Chronic Idiopathic Constipation

16
Pipeline Programs
5
Companies
15
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
4
2
7
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
7100%
+ 8 programs with unclassified modality

On Market (2)

Approved therapies currently available

U
AMITIZAApproved
lubiprostone
Unknown Company
Chloride Channel Activator [EPC]oral2006
U
LUBIPROSTONEApproved
lubiprostone
Unknown Company
Chloride Channel Activator [EPC]oral2023

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Takeda
TakedaTOKYO, Japan
2 programs
1
1
lubiprostonePhase 41 trial
LubiprostonePhase 2/31 trial
Active Trials
NCT01469819Completed37Est. Feb 2015
NCT01460225Completed19Est. Jan 2011
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
7 programs
2
1
3
PlecanatidePhase 3Peptide1 trial
PlecanatidePhase 3Peptide1 trial
PlecanatidePhase 3Peptide1 trial
plecanatidePhase 2/3Peptide1 trial
PlecanatidePhase 2Peptide1 trial
+2 more programs
Active Trials
NCT03551873CompletedEst. Dec 2018
NCT03120520CompletedEst. Sep 2018
NCT01053962CompletedEst. Aug 2010
+4 more trials
Ferring Pharmaceuticals
Ferring PharmaceuticalsArgentina - Buenos Aires
4 programs
1
3
Elobixibat 10 mgPhase 31 trial
Elobixibat 10 mgPhase 31 trial
Elobixibat 10 mg/dayPhase 31 trial
elobixibatPhase 21 trial
Active Trials
NCT02392546Withdrawn0Est. Apr 2016
NCT01827592Terminated376Est. May 2014
NCT01895543Completed411Est. May 2015
+1 more trials
Ironwood Pharmaceuticals
1 program
1
LinaclotidePhase 3Peptide1 trial
Active Trials
NCT02291679CompletedEst. Aug 2015
SK Life Science
SK Life ScienceNJ - Paramus
1 program
1
YKP10811Phase 21 trial
Active Trials
NCT01989234CompletedEst. Dec 2014

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Takedalubiprostone
Ironwood PharmaceuticalsLinaclotide
Bausch HealthPlecanatide
Bausch HealthPlecanatide
Ferring PharmaceuticalsElobixibat 10 mg
Bausch HealthPlecanatide
Ferring PharmaceuticalsElobixibat 10 mg
Ferring PharmaceuticalsElobixibat 10 mg/day
TakedaLubiprostone
Bausch Healthplecanatide
Bausch HealthPlecanatide
Ferring Pharmaceuticalselobixibat
SK Life ScienceYKP10811
Bausch HealthSP-304 0.3 mg
Bausch HealthPlecanatide

Clinical Trials (15)

Total enrollment: 1,157 patients across 15 trials

NCT01460225Takedalubiprostone

Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation

Start: Sep 2007Est. completion: Jan 201119 patients
Phase 4Completed
NCT02291679Ironwood PharmaceuticalsLinaclotide

Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

Start: Oct 2014Est. completion: Aug 2015
Phase 3Completed
NCT02122471Bausch HealthPlecanatide

12-Week Study of Plecanatide for CIC (The National CIC3 Study)

Start: Apr 2014Est. completion: Jul 2015
Phase 3Completed
NCT01982240Bausch HealthPlecanatide

12-Week Study of Plecanatide for CIC (The CIC3 Study)

Start: Nov 2013Est. completion: Jun 2015
Phase 3Completed
NCT01895543Ferring PharmaceuticalsElobixibat 10 mg

Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

Start: Sep 2013Est. completion: May 2015411 patients
Phase 3Completed
NCT01919697Bausch HealthPlecanatide

Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

Start: Aug 2013Est. completion: Mar 2016
Phase 3Completed
NCT01827592Ferring PharmaceuticalsElobixibat 10 mg

26 Week Efficacy and Safety Trial for Patients With Chronic Idiopathic Constipation

Start: Apr 2013Est. completion: May 2014376 patients
Phase 3Terminated
NCT01833065Ferring PharmaceuticalsElobixibat 10 mg/day

Efficacy and Safety Trial of Elobixibat in Patients With Chronic Idiopathic Constipation

Start: Apr 2013Est. completion: Apr 2014314 patients
Phase 3Terminated
NCT01469819TakedaLubiprostone

Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation

Start: Jun 2012Est. completion: Feb 201537 patients
Phase 2/3Completed
NCT01429987Bausch Healthplecanatide

The Plecanatide Chronic Idiopathic Constipation (CIC) Study

Start: Oct 2011Est. completion: Dec 2012
Phase 2/3Completed
NCT03120520Bausch HealthPlecanatide

An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation

Start: Jan 2017Est. completion: Sep 2018
Phase 2Completed
NCT02392546Ferring Pharmaceuticalselobixibat

Elobixibat Colonic Motor Function Study

Start: Apr 2015Est. completion: Apr 20160
Phase 2Withdrawn
NCT01989234SK Life ScienceYKP10811

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of YKP10811 Capsules Administered Once Daily to Subjects With Chronic Idiopathic Constipation

Start: Oct 2013Est. completion: Dec 2014
Phase 2Completed
NCT01053962Bausch HealthSP-304 0.3 mg

SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation

Start: Mar 2010Est. completion: Aug 2010
Phase 2Completed
NCT03551873Bausch HealthPlecanatide

A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®

Start: Jun 2018Est. completion: Dec 2018
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

7 late-stage (Phase 3) programs — potential near-term approvals
5 companies competing in this space