buprenorphine/naloxone

Phase 3Small molecule

Astellas

buprenorphine/naloxone is one of 105 small molecule programs targeting Buprenorphine. It is currently in Phase 3.

Indications

Total Trials

Active Trials

104

Competitors

Pipeline

Status by Indication[3][1]

Indication

BuprenorphineTerminated

OverdoseActive, not recruiting

Drug DependenceActive, not recruiting

Hepatitis CActive, not recruiting

Opioid Use DisorderRecruiting

BuprenorphinePhase 3

Terminated

OverdosePreclinical

Active, not recruiting

Drug DependencePreclinical

Active, not recruiting

Hepatitis CPreclinical

Active, not recruiting

Opioid Use DisorderPhase 3

Recruiting

Competition

Competitive Landscape

48 competitors in Opioid Use Disorder

#DrugCompanyPhaseTrials

Suboxone

IIndivior Inc.

Approved

20 2

Sovaldi

Gilead

Approved

1 3

Dolophine

HHikma Pharmaceuticals LLC

Approved

6 4

Cabenuva

Oxycontin

3 6

Dilaudid

RRhodes Pharmaceuticals, L.P.

Approved

3 7

Lucemyra

BBioCorRx Pharmaceuticals Inc

Approved

2 8

MS Contin

HHikma Pharmaceuticals LLC

Approved

2 9

Narcan

SScienture

Approved

2 10

Cyklokapron

JJ Molner

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2/3Recruiting

Buprenorphine

NCT04893525

Clinical

Trials by Indication[1]

Buprenorphine27 trials

HIV, Buprenorphine, and the Criminal Justice System

Completed·YYale University·N/A·NCT01550341·50 enrolled

Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments

Recruiting·UUniversity of British Columbia·Phase 2/3·NCT04893525·658 enrolled

Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents

Withdrawn·SState University of New York at Buffalo·Phase 4·NCT01015066

Show 24 more trials

Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")

Completed·IIndivior Inc.·Phase 4·NCT00955162·270 enrolled

Interim Buprenorphine Treatment to Bridge Waitlist Delays: Stage II Evaluation

Unknown status·UUniversity of Vermont·Phase 2·NCT03420313·100 enrolled

Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)

Completed·IIndivior Inc.·Phase 4·NCT00684073·60 enrolled

Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone

Completed·NNew York State Psychiatric Institute·Phase 2/3·NCT02294253·30 enrolled

Buprenorphine Combination Tablet Feasibility - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000298

Low-dose Versus a High-dose Sublingual Buprenorphine Induction

Active, not recruiting·FFriends Research Institute, Inc.·Phase 4·NCT05944952·40 enrolled

Buprenorphine Pharmacology Related to Addiction Treatment - 18

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000236

Buprenorphine as a Treatment in Opiate Dependent Pain Patients

Terminated·SState University of New York at Buffalo·Phase 4·NCT00552578·12 enrolled

Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment

Suspended·FFriends Research Institute, Inc.·Phase 3·NCT03616236·320 enrolled

Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals

Terminated·NNew York State Psychiatric Institute·Phase 3·NCT03711318·8 enrolled

Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

Withdrawn·SStony Brook University·Phase 4·NCT03740243

Buprenorphine Induction for Fentanyl Dependent Opioid Users

Withdrawn·MMilton S. Hershey Medical Center·Phase 1·NCT04794790

Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing

Unknown status·UUnited Health Services Hospitals, Inc.··NCT05307458·20 enrolled

Buprenorphine and Naloxone Combination Study - 10

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00015288

Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 1

Completed·UUniversity of California, Los Angeles·Phase 3·NCT00032968·341 enrolled

CBT4CBT for Office Based Buprenorphine

Completed·CCBT4CBT, LLC·Phase 1/2·NCT03580902·51 enrolled

Drug-Drug Interaction Study Between Telaprevir and Buprenorphine

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT01275599·16 enrolled

Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use

Unknown status·MMassachusetts General Hospital·Phase 4·NCT03266445·76 enrolled

Buprenorphine to Improve HIV Care Engagement and Outcomes

Completed·OOregon Health and Science University·Phase 4·NCT01936857·281 enrolled

Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients

Terminated·MMaimonides Medical Center·N/A·NCT01841931·4 enrolled

Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification - 1

Completed·UUniversity of California, Los Angeles·Phase 3·NCT00032955·163 enrolled

Novel Induction to Buprenorphine/Naloxone

Terminated·BBicycle Health·Phase 4·NCT05644587·33 enrolled

Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00015028

A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01396005·21 enrolled

Opioid Use Disorder8 trials

Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075

Completed·—·Phase 1·NCT03248947·71 enrolled

Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder

Recruiting·UUniversity of British Columbia·Phase 2·NCT04234191·50 enrolled

Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1

Recruiting·UUniversity of Pennsylvania·Phase 2·NCT04480554·225 enrolled

Show 5 more trials

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

Completed· Astellas logo

Astellas·Phase 1·NCT04447287·23 enrolled

Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder

Recruiting·NNew York State Psychiatric Institute·Phase 2/3·NCT05011266·180 enrolled

Improving Office Based Treatment of Opioid Use Disorder With Technology

Unknown status·MMedicaSafe, Inc.·N/A·NCT03586466·80 enrolled

Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post-Operative Opioid Use Disorder Symptoms

Withdrawn·MMassachusetts General Hospital·Phase 4·NCT04091009

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

Withdrawn· Astellas logo

Astellas·Phase 2·NCT05062577

Treatment3 trials

Rapid Initiation of Drug Treatment Engagement

Completed·UUniversity of Pennsylvania·Phase 4·NCT03908437·104 enrolled

Comparison of Three Opioid Detoxification Treatment Regimens

Withdrawn·UUniversity of Alabama at Birmingham·Phase 3·NCT03678792

Starting Treatment With Agonist Replacement Therapies (START)

Completed·UUniversity of California, Los Angeles·Phase 4·NCT00315341·1,269 enrolled

Opioid Dependence3 trials

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

Completed·OOrexo AB·Phase 3·NCT01848054·313 enrolled

Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence

Completed·NNational Institute on Drug Abuse (NIDA)·N/A·NCT00134888·8 enrolled

Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence

Completed·PPaolo Mannelli·Phase 2·NCT01690546·38 enrolled

Opiate Dependence3 trials

Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 3·NCT00015171

Buprenorphine/Naloxone for Treatment of Opiate Dependence - 9

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000344·40 enrolled

Trial of Buprenorphine/Naloxone for Opiate Dependence - 2

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000353

15 more indications

Abuse Potential2 trials

Abuse Potential of Buprenorphine/Naloxone

Terminated·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00149539·12 enrolled

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

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00134875·9 enrolled

Chronic pain2 trials

Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain

Terminated·VVA Office of Research and Development·Phase 4·NCT01875848·7 enrolled

Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

Completed·SState University of New York at Buffalo·Phase 4·NCT00879996·54 enrolled

Drug Dependence1 trial

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

Completed·IIndivior Inc.··NCT00725608·339 enrolled

Maintenance Therapy1 trial

Medication Maintenance Therapy in Community Pharmacy Settings

Unknown status·LLifespan·Phase 2/3·NCT04139213·250 enrolled

HIV infection1 trial

Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00270257·1,251 enrolled

Acceptability1 trial

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

Completed·IIndivior Inc.··NCT00723749·384 enrolled

Heroin Dependence1 trial

Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 4·NCT00015340·582 enrolled

Cardiovascular1 trial

Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV

Completed·MMetroHealth Medical Center··NCT03976258·190 enrolled

Back pain1 trial

Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients

Completed·SState University of New York at Buffalo·Phase 4·NCT01559454·19 enrolled

Rehabilitation1 trial

Buprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1

Completed·UUniversity of Pennsylvania·Phase 3·NCT00078130·223 enrolled

Drug1 trial

Dane County Drug Court Study for Addicted Offenders

Completed·UUniversity of Wisconsin, Madison·Phase 3·NCT01843751·24 enrolled

Postoperative Pain Management1 trial

Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients

Withdrawn·MMassachusetts General Hospital·Phase 4·NCT04771689

Drug Abuse1 trial

Medications Development for Drug Abuse Disorders

Completed·JJohns Hopkins University·Phase 1/2·NCT01188421·106 enrolled

Hepatitis C1 trial

Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1

Completed·NNational Institute on Drug Abuse (NIDA)·N/A·NCT00249574·10 enrolled

Opioid Overdose1 trial

Measures to Improve Outcomes After an Opioid Overdose

Withdrawn·NNassima Ait-Daoud Tiouririne··NCT03968237

Sources

References

[1]
ClinicalTrials.gov — 61 trial records for buprenorphine/naloxone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — buprenorphine/naloxone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for buprenorphine/naloxone. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Astellas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Astellas

buprenorphine/naloxone

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Buprenorphine27 trials

Opioid Use Disorder8 trials

Treatment3 trials

Opioid Dependence3 trials

Opiate Dependence3 trials

Abuse Potential2 trials

Chronic pain2 trials

Drug Dependence1 trial

Maintenance Therapy1 trial

HIV infection1 trial

Acceptability1 trial

Heroin Dependence1 trial

Cardiovascular1 trial

Back pain1 trial

Rehabilitation1 trial

Drug1 trial

Postoperative Pain Management1 trial

Drug Abuse1 trial

Hepatitis C1 trial

Opioid Overdose1 trial

References

Drug Info

Quick Facts

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