Skip to main content

Opioid Use Disorder

21
Pipeline Programs
25
Companies
45
Clinical Trials
8 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
9
1
5
0
5
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
2100%
+ 45 programs with unclassified modality

Competitive Landscape

23 companies ranked by most advanced pipeline stage

Indivior
IndiviorUK - Slough
13 programs
4
2
4
1
Buprenorphine Extended-Release InjectionPhase 41 trial
RBP-6000Phase 31 trial
SUBLOCADEPhase 31 trial
SUBLOCADEPhase 31 trial
SUBOXONE sublingual filmPhase 31 trial
+8 more programs
Active Trials
NCT05878210Completed12Est. May 2025
NCT05860959Completed480Est. Aug 2025
NCT02559973Completed47Est. Mar 2016
+10 more trials
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
3 programs
1
Extended Release NaltrexonePhase 31 trial
Reentry Incentives and Support for Engagement with Contingency ManagementN/A1 trial
SonaraN/A1 trial
Active Trials
NCT07322588Not Yet Recruiting75Est. Jun 2027
NCT06200740Completed24Est. Dec 2022
NCT01908062Completed51Est. Mar 2015
Astellas
AstellasChina - Shenyang
3 programs
2
1
ASP8062Phase 21 trial
ASP8062Phase 11 trial
ASP8082Phase 11 trial
Active Trials
NCT04447287Completed23Est. Nov 2020
NCT04448561Completed24Est. Sep 2020
NCT05062577Withdrawn0Est. Feb 2023
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
2 programs
1
CannabidiolPhase 21 trial
OUD treatment interventionN/A1 trial
Active Trials
NCT06291090Completed400Est. May 2025
NCT05299944Completed126Est. Aug 2025
Prevail Therapeutics
1 program
1
BrenipatidePhase 2Peptide1 trial
Active Trials
NCT07420283Recruiting465Est. Mar 2028
BioXcel Therapeutics
BioXcel TherapeuticsCT - New Haven
1 program
1
BXCL501Phase 1/21 trial
Active Trials
NCT05712707Active Not Recruiting160Est. Aug 2026
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
2 programs
2
AZD4041Phase 11 trial
MorphinePhase 11 trial
Active Trials
NCT06406400Terminated15Est. Jul 2024
NCT05587998Completed45Est. May 2023
Innovation Pharmaceuticals
1 program
1
Overcoming and Addressing Stigma in Substance Use DisordersPhase 11 trial
Active Trials
NCT06266572Completed19Est. Sep 2023
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
3 programs
Patient Decision AidN/A1 trial
Patient Decision AidN/A1 trial
Quality MeasuresN/A1 trial
Active Trials
NCT03394261Completed72Est. Dec 2018
NCT03568552Completed7,554Est. Aug 2024
NCT07214389Recruiting4,500Est. Dec 2027
Braeburn Pharmaceuticals
Braeburn PharmaceuticalsPA - Plymouth Meeting
3 programs
CAM2038PHASE_21 trial
CAM2038 q1w or q4w exposure to SL BPN/NXPHASE_31 trial
BuprenorphinePHASE_41 trial
Active Trials
NCT02710526Completed66Est. Jul 2017
NCT02672111Completed228Est. May 2017
NCT07176351Not Yet Recruiting60Est. Feb 2027
Alliance Pharmaceuticals
2 programs
MySafeRxN/A1 trial
Remote Motivational EnhancementN/A1 trial
Active Trials
NCT02942199Completed12Est. Aug 2018
NCT05184907Completed25Est. Aug 2023
T-Therapeutics
T-TherapeuticsUK - Cambridge
2 programs
Personally-Tailored Opioid-overdose and Medication for opioid use disorderN/A
TirzepatidePHASE_2Peptide1 trial
Active Trials
NCT06651177RecruitingEst. Jun 2027
Masimo
MasimoIRVINE, CA
1 program
Bridge™ active deviceN/A1 trial
Active Trials
NCT05924945Terminated13Est. Aug 2024
Alkermes
AlkermesDUBLIN 4, Ireland
1 program
ERPs with electroencephalographyN/A1 trial
Active Trials
NCT05495984Recruiting15Est. Jun 2026
Insightec
InsightecFL - Miami
1 program
Exablate Model 4000 Type 2.0/2.1N/A1 trial
Active Trials
NCT06612788Completed5Est. Apr 2025
Prescient Therapeutics
Prescient TherapeuticsAustralia - South Melbourne
1 program
Opioid Used Disorder Risk AssessmentN/A1 trial
Active Trials
NCT07135323Recruiting4,000Est. Nov 2031
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
Personally-Tailored Opioid-overdose and Medication for opioid use disorderN/A1 trial
Active Trials
NCT06262347Completed131Est. Nov 2024
Arrowhead Pharmaceuticals
1 program
SUNN/A1 trial
Active Trials
NCT06827288Recruiting500Est. Mar 2028
Parexel
ParexelMA - Boston
1 program
AZD4041PHASE_1
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
BI 1356225PHASE_11 trial
Active Trials
NCT06628622Recruiting60Est. Feb 2027
Element Biosciences
Element BiosciencesCA - San Diego
1 program
Naltrexone implant, 14.4 gramsPHASE_11 trial
Active Trials
NCT07064564Not Yet Recruiting33Est. Mar 2029
Proniras
PronirasWA - Seattle
1 program
TezampanelPHASE_11 trial
Active Trials
NCT06538558Recruiting40Est. Nov 2025
Bicycle Therapeutics
Bicycle TherapeuticsMA - Cambridge
1 program
buprenorphine/naloxonePHASE_41 trial
Active Trials
NCT05644587Terminated33Est. Nov 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Braeburn PharmaceuticalsBuprenorphine
IndiviorBuprenorphine Extended-Release Injection
Bicycle Therapeuticsbuprenorphine/naloxone
IndiviorSUBLOCADE
IndiviorSUBLOCADE
IndiviorRBP-6000
Braeburn PharmaceuticalsCAM2038 q1w or q4w exposure to SL BPN/NX
IndiviorSUBOXONE sublingual film
Oregon TherapeuticsExtended Release Naltrexone
Prevail TherapeuticsBrenipatide
T-TherapeuticsTirzepatide
IndiviorINDV-2000
Colorado TherapeuticsCannabidiol
AstellasASP8062
Braeburn PharmaceuticalsCAM2038

Showing 15 of 45 trials with date data

Clinical Trials (45)

Total enrollment: 20,859 patients across 45 trials

Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic

Start: Apr 2026Est. completion: Feb 202760 patients
Phase 4Not Yet Recruiting
NCT05704543IndiviorBuprenorphine Extended-Release Injection

Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations

Start: Mar 2023Est. completion: Nov 2023132 patients
Phase 4Completed
NCT05644587Bicycle Therapeuticsbuprenorphine/naloxone

Novel Induction to Buprenorphine/Naloxone

Start: Feb 2023Est. completion: Nov 202333 patients
Phase 4Terminated

Virginia Opioid Treatment-Emergency Department

Start: Jan 2021Est. completion: Dec 20210
Phase 3Withdrawn

Virginia Opioid Overdose Treatment InitiatVE

Start: Jan 2019Est. completion: Feb 202119 patients
Phase 3Terminated

Open-Label Treatment Extension Study

Start: Aug 2016Est. completion: Aug 2017208 patients
Phase 3Completed
NCT02672111Braeburn PharmaceuticalsCAM2038 q1w or q4w exposure to SL BPN/NX

Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder

Start: Nov 2015Est. completion: May 2017228 patients
Phase 3Completed
NCT02510014IndiviorSUBOXONE sublingual film

Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder

Start: Jul 2015Est. completion: Jan 2017775 patients
Phase 3Completed
NCT01908062Oregon TherapeuticsExtended Release Naltrexone

Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study

Start: Jun 2014Est. completion: Mar 201551 patients
Phase 3Completed

A Study of Brenipatide in Participants With Opioid Use Disorder

Start: Feb 2026Est. completion: Mar 2028465 patients
Phase 2Recruiting

Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder

Start: Dec 2025Est. completion: Jun 2027
Phase 2Recruiting

Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder

Start: Jun 2024Est. completion: Nov 2025300 patients
Phase 2Completed

Reducing Pain and Opioid Use With CBD

Start: Mar 2022Est. completion: Aug 2025126 patients
Phase 2Completed

A Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder

Start: Nov 2021Est. completion: Feb 20230
Phase 2Withdrawn

Phase II Pharmacokinetics Study of CAM2038

Start: Feb 2015Est. completion: Jul 201766 patients
Phase 2Completed
NCT02044094IndiviorBuprenorphine

Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder

Start: Nov 2013Est. completion: Jul 201439 patients
Phase 2Completed

Sublingual Dexmedetomidine for Treating Opioid Withdrawal

Start: Feb 2023Est. completion: Aug 2026160 patients
Phase 1/2Active Not Recruiting
NCT07064564Element BiosciencesNaltrexone implant, 14.4 grams

iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers

Start: Apr 2026Est. completion: Mar 202933 patients
Phase 1Not Yet Recruiting

A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine

Start: Jan 2025Est. completion: Feb 202760 patients
Phase 1Recruiting

Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder

Start: Oct 2024Est. completion: Nov 202540 patients
Phase 1Recruiting

Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2).

Start: May 2024Est. completion: Jul 202415 patients
Phase 1Terminated
NCT05974046Indivior[14C]IDV184001AN

Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants

Start: Jul 2023Est. completion: Jul 20237 patients
Phase 1Completed

A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.

Start: Aug 2022Est. completion: May 202345 patients
Phase 1Completed
NCT06266572Innovation PharmaceuticalsOvercoming and Addressing Stigma in Substance Use Disorders

Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment

Start: Sep 2021Est. completion: Sep 202319 patients
Phase 1Completed

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants

Start: Jun 2020Est. completion: Sep 202024 patients
Phase 1Completed

A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder

Start: Jun 2020Est. completion: Nov 202023 patients
Phase 1Completed

Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder

Start: Sep 2015Est. completion: Mar 201647 patients
Phase 1Completed

Single Ascending Dose Study of RBP-6000

Start: Jul 2012Est. completion: Oct 201348 patients
Phase 1Completed

Single-dose, Study of RBP-6000 in Opioid Dependent Individuals

Start: Nov 2010Est. completion: May 201118 patients
Phase 1Completed
NCT07322588Oregon TherapeuticsReentry Incentives and Support for Engagement with Contingency Management

Reentry Incentives and Support for Engagement With Contingency Management

Start: Jan 2026Est. completion: Jun 202775 patients
N/ANot Yet Recruiting

PRoducing Outcome Measures for OTP Quality Improvement

Start: Oct 2025Est. completion: Dec 20274,500 patients
N/ARecruiting
NCT07135323Prescient TherapeuticsOpioid Used Disorder Risk Assessment

AvertD Post-Approval Study

Start: Nov 2024Est. completion: Nov 20314,000 patients
N/ARecruiting

Adaptive Interventions for Emergency Department Patients With Opioid Use Disorder

Start: Oct 2024Est. completion: Mar 2028500 patients
N/ARecruiting
NCT06262347Human BioSciencesPersonally-Tailored Opioid-overdose and Medication for opioid use disorder

Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD

Start: Jun 2024Est. completion: Nov 2024131 patients
N/ACompleted
NCT05878210IndiviorEvaluating the SUBLOCADE Treatment Exit Strategy

Evaluating the SUBLOCADE Treatment Exit Strategy

Start: Nov 2023Est. completion: May 202512 patients
N/ACompleted
NCT06612788InsightecExablate Model 4000 Type 2.0/2.1

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD)

Start: Sep 2023Est. completion: Apr 20255 patients
N/ACompleted
NCT05860959IndiviorSUBLOCADE Long-term Outcomes

SUBLOCADE Long-term Outcomes

Start: Aug 2023Est. completion: Aug 2025480 patients
N/ACompleted
NCT05924945MasimoBridge™ active device

Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

Start: Jun 2023Est. completion: Aug 202413 patients
N/ATerminated
NCT06291090Colorado TherapeuticsOUD treatment intervention

A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision

Start: Jan 2023Est. completion: May 2025400 patients
N/ACompleted
NCT05495984AlkermesERPs with electroencephalography

Neuroplasticity in Maternal Opioid Use Disorder (OUD)

Start: Jan 2023Est. completion: Jun 202615 patients
N/ARecruiting

Remotely Observed Methadone Evaluation

Start: Sep 2022Est. completion: Dec 202224 patients
N/ACompleted
NCT05184907Alliance PharmaceuticalsRemote Motivational Enhancement

Effects of RME on Engagement in Buprenorphine Treatment

Start: May 2022Est. completion: Aug 202325 patients
N/ACompleted

Patient Decision Aid for Opioid Use Disorder

Start: Aug 2020Est. completion: Aug 20247,554 patients
N/ACompleted

Pilot Test of Patient Decision Aid for Opioid Use Disorder

Start: Jun 2018Est. completion: Dec 201872 patients
N/ACompleted

MySafeRx & MedicaSafe Open-Label Buprenorphine Induction and Lapse Evaluation (MyMOBILE)

Start: Nov 2016Est. completion: Aug 201812 patients
N/ACompleted

Related Jobs

Phase Legend

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

Key Insights

5 late-stage (Phase 3) programs, potential near-term approvals
8 actively recruiting trials targeting 20,859 patients
25 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.