Opioid-Related Disorders

8
Pipeline Programs
4
Companies
7
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
0
0
4
4
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Alkermes
VIVITROLApproved
naltrexone
Alkermes
intramuscular2006

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Alkermes
AlkermesDUBLIN 4, Ireland
2 programs
2
NaltrexonePhase 41 trial
Naltrexone for extended-release injectable suspensionPhase 41 trial
Active Trials
NCT01471145CompletedEst. Oct 2014
NCT02978417CompletedEst. Jun 2019
Cook Medical
Cook MedicalIN - Bloomington
1 program
1
BuprenorphinePhase 41 trial
Active Trials
NCT00124358UnknownEst. Dec 2008
T-Therapeutics
T-TherapeuticsUK - Cambridge
3 programs
3
Buprenorphine InjectionPhase 31 trial
Buprenorphine InjectionPhase 31 trial
Buprenorphine InjectionPhase 31 trial
Active Trials
NCT03918850CompletedEst. Jan 2025
NCT03911466CompletedEst. Nov 2024
NCT03911739CompletedEst. Dec 2024
Orexo
OrexoNJ - Morristown
1 program
1
Buprenorphine/naloxone sublingual tabletsPhase 31 trial
Active Trials
NCT01848054CompletedEst. Jan 2014

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AlkermesNaltrexone for extended-release injectable suspension
AlkermesNaltrexone
Cook MedicalBuprenorphine
T-TherapeuticsBuprenorphine Injection
T-TherapeuticsBuprenorphine Injection
T-TherapeuticsBuprenorphine Injection
OrexoBuprenorphine/naloxone sublingual tablets

Clinical Trials (7)

NCT02978417AlkermesNaltrexone for extended-release injectable suspension

Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings

Start: Sep 2017Est. completion: Jun 2019
Phase 4Completed
NCT01471145AlkermesNaltrexone

Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT

Start: Jan 2013Est. completion: Oct 2014
Phase 4Completed
NCT00124358Cook MedicalBuprenorphine

Buprenorphine and Integrated HIV Care Evaluation

Start: Aug 2005Est. completion: Dec 2008
Phase 4Unknown
NCT03911739T-TherapeuticsBuprenorphine Injection

Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study

Start: Jun 2021Est. completion: Dec 2024
Phase 3Completed
NCT03911466T-TherapeuticsBuprenorphine Injection

Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study

Start: Jul 2020Est. completion: Nov 2024
Phase 3Completed
NCT03918850T-TherapeuticsBuprenorphine Injection

Medication Treatment for Opioid Use Disorder in Expectant Mothers

Start: Jul 2020Est. completion: Jan 2025
Phase 3Completed
NCT01848054OrexoBuprenorphine/naloxone sublingual tablets

Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence

Start: Jun 2013Est. completion: Jan 2014
Phase 3Completed

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

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