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Opioid-Related Disorders

15
Pipeline Programs
12
Companies
22
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
0
6
4
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

Indivior
SUBLOCADEApproved
buprenorphine
Indivior
Partial Opioid Agonist [EPC]subcutaneous2017
38M Part D
LOFEXIDINE HYDROCHLORIDEApproved
lofexidine
Unknown Company
oral2025

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
8 programs
2
4
1
LAAMPhase 41 trial
BuprenorphinePhase 31 trial
BuprenorphinePhase 31 trial
BuprenorphinePhase 31 trial
Injectable extended-release buprenorphinePhase 31 trial
+3 more programs
Active Trials
NCT01344122Completed20Est. Sep 2013
NCT00000206Completed0
NCT00000299Completed12Est. Nov 2009
+5 more trials
Indivior
IndiviorUK - Slough
4 programs
2
1
Buprenorphine soluble filmPhase 21 trial
Buprenorphine/naloxone Film StripPhase 21 trial
Buprenorphine/NaloxoneN/A1 trial
buprenorphine/naloxoneN/A1 trial
Active Trials
NCT00723749Completed384Est. Dec 2010
NCT00725608Completed339Est. Apr 2011
NCT00637000Completed38Est. Sep 2008
+1 more trials
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
2 programs
1
1
BuprenorphinePhase 4
Injectable extended-release buprenorphinePhase 3
Britannia Pharmaceuticals
1 program
1
LofexidinePhase 31 trial
Active Trials
NCT00032942Completed66
Acura Pharmaceuticals
1 program
1
hydrocodone bitartrate/acetaminophenPhase 21 trial
Active Trials
NCT01759446Completed44Est. Apr 2013
T-Therapeutics
T-TherapeuticsUK - Cambridge
3 programs
Buprenorphine InjectionPHASE_31 trial
Buprenorphine InjectionPHASE_31 trial
Buprenorphine InjectionPHASE_31 trial
Active Trials
NCT03911466CompletedEst. Nov 2024
NCT03911739CompletedEst. Dec 2024
NCT03918850CompletedEst. Jan 2025
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
Buprenorphine/naloxoneN/A1 trial
Active Trials
NCT00134875Terminated9Est. Dec 2017
Medtronic
MedtronicNJ - Phillipsburg
1 program
Deep Brain SimulatorN/A1 trial
Active Trials
NCT03950492Active Not Recruiting4Est. Dec 2026
Young BioPharma
Young BioPharmaMA - Lowell
1 program
Harm reduction kioskN/A1 trial
Active Trials
NCT05657106Active Not Recruiting752Est. Jul 2027
Temple Therapeutics
Temple TherapeuticsNetherlands - Geleen
1 program
KPI training onlyN/A
Orexo
OrexoNJ - Morristown
1 program
Buprenorphine/naloxone sublingual tabletsPHASE_31 trial
Active Trials
NCT01848054Completed313Est. Jan 2014
Cook Medical
Cook MedicalIN - Bloomington
1 program
BuprenorphinePHASE_41 trial
Active Trials
NCT00124358Unknown1,350Est. Dec 2008

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Cook MedicalBuprenorphine
Angeles TherapeuticsLAAM
Angeles TherapeuticsInjectable extended-release buprenorphine
T-TherapeuticsBuprenorphine Injection
T-TherapeuticsBuprenorphine Injection
T-TherapeuticsBuprenorphine Injection
OrexoBuprenorphine/naloxone sublingual tablets
Angeles TherapeuticsBuprenorphine
Britannia PharmaceuticalsLofexidine
Angeles TherapeuticsBuprenorphine
Angeles TherapeuticsBuprenorphine
Acura Pharmaceuticalshydrocodone bitartrate/acetaminophen
Angeles TherapeuticsBuprenorphine
IndiviorBuprenorphine soluble film
IndiviorBuprenorphine/naloxone Film Strip

Showing 15 of 22 trials with date data

Clinical Trials (22)

Total enrollment: 4,369 patients across 22 trials

NCT00124358Cook MedicalBuprenorphine

Buprenorphine and Integrated HIV Care Evaluation

Start: Aug 2005Est. completion: Dec 20081,350 patients
Phase 4Unknown
NCT00000300Angeles TherapeuticsLAAM

Feasibility Study of Take-Home LAAM Medication - 3

Start: Mar 19950
Phase 4Completed
NCT06023459Angeles TherapeuticsInjectable extended-release buprenorphine

Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)

Start: Oct 2024Est. completion: Jan 2026140 patients
Phase 3Completed
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 2014313 patients
Phase 3Completed
NCT00078117Angeles TherapeuticsBuprenorphine

Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules - 1

Start: Jun 2003Est. completion: May 2005516 patients
Phase 3Completed
NCT00032942Britannia PharmaceuticalsLofexidine

Lofexidine for Opiate Withdrawal - 1

Start: Apr 200166 patients
Phase 3Completed
NCT00000207Angeles TherapeuticsBuprenorphine

Multicenter Clinical Trial of Buprenorphine - 3

Start: May 19920
Phase 3Completed
NCT00000205Angeles TherapeuticsBuprenorphine

Buprenorphine Maintenance Protocol - 1

Start: Oct 1990Est. completion: Sep 19930
Phase 3Completed
NCT01759446Acura Pharmaceuticalshydrocodone bitartrate/acetaminophen

Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users

Start: Feb 2013Est. completion: Apr 201344 patients
Phase 2Completed
NCT00000299Angeles TherapeuticsBuprenorphine

Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

Start: Oct 2008Est. completion: Nov 200912 patients
Phase 2Completed
NCT00637000IndiviorBuprenorphine soluble film

Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone

Start: Mar 2008Est. completion: Sep 200838 patients
Phase 2Completed
NCT00640835IndiviorBuprenorphine/naloxone Film Strip

Safety and Tolerability of Buprenorphine/Naloxone Film Strips

Start: Feb 2008Est. completion: Oct 2008382 patients
Phase 2Completed
NCT00000206Angeles TherapeuticsBuprenorphine

Clinical Rescue Protocol - 2

Start: Apr 19910
Phase 2Completed
NCT05657106Young BioPharmaHarm reduction kiosk

Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk

Start: Mar 2023Est. completion: Jul 2027752 patients
N/AActive Not Recruiting
NCT03950492MedtronicDeep Brain Simulator

Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder

Start: Sep 2019Est. completion: Dec 20264 patients
N/AActive Not Recruiting
NCT01344122Angeles TherapeuticsKPI training only

Medication-Assisted Treatment Implementation in Community Correctional Environments (MATICCE)

Start: Oct 2010Est. completion: Sep 201320 patients
N/ACompleted
NCT00725608Indiviorbuprenorphine/naloxone

Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)

Start: May 2008Est. completion: Apr 2011339 patients
N/ACompleted
NCT00723749IndiviorBuprenorphine/Naloxone

Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)

Start: Mar 2008Est. completion: Dec 2010384 patients
N/ACompleted
NCT00134875Allergy TherapeuticsBuprenorphine/naloxone

Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers

Start: Dec 2000Est. completion: Dec 20179 patients
N/ATerminated

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

6 late-stage (Phase 3) programs, potential near-term approvals
12 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.