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Opioid-induced Constipation

14
Pipeline Programs
10
Companies
18
Clinical Trials
1
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
0
7
3
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

SYMPROICApproved
naldemedine
Unknown Company
oral2017
12M Part D

Competitive Landscape

10 companies ranked by most advanced pipeline stage

Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
4 programs
1
2
MethylnaltrexonePhase 41 trial
methylnaltrexonePhase 41 trial
MethylnaltrexonePhase 31 trial
MethylnaltrexoneN/A1 trial
Active Trials
NCT01368562Completed26Est. Jun 2008
NCT01186770Completed804Est. Sep 2011
NCT00672477Completed237Est. Feb 2013
+1 more trials
Shionogi
ShionogiJapan - Osaka
3 programs
3
NaldemedinePhase 31 trial
NaldemedinePhase 31 trial
NaldemedinePhase 31 trial
Active Trials
NCT01993940Completed553Est. Jun 2015
NCT01965652Completed1,246Est. Jan 2016
NCT01965158Completed547Est. Jan 2015
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
2 programs
1
NKTR-118Phase 31 trial
Assessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced ConstipationN/A1 trial
Active Trials
NCT01645371Completed79Est. Feb 2013
NCT01384292Terminated14Est. Sep 2012
Sandoz
SandozAustria - Kundl
2 programs
2
TegaserodPhase 31 trial
TegaserodPhase 31 trial
Active Trials
NCT00414024Terminated11Est. May 2007
NCT00399659Terminated360Est. Apr 2007
Alkermes
AlkermesDUBLIN 4, Ireland
3 programs
3
ALKS 37Phase 21 trial
RDC-1036Phase 21 trial
methylnaltrexonePhase 2
Active Trials
NCT01382797Completed157Est. Apr 2012
NCT01100151Completed60Est. Dec 2010
Pfizer
PfizerNEW YORK, NY
1 program
1
Methylnaltrexone bromidePhase 2
Kyowa Hakko Kirin
Kyowa Hakko KirinCA - La Jolla
2 programs
Clinical assessmentN/A1 trial
Treatment algorithm for OICN/A1 trial
Active Trials
NCT04350112Completed1,007Est. Aug 2019
NCT04404933Completed100Est. Aug 2019
Ironwood Pharmaceuticals
1 program
Linaclotide 145 microgramsPHASE_21 trial
Active Trials
NCT02270983Completed254Est. Oct 2015
Chia Tai TianQing Pharmaceutical Group
1 program
MethylnaltrexonePHASE_2_31 trial
Active Trials
NCT02574819Unknown198Est. Apr 2017
Merck & Co.
Merck & Co.RAHWAY, NJ
1 program
CB-5945PHASE_31 trial
Active Trials
NCT01901341Terminated44Est. Feb 2014

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Bausch Healthmethylnaltrexone
Bausch HealthMethylnaltrexone
ShionogiNaldemedine
ShionogiNaldemedine
ShionogiNaldemedine
Merck & Co.CB-5945
AstraZenecaNKTR-118
Bausch HealthMethylnaltrexone
SandozTegaserod
SandozTegaserod
Chia Tai TianQing Pharmaceutical GroupMethylnaltrexone
Ironwood PharmaceuticalsLinaclotide 145 micrograms
AlkermesALKS 37
AlkermesRDC-1036
Kyowa Hakko KirinClinical assessment

Showing 15 of 18 trials with date data

Clinical Trials (18)

Total enrollment: 5,697 patients across 18 trials

NCT00858754Bausch Healthmethylnaltrexone

Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

Start: Mar 2009Est. completion: Aug 20090
Phase 4Withdrawn
NCT00672477Bausch HealthMethylnaltrexone

Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

Start: Jun 2008Est. completion: Feb 2013237 patients
Phase 4Completed
NCT01993940ShionogiNaldemedine

Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation

Start: Nov 2013Est. completion: Jun 2015553 patients
Phase 3Completed
NCT01965652ShionogiNaldemedine

Long Term Safety of Naldemedine

Start: Sep 2013Est. completion: Jan 20161,246 patients
Phase 3Completed
NCT01965158ShionogiNaldemedine

Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation

Start: Aug 2013Est. completion: Jan 2015547 patients
Phase 3Completed
NCT01901341Merck & Co.CB-5945

The Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation

Start: Jul 2013Est. completion: Feb 201444 patients
Phase 3Terminated
NCT01384292AstraZenecaNKTR-118

Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain

Start: Jun 2011Est. completion: Sep 201214 patients
Phase 3Terminated
NCT01186770Bausch HealthMethylnaltrexone

A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain

Start: Sep 2010Est. completion: Sep 2011804 patients
Phase 3Completed
NCT00414024SandozTegaserod

Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.

Start: Feb 2007Est. completion: May 200711 patients
Phase 3Terminated
NCT00399659SandozTegaserod

Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.

Start: Nov 2006Est. completion: Apr 2007360 patients
Phase 3Terminated
NCT02574819Chia Tai TianQing Pharmaceutical GroupMethylnaltrexone

Study of Methylnaltrexone in Opioid-Induced Constipation Patients

Start: Apr 2015Est. completion: Apr 2017198 patients
Phase 2/3Unknown
NCT02270983Ironwood PharmaceuticalsLinaclotide 145 micrograms

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 Pain

Start: Oct 2014Est. completion: Oct 2015254 patients
Phase 2Completed
NCT01382797AlkermesALKS 37

ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

Start: Aug 2011Est. completion: Apr 2012157 patients
Phase 2Completed
NCT01100151AlkermesRDC-1036

ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)

Start: Apr 2010Est. completion: Dec 201060 patients
Phase 2Completed
NCT04350112Kyowa Hakko KirinClinical assessment

Study of Opioid-Induced Constipation 1 Project

Start: Aug 2017Est. completion: Aug 20191,007 patients
N/ACompleted
NCT04404933Kyowa Hakko KirinTreatment algorithm for OIC

Study of Opioid-Induced Constipation 2 Project

Start: Aug 2017Est. completion: Aug 2019100 patients
N/ACompleted
NCT01645371AstraZenecaAssessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation

Assessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation

Start: Aug 2012Est. completion: Feb 201379 patients
N/ACompleted
NCT01368562Bausch HealthMethylnaltrexone

Compassionate Use Study of Methylnaltrexone

Start: Jan 2003Est. completion: Jun 200826 patients
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
10 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.