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Opioid-Induced Constipation (OIC)

8
Pipeline Programs
3
Companies
7
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

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

On Market (1)

Approved therapies currently available

SYMPROICApproved
naldemedine
Unknown Company
oral2017
12M Part D

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Shionogi
ShionogiJapan - Osaka
2 programs
1
1
NaldemedinePhase 41 trial
NaldemedinePhase 1/21 trial
Active Trials
NCT05588323Recruiting24Est. Jun 2026
NCT07038551Recruiting120Est. Sep 2027
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
4 programs
4
NKTR-118Phase 31 trial
NKTR-118Phase 31 trial
NKTR-118Phase 31 trial
NKTR-118Phase 31 trial
Active Trials
NCT01395524Completed302Est. Sep 2012
NCT01309841Completed652Est. Aug 2012
NCT01336205Completed844Est. Dec 2012
+1 more trials
Theravance Biopharma
1 program
1
TD-1211Phase 21 trial
Active Trials
NCT01333540Completed69Est. Jun 2012

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
ShionogiNaldemedine
AstraZenecaNKTR-118
AstraZenecaNKTR-118
AstraZenecaNKTR-118
AstraZenecaNKTR-118
Theravance BiopharmaTD-1211
ShionogiNaldemedine

Clinical Trials (7)

Total enrollment: 2,711 patients across 7 trials

Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study

Start: Jun 2025Est. completion: Sep 2027120 patients
Phase 4Recruiting

A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation

Start: Jul 2011Est. completion: Sep 2012302 patients
Phase 3Completed

Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

Start: Apr 2011Est. completion: Dec 2012844 patients
Phase 3Completed

Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

Start: Mar 2011Est. completion: Sep 2012700 patients
Phase 3Completed

Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

Start: Mar 2011Est. completion: Aug 2012652 patients
Phase 3Completed

A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation

Start: May 2011Est. completion: Jun 201269 patients
Phase 2Completed

Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

Start: Jan 2023Est. completion: Jun 202624 patients
Phase 1/2Recruiting

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

4 late-stage (Phase 3) programs, potential near-term approvals
2 actively recruiting trials targeting 2,711 patients
3 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.