Opioid Use Disorder

13
Pipeline Programs
10
Companies
16
Clinical Trials
5 recruiting
2
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Peptide
1100%
+ 14 programs with unclassified modality

On Market (2)

Approved therapies currently available

Braeburn Pharmaceuticals
BRIXADIApproved
buprenorphine
Braeburn Pharmaceuticals
Partial Opioid Agonist [EPC]subcutaneous2023
Alkermes
VIVITROLApproved
naltrexone
Alkermes
intramuscular2006

Competitive Landscape

10 companies ranked by most advanced pipeline stage

Alkermes
AlkermesDUBLIN 4, Ireland
3 programs
2
1
NTX/BUPPhase 31 trial
NaltrexonePhase 31 trial
ERPs with electroencephalographyN/A1 trial
Active Trials
NCT05495984RecruitingEst. Jun 2026
NCT02537574CompletedEst. Jan 2017
NCT02696434CompletedEst. Nov 2017
Braeburn Pharmaceuticals
Braeburn PharmaceuticalsPA - Plymouth Meeting
3 programs
1
1
1
BuprenorphinePhase 41 trial
CAM2038 q1w or q4w exposure to SL BPN/NXPhase 31 trial
CAM2038Phase 21 trial
Active Trials
NCT02710526Completed66Est. Jul 2017
NCT02672111Completed228Est. May 2017
NCT07176351Not Yet Recruiting60Est. Feb 2027
Bicycle Therapeutics
Bicycle TherapeuticsMA - Cambridge
1 program
1
buprenorphine/naloxonePhase 41 trial
Active Trials
NCT05644587TerminatedEst. Nov 2023
T-Therapeutics
T-TherapeuticsUK - Cambridge
2 programs
1
TirzepatidePhase 2Peptide1 trial
Personally-Tailored Opioid-overdose and Medication for opioid use disorderN/A1 trial
Active Trials
NCT06262347CompletedEst. Nov 2024
NCT06651177RecruitingEst. Jun 2027
Astellas
AstellasChina - Shenyang
1 program
1
ASP8082Phase 11 trial
Active Trials
NCT04448561Completed24Est. Sep 2020
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
1
BI 1356225Phase 11 trial
Active Trials
NCT06628622Recruiting60Est. Feb 2027
Element Biosciences
Element BiosciencesCA - San Diego
1 program
1
Naltrexone implant, 14.4 gramsPhase 11 trial
Active Trials
NCT07064564Not Yet RecruitingEst. Mar 2029
Proniras
PronirasWA - Seattle
1 program
1
TezampanelPhase 11 trial
Active Trials
NCT06538558RecruitingEst. Nov 2025
Alliance Pharmaceuticals
1 program
MySafeRxN/A2 trials
Active Trials
NCT04449744Completed19Est. Sep 2021
NCT02942199Completed12Est. Aug 2018
Arrowhead Pharmaceuticals
1 program
SUNN/A1 trial
Active Trials
NCT06827288Recruiting500Est. Mar 2028

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Braeburn PharmaceuticalsBuprenorphine
Bicycle Therapeuticsbuprenorphine/naloxone
AlkermesNaltrexone
Braeburn PharmaceuticalsCAM2038 q1w or q4w exposure to SL BPN/NX
AlkermesNTX/BUP
T-TherapeuticsTirzepatide
Braeburn PharmaceuticalsCAM2038
Element BiosciencesNaltrexone implant, 14.4 grams
Boehringer IngelheimBI 1356225
PronirasTezampanel
AstellasASP8082
Arrowhead PharmaceuticalsSUN
T-TherapeuticsPersonally-Tailored Opioid-overdose and Medication for opioid use disorder
AlkermesERPs with electroencephalography
Alliance PharmaceuticalsMySafeRx

Showing 15 of 16 trials with date data

Clinical Trials (16)

Total enrollment: 969 patients across 16 trials

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

Start: Mar 2026Est. completion: Feb 202760 patients
Phase 4Not Yet Recruiting
NCT05644587Bicycle Therapeuticsbuprenorphine/naloxone

Novel Induction to Buprenorphine/Naloxone

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

Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL

Start: Apr 2016Est. completion: Nov 2017
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

Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)

Start: Aug 2015Est. completion: Jan 2017
Phase 3Completed

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

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

Phase II Pharmacokinetics Study of CAM2038

Start: Feb 2015Est. completion: Jul 201766 patients
Phase 2Completed
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 2029
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 2025
Phase 1Recruiting

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

Adaptive Interventions for Emergency Department Patients With Opioid Use Disorder

Start: Oct 2024Est. completion: Mar 2028500 patients
N/ARecruiting
NCT06262347T-TherapeuticsPersonally-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 2024
N/ACompleted
NCT05495984AlkermesERPs with electroencephalography

Neuroplasticity in Maternal Opioid Use Disorder (OUD)

Start: Jan 2023Est. completion: Jun 2026
N/ARecruiting

Evaluating Adaptive Dispenser Initiation Protocols for MySafeRx During Post-detox Buprenorphine Treatment- a Pilot Study

Start: Jul 2020Est. completion: Sep 202119 patients
N/ACompleted

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

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

Phase Legend

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

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
5 actively recruiting trials targeting 969 patients
10 companies competing in this space