ClinicalTrials.gov

Study SP304-20210: A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Chronic Idiopathic Constipation

Clinical trial2019-05-28Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Plecanatide

Aliases & brands

Trulance

RxNorm CUI

1873752

ChEMBL ID

CHEMBL2103867

ATC codes

A06AX07

UNII

7IK8Z952OK

Primary mechanism

Heat-stable enterotoxin receptor agonist

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Guanylyl cyclase C

GUCY2C · P25092

AGONISTHeat-stable enterotoxin receptor agonist

Clinical trials

12 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Late-stage (III+)

Completed

PHASE DISTRIBUTIONn = 12

Phase 11Phase 23Phase 2 / 31Phase 37

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

CompletedPH IIIShandong Luoxin Pharmaceutical Group Stock Co., Ltd.n=6482023

An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

CompletedPH IIIKey trialBausch Health Americas, Inc.n=2,2722017

Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

CompletedPH IIIKey trialBausch Health Americas, Inc.n=1,1352017

A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

CompletedPH IIIKey trialBausch Health Americas, Inc.n=1,0542017

An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)

CompletedPH IIIKey trialBausch Health Americas, Inc.n=2,3702016

Recent completions

Trials that read out recently, adding to the completed evidence base.

Pilot Study of GCC Agonists to Identify a Cyclic-GMP Signal in Duodenal Tissue of Volunteers

CompletedPH IUniversity of Wisconsin, Madisonn=432026

CompletedPH IIBausch Health Americas, Inc.n=2182024

CompletedPH IIIShandong Luoxin Pharmaceutical Group Stock Co., Ltd.n=6482023

CompletedPH IIBausch Health Americas, Inc.n=1242018

An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

CompletedPH IIIKey trialBausch Health Americas, Inc.n=2,2722017

Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

CompletedPH IIIKey trialBausch Health Americas, Inc.n=1,1352017

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
ClinicalTrials.gov — clinical trials