Opioid-induced Constipation

13
Pipeline Programs
8
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
5
1
2
5
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

U
METHYLNALTREXONE BROMIDEApproved
methylnaltrexone bromide
Unknown Company
subcutaneous
Bausch Health
RELISTORApproved
methylnaltrexone bromide
Bausch Health
subcutaneous2008

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
6 programs
1
1
3
MethylnaltrexonePhase 41 trial
Methylnaltrexone bromidePhase 41 trial
methylnaltrexonePhase 41 trial
MethylnaltrexonePhase 31 trial
Methylnaltrexone bromidePhase 2
+1 more programs
Active Trials
NCT01368562CompletedEst. Jun 2008
NCT01186770CompletedEst. Sep 2011
NCT00672477CompletedEst. Feb 2013
+2 more trials
M&
Merck & Co.RAHWAY, NJ
1 program
1
CB-5945Phase 31 trial
Active Trials
NCT01901341Terminated44Est. Feb 2014
CT
1 program
1
MethylnaltrexonePhase 2/31 trial
Active Trials
NCT02574819UnknownEst. Apr 2017
Alkermes
AlkermesDUBLIN 4, Ireland
2 programs
2
ALKS 37Phase 21 trial
RDC-1036Phase 21 trial
Active Trials
NCT01382797CompletedEst. Apr 2012
NCT01100151CompletedEst. Dec 2010
Ironwood Pharmaceuticals
1 program
1
Linaclotide 145 microgramsPhase 21 trial
Active Trials
NCT02270983CompletedEst. Oct 2015
Pfizer
PfizerNEW YORK, NY
1 program
1
Methylnaltrexone bromidePhase 22 trials
Active Trials
NCT00804141Completed1,040Est. Sep 2010
NCT00640146Completed37Est. Jan 2009
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
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
Assessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced ConstipationN/A1 trial
Active Trials
NCT01645371Completed79Est. Feb 2013

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Bausch Healthmethylnaltrexone
Bausch HealthMethylnaltrexone bromide
Bausch HealthMethylnaltrexone
Merck & Co.CB-5945
Bausch HealthMethylnaltrexone
PfizerMethylnaltrexone bromide
Chia Tai TianQing Pharmaceutical GroupMethylnaltrexone
Ironwood PharmaceuticalsLinaclotide 145 micrograms
AlkermesALKS 37
AlkermesRDC-1036
PfizerMethylnaltrexone bromide
Kyowa Hakko KirinClinical assessment
Kyowa Hakko KirinTreatment algorithm for OIC
AstraZenecaAssessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation
Bausch HealthMethylnaltrexone

Clinical Trials (15)

Total enrollment: 2,307 patients across 15 trials

NCT00858754Bausch Healthmethylnaltrexone

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

Start: Mar 2009Est. completion: Aug 2009
Phase 4Withdrawn
NCT00672139Bausch HealthMethylnaltrexone bromide

Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness

Start: Jul 2008Est. completion: May 2013
Phase 4Completed
NCT00672477Bausch HealthMethylnaltrexone

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

Start: Jun 2008Est. completion: Feb 2013
Phase 4Completed
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
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 2011
Phase 3Completed
NCT00804141PfizerMethylnaltrexone bromide

Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation

Start: Dec 2008Est. completion: Sep 20101,040 patients
Phase 3Completed
NCT02574819Chia Tai TianQing Pharmaceutical GroupMethylnaltrexone

Study of Methylnaltrexone in Opioid-Induced Constipation Patients

Start: Apr 2015Est. completion: Apr 2017
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 2015
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 2012
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 2010
Phase 2Completed
NCT00640146PfizerMethylnaltrexone bromide

Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures

Start: Oct 2007Est. completion: Jan 200937 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 2008
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

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