Suboxone

(Buprenorphine)

ApprovedSmall molecule

Buprenorphine is used to treat pain and to help people manage opioid addiction by reducing cravings and withdrawal symptoms.[2] Suboxone is currently approved and in use across 35 indications[4].[1]

Suboxone is one of 597 small molecule programs targeting Hepatitis C. It is currently in Approved.

Indications

235

Total Trials

Active Trials

596

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Hepatitis CActive, not recruiting

DementiaActive, not recruiting

Substance Withdrawal SyndromeActive, not recruiting

Complex Regional Pain SyndromeApproved

Morbid ObesityActive, not recruiting

Chronic PancreatitisActive, not recruiting

OverdoseActive, not recruiting

Drug DependenceActive, not recruiting

Psychiatric DisorderApproved

Depressive DisorderApproved

Hepatitis CApproved

Active, not recruiting

DementiaApproved

Active, not recruiting

Substance Withdrawal SyndromePreclinical

Active, not recruiting

Complex Regional Pain SyndromeApproved

Approved

Morbid ObesityPreclinical

Active, not recruiting

Chronic PancreatitisPreclinical

Active, not recruiting

OverdoseApproved

Active, not recruiting

Drug DependenceApproved

Active, not recruiting

Psychiatric DisorderApproved

Approved

Depressive DisorderApproved

Approved

Showing 10 of 35 indications

Competition

Competitive Landscape

181 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Suboxone

IIndivior Inc.

Approved

1 2

Actos

Takeda

Preclinical

2 3

Celexa

AbbVie

Preclinical

1 4

Voltaren

Cataflam

Plaquenil

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 8

Velcade

SShilpa Grover, MD, MPH

Preclinical

2 9

Vancocin

HHikma Pharmaceuticals LLC

Preclinical

1 10

Disalcid

JJoslin Diabetes Center

Preclinical

—

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

Timeline

Expected Milestones

Q4 2026

Recruiting

Bariatric Surgery

NCT03460314

Q1 2027

Phase 3Recruiting

Major Depressive Episode

NCT03646058

Q2 2027

Post-ApprovalNot yet recruiting

Buprenorphine

NCT07469501

Q4 2027

Phase 2/3Recruiting

Opioid Use Disorder

NCT06316830

Clinical

Trials by Indication[1]

Buprenorphine96 trials

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

Study Assessing the Safety and Therapeutic Effect of Buprenorphine in MDD Patients

Unknown status·SShalvata Mental Health Center·Phase 1·NCT01311570·20 enrolled

Methadone/Buprenorphine Cross-Over Study - 4

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000208

Show 93 more trials

Buprenorphine Dose Alteration Study - 1

Completed·UUniversity of Vermont·Phase 1·NCT00000219

Buprenorphine Dose Escalation Trial for Treatment of Non-Dependent Opiate Users - 2

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00015041

Effects of Buprenorphine on Ulnar Nerve Motor Block

Terminated·UUniversity of Zurich·Phase 4·NCT00949299·20 enrolled

Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000318·202 enrolled

Buprenorphine Maintenance for Opioid Addicts - 1

Completed·YYale University·Phase 2·NCT00000202

Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film

Completed·BBioDelivery Sciences International·Phase 2·NCT01871285·39 enrolled

Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

Unknown status·—·Phase 1·NCT00347815·24 enrolled

Buprenorphine for Individuals in Jail

Recruiting·FFriends Research Institute, Inc.·Phase 3·NCT06306443·240 enrolled

Bioequivalence and Adhesion Comparison of Buprenorphine Patches

Completed·MMundipharma Research Limited·Phase 1·NCT02268422·104 enrolled

Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone

Terminated·NNational Institute on Drug Abuse (NIDA)·N/A·NCT00000243·16 enrolled

Study of the Treatment of Experimental Pain in Opioid Dependent Persons on Methadone or Buprenorphine Maintenance

Completed·JJohns Hopkins University·Phase 1·NCT01642030·132 enrolled

Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1/2·NCT00000320·120 enrolled

Efficacy of Buprenorphine for Treatment of Acute Pain

Completed·TTehran University of Medical Sciences·Phase 4·NCT01298297·80 enrolled

Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

Withdrawn·SStony Brook University·Phase 4·NCT03740243

Buprenorphine Pharmacology Related to Addiction Treatment - 21

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000239

Buprenorphine Dosing Interval - 5

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000209

HIV, Buprenorphine, and the Criminal Justice System (STRIDE2)

Completed·YYale University··NCT03583138·159 enrolled

Buprenorphine Maintenance for Opioid Addicts - 2

Completed·YYale University·Phase 2·NCT00000203

Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals

Completed·UUniversity of Arkansas·Phase 2·NCT01262092·30 enrolled

A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality

Unknown status·—·Phase 3·NCT00863291·40 enrolled

Determine the Safety of a Sublingual Tablet Formulation of Buprenorphine and Naloxone by Extending the Combination Tablet Availability to Physicians in Office-Based Practice

Completed·UUS Department of Veterans Affairs·Phase 4·NCT00007527·600 enrolled

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

Completed·UUniversity of California, Los Angeles·Phase 3·NCT00078117·516 enrolled

Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study

Completed·PPurdue Pharma LP·Phase 3·NCT01151098·189 enrolled

Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release

Completed·—·Phase 1/2·NCT00367302·116 enrolled

Buprenorphine Maintenance Dose Schedule and Treatment Setting - 2

Completed·YYale University·Phase 2·NCT00000319

Buprenorphine Maintenance for Cocaine Abusing Opioid Addicts - 1

Completed·YYale University·Phase 3·NCT00000216

Alternate-Day Buprenorphine Administration. Phase IV - 5

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000223

The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects

Withdrawn·BBioDelivery Sciences International·Phase 3·NCT02516436

Efficacy of Buprenorphine on Postoperative Endodontic Analgesia

Terminated·UUniversity Hospitals Cleveland Medical Center·Phase 1·NCT03268278·10 enrolled

Alternate Day Buprenorphine Administration, Phase IX - 14

Completed·UUniversity of Vermont·Phase 2·NCT00000232

A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain

Terminated·MMundipharma Research Limited·Phase 1/2·NCT00947466·25 enrolled

Buprenorphine Detoxification - BBDVI - 19

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000237

Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00218101·10 enrolled

Pharmacokinetic Interactions Between Buprenorphine and Kaletra (Lopinavir/Ritonavir)

Completed·YYale University·N/A·NCT00571961·12 enrolled

A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders

Completed·NNew York State Psychiatric Institute·Phase 3·NCT03232346·11 enrolled

Gradual Vs. Rapid Buprenorphine Detoxification - 2

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00000220

Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

Completed·IINSYS Therapeutics Inc·Phase 3·NCT02634788·322 enrolled

Evaluation of Liquid vs. Tablet Buprenorphine - 6

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000341·1 enrolled

Combined Buprenorphine and Behavioral Treatment With and Without Contingent Reinforcement on Opioid and Cocaine Abstinence. - 22

Completed·UUniversity of Vermont·Phase 2·NCT00000240

Alternate-Day Buprenorphine Administration. Phase II - 4

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00000222

Buprenorphine Detoxification With Two Types of Treatment. BBD III - 12

Completed·UUniversity of Vermont·Phase 2·NCT00000230

Buprenorphine Detox With Two Types of Treatment. BBD I - 10

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000228

Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

Completed·HHospital Italiano de Buenos Aires·Phase 2/3·NCT03380533·50 enrolled

Buprenorphine's Dose Response Curve

Completed·JJohns Hopkins University·Phase 2·NCT00460239·12 enrolled

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

Completed·IIndivior Inc.·Phase 2·NCT02044094·39 enrolled

Effects of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sublingual and Intravenous Buprenorphine

Completed·TTurku University Hospital·Phase 4·NCT01854489·12 enrolled

Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure

Completed·TThomas Jefferson University·Phase 1/2·NCT03608696·10 enrolled

Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain

Completed·BBioDelivery Sciences International·Phase 2·NCT00941304·153 enrolled

Buprenorphine in the Emergency Department

Completed·—·Phase 4·NCT03174067·26 enrolled

Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects

Completed·BBioDelivery Sciences International·Phase 3·NCT01675167·815 enrolled

Long Acting Subcutaneous vs Short Acting Sublingual Buprenorphine in Pregnant and Lactating Women

Withdrawn·OOhio State University·Phase 4·NCT04212065

Alternate-Day Buprenorphine Administration. Phase VI - 7

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000225

Alternate Day Buprenorphine Administration, Phase X - 15

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000233

Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

Terminated·NNew York State Psychiatric Institute·Phase 2/3·NCT03113409·10 enrolled

Study Comparing Liquid and Tablet Buprenorphine Formulations - 5

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 3·NCT00000302

Fetal and Infant Effects of Maternal Buprenorphine Treatment

Completed·JJohns Hopkins University·Phase 2/3·NCT01561079·127 enrolled

Standard Versus High Dose ED-Initiated Buprenorphine Induction

Recruiting·YYale University·Phase 3·NCT06494904·360 enrolled

Buprenorphine and Integrated HIV Care Evaluation

Unknown status·TThe New York Academy of Medicine·Phase 4·NCT00124358·1,350 enrolled

Alternate-Day Buprenorphine Administration. Phase VIII - 9

Completed·UUniversity of Vermont·Phase 2·NCT00000227

Alternate-Day Buprenorphine. Phase V - 6

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00000224

Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects

Completed·BBioDelivery Sciences International·Phase 3·NCT01633944·752 enrolled

Alternate Day Buprenorphine Administration, Phase XI - 16

Completed·UUniversity of Vermont·Phase 2·NCT00000234

High Dosage Buprenorphine as a Drug Strategy Withdrawal Assistance of Analgesics Opioid

Unknown status·UUniversity Hospital, Clermont-Ferrand·Phase 2·NCT03156907·60 enrolled

Buprenorphine Maintenance Protocol - 1

Completed·UUniversity of California, Los Angeles·Phase 3·NCT00000205

Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

Completed·UUniversity of California, Los Angeles·Phase 2·NCT00000299·12 enrolled

Buprenorphine Disposition and Cyclosporine

Completed·WWashington University School of Medicine·N/A·NCT01648270·25 enrolled

Onsite Buprenorphine Treatment at Syringe Exchange Programs

Completed·MMontefiore Medical Center·Phase 2·NCT03150173·97 enrolled

Alternate Day Buprenorphine Administration, Phase XII - 17

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000235

Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

Terminated·IINSYS Therapeutics Inc·Phase 3·NCT02310581·40 enrolled

Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial

Not yet recruiting·PPouya Azar·Phase 4·NCT07439549·12 enrolled

Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users

Completed·IIndivior Inc.·Phase 4·NCT04995029·785 enrolled

Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods

Completed·PPurdue Pharma LP·Phase 1·NCT01259102·70 enrolled

Buprenorphine Detox With Two Types of Treatment. BBD II - 11

Completed·UUniversity of Vermont·Phase 2·NCT00000229

Comparison of Buprenorphine and Methadone - 3

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000334

Buprenorphine Maintenance for Opioid Addicts - 3

Completed·YYale University·Phase 2·NCT00000204

Alternate-Day Buprenorphine Administration. Phase I - 3

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00000221

Drug Interaction & Methadone & Buprenorphine

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02045693·32 enrolled

Effects of Buprenorphine and Naloxone in Opiate Addicts - 4

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00000355

Analgesic Response to Opioid Analgesics in Buprenorphine-Maintained Individuals

Unknown status·UUniversity of California, Los Angeles·N/A·NCT02136784·12 enrolled

Buprenorphine Detoxification With Two Types of Treatment. BBD IV - 13

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000231

Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department

Unknown status·—·Phase 2·NCT03256487·122 enrolled

Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

Completed·YYale University·Phase 2·NCT00023283

Alternate-Day Buprenorphine Administration. Phase VII - 8

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000226

Monthly Versus Daily Buprenorphine Formulations for Treatment of Opiate Use Disorder

Unknown status·RRoyal Victoria Hospital, Canada·Phase 4·NCT05594121·90 enrolled

Emergency Department-Initiated Buprenorphine Validation Network Trial

Completed·YYale University·Phase 2·NCT04225598·2,000 enrolled

The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers

Completed·PPurdue Pharma LP·Phase 1·NCT01148537·132 enrolled

Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07469501·50 enrolled

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

Completed·IIndivior Inc.·Phase 4·NCT05704543·132 enrolled

Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion

Completed·UUniversity of California, San Diego·Phase 4·NCT04254081·57 enrolled

Assessing Optimal XR-Buprenorphine Initiation Points in Jail

Withdrawn·NNYU Langone Health·Phase 4·NCT05481112

Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole

Completed·PPurdue Pharma LP·Phase 1·NCT01259115·20 enrolled

The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers

Completed·PPurdue Pharma LP·Phase 1·NCT01999114·328 enrolled

The Effects of Buprenorphine on Responses to Verbal Tasks

Completed·UUniversity of Chicago·Phase 1·NCT01860287·48 enrolled

Opioid Dependence10 trials

Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence

Completed·NNational Institute on Drug Abuse (NIDA)·N/A·NCT00134914·10 enrolled

Opioid Dependence Treatment Therapies in Pregnancy

Completed·UUniversity of Pittsburgh·N/A·NCT03098407·55 enrolled

Clinical Trial of Integrated Treatment for Pain and Opioid Dependence

Completed·YYale University·Phase 1/2·NCT00634803·90 enrolled

Show 7 more trials

Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care

Completed·NNew York State Psychiatric Institute··NCT00471042·30 enrolled

Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial

Completed·NNew York State Psychiatric Institute·Phase 2/3·NCT00684554·20 enrolled

Improving Treatment Outcomes for Prescription Opioid Dependence

Completed·UUniversity of Arkansas·Phase 2/3·NCT02543944·117 enrolled

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

A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence

Terminated·TTitan Pharmaceuticals·Phase 3·NCT00768482·9 enrolled

Buprenorphine Treatment for Opioid Dependence

Completed·YYale University·Phase 3·NCT02187198·9 enrolled

A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants

Completed·TTitan Pharmaceuticals·Phase 3·NCT02180659·177 enrolled

Opioid Use Disorder9 trials

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

Completed·AAlkermes, Inc.·Phase 3·NCT02696434·101 enrolled

Maternal Brain Imaging in Opioid Use Disorder

Active, not recruiting·IIndiana University··NCT06008990·40 enrolled

Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose

Recruiting·RRhode Island Hospital·Phase 2/3·NCT06316830·250 enrolled

Show 6 more trials

Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine

Unknown status·FFriends Research Institute, Inc.·Phase 2/3·NCT04991974·360 enrolled

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).

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT06406400·15 enrolled

Extended-release Pharmacotherapy for Opioid Use Disorder

Completed·KKing's College London·Phase 3·NCT05164549·342 enrolled

Oral Buprenorphine as a Novel Low-dose Induction Strategy for Opioid Use Disorder

Completed·—·Phase 1·NCT06086275·18 enrolled

The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder

Terminated·MMaineHealth·Phase 4·NCT04981678·12 enrolled

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

Completed·—··NCT03911466·97 enrolled

Osteoarthritis8 trials

Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

Terminated·PPurdue Pharma LP·Phase 3·NCT00312221·418 enrolled

Norspan Transdermal Patches Study in Osteoarthritis Patients

Completed·MMundipharma (China) Pharmaceutical Co. Ltd·Phase 1·NCT01643759·30 enrolled

Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip Knee and/or Lumbar Spine

Completed·NNorpharma A/S·Phase 4·NCT00426647·120 enrolled

Show 5 more trials

Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly

Completed·NNapp Pharmaceuticals Limited·Phase 4·NCT00324038·219 enrolled

Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

Terminated·PPurdue Pharma LP·Phase 3·NCT01135524·196 enrolled

Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee

Completed·PPurdue Pharma LP·Phase 3·NCT00531427·567 enrolled

Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

Terminated·PPurdue Pharma LP·Phase 3·NCT00315458·107 enrolled

Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

Terminated·PPurdue Pharma LP·Phase 3·NCT00320801·188 enrolled

Treatment6 trials

Combining Behavioral Treatment With Agonist Maintenance - 1

Completed·YYale University·Phase 3·NCT00000311·168 enrolled

Diversion to Treatment for Injection Drug Users Arrested for Possession of Heroin

Completed·JJohns Hopkins University·Phase 1·NCT01723527·1 enrolled

Neurocognitive Effects of Opiate Agonist Treatment

Completed·—·Phase 4·NCT01733693·135 enrolled

Show 3 more trials

Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults

Completed·OOrexo AB·Phase 3·NCT01908842·759 enrolled

Optimal Treatment of Veterans With PTSD and Comorbid OUD

Terminated·VVA Office of Research and Development·Phase 2·NCT03605342·38 enrolled

Treatment for Opioid Dependent Offenders

Completed·UUniversity of Wisconsin, Madison·Phase 2/3·NCT01082679·16 enrolled

54 more indications

Low back pain4 trials

Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain

Completed·BBraeburn Pharmaceuticals·Phase 3·NCT02946073·1,053 enrolled

Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

Terminated·PPurdue Pharma LP·Phase 3·NCT00313014·660 enrolled

Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain

Completed·BBioDelivery Sciences International·Phase 3·NCT01256450·334 enrolled

Show 1 more trial

Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015

Terminated·PPurdue Pharma LP·Phase 3·NCT01125917·354 enrolled

Neonatal Abstinence Syndrome3 trials

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Completed·TThomas Jefferson University·Phase 1·NCT00521248·60 enrolled

Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)

Completed·PPediatrix·Phase 2·NCT01708707·29 enrolled

Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome

Completed·TThomas Jefferson University·Phase 3·NCT01452789·63 enrolled

Treatment Resistant Depression3 trials

Buprenorphine Used With Treatment Resistant Depression in Older Adults

Completed·WWashington University School of Medicine·Phase 1/2·NCT02181231·18 enrolled

Buprenorphine for Late-Life Treatment Resistant Depression

Completed·UUniversity of Pittsburgh·Phase 2·NCT01071538·15 enrolled

Buprenorphine for Treatment Resistant Depression

Completed·UUniversity of Pittsburgh·Phase 3·NCT01407575·13 enrolled

Prevention3 trials

Treatment Efficacy for Drug Abuse and AIDS Prevention - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000210

Relapse Prevention to Reduce HIV Among Women Prisoners

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT00763958·44 enrolled

Treatment Efficacy for Drug Abuse and AIDS Prevention - 2

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000211

Efficacy and Safety3 trials

Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)

Completed·MMundipharma Korea Ltd·Phase 4·NCT01983111·136 enrolled

An Interventional Study to Assess the Efficacy and Safety of Buprenorphine in Korean Patients With Spinal Disorders

Completed·MMundipharma Korea Ltd·Phase 4·NCT01818700·245 enrolled

Norspan Efficacy and Safety Among Elderly Subjects

Completed·MMundipharma AB·Phase 4·NCT01276431·102 enrolled

Cancer Pain2 trials

Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research··NCT01946555·150 enrolled

Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain

Completed·TTaiwan Mundipharma Pharmaceuticals Ltd.··NCT04315831·83 enrolled

Chronic pain2 trials

Prospective Study About Clinical and Pharmacogenetic Safety of Opioid Use for Chronic Pain

Suspended·FFondazione IRCCS Policlinico San Matteo di Pavia·Phase 4·NCT00916890·320 enrolled

Sublingual Buprenorphine for Chronic Pain

Unknown status·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00612287·40 enrolled

Opioid2 trials

Extended Release Naltrexone for Opioid-Dependent Youth

Completed·FFriends Research Institute, Inc.·Phase 4·NCT01843023·288 enrolled

Improved Strategies for Outpatient Opioid Detoxification

Completed·NNew York State Psychiatric Institute·Phase 1·NCT01377610·150 enrolled

Opioid Withdrawal2 trials

Feasibility of the Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal

Completed·VVirginia Commonwealth University·Phase 1·NCT03489161·3 enrolled

A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

Completed·JJohns Hopkins University·Phase 1/2·NCT01136356·12 enrolled

Complete Response2 trials

Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine

Completed·CCentre for Addiction and Mental Health·Phase 1/2·NCT02263248·56 enrolled

Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine

Completed·—·Phase 2·NCT02176291·31 enrolled

Abuse Potential2 trials

Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users

Completed·NNational Institute on Drug Abuse (NIDA)·N/A·NCT00158236·7 enrolled

Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

Recruiting·VVanderbilt University Medical Center·Phase 4·NCT05988710·120 enrolled

Mucositis1 trial

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients

Completed·MMedical College of Wisconsin·Phase 2·NCT04752384·20 enrolled

Analgesic Efficacy1 trial

RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder.

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 4·NCT01809106·518 enrolled

Bariatric Surgery1 trial

Bariatric Surgery and Pharmacokinetics of Buprenorphine

Recruiting·NNorwegian University of Science and Technology··NCT03460314·12 enrolled

Schizophrenia1 trial

Low-dose Buprenorphine as a Modulator of Social Motivation in Schizophrenia

Recruiting·UUniversity of California, Los Angeles·Phase 2·NCT05778591·40 enrolled

Musculoskeletal Pain1 trial

Study of the Treatment of Experimental Pain in Buprenorphine Maintained Persons With Chronic Musculoskeletal Pain

Completed·JJohns Hopkins University·Phase 1·NCT02372591·14 enrolled

Experimental1 trial

Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain

Completed·UUniversity of Aarhus·Phase 3·NCT00647127·22 enrolled

Adult1 trial

Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution

Completed·JJohns Hopkins University·Phase 1·NCT01560221·38 enrolled

Complex Regional Pain Syndrome1 trial

Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome Patients

Unknown status·SSeoul National University Hospital··NCT03977012·20 enrolled

Opioid Use1 trial

A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users

Completed·AAlkermes, Inc.·Phase 1·NCT02413281·56 enrolled

Adolescent1 trial

Science-Based Treatment for Opioid-Dependent Adolescents

Unknown status·—·Phase 2·NCT00182572·80 enrolled

Suicide1 trial

Opiate Suicide Study in Patients With Major Depression

Active, not recruiting·SStanford University·Phase 3·NCT04116528·60 enrolled

Completed·JJohns Hopkins University·Phase 2·NCT03492099·47 enrolled

Withdrawal1 trial

Treatment of Polydrug-Using Opiate Dependents During Withdrawal

Completed·SSorlandet Hospital HF·Phase 4·NCT00367874·12 enrolled

Observational Study1 trial

Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)

Completed·IIndivior Inc.··NCT00723697·1,307 enrolled

Dementia1 trial

Efficacy of Pain Treatment on Depression in Patients With Dementia

Completed·UUniversity of Bergen·Phase 4·NCT02267057·163 enrolled

Analgesic1 trial

Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID: 855509)

Terminated·GGrünenthal GmbH·Phase 1·NCT00469053·36 enrolled

Postoperative Pain Control1 trial

Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery

Completed·SSeoul National University Hospital·Phase 4·NCT02416804·69 enrolled

Post Operative Pain1 trial

Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur

Completed·VVejle Hospital·Phase 4·NCT00964808·76 enrolled

Randomized Controlled Trial1 trial

A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction

Completed·TTitan Pharmaceuticals·Phase 3·NCT01114308·287 enrolled

Outcome1 trial

Temporal Discounting Delayed Outcomes on Opioid-Dependent Outpatients - 20

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000238

Knee Arthroplasty1 trial

Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty

Completed·KKuopio University Hospital·Phase 4·NCT02575664·160 enrolled

Clinical Trial1 trial

Multicenter Clinical Trial of Buprenorphine - 3

Completed·UUniversity of California, Los Angeles·Phase 3·NCT00000207

Tuberculosis1 trial

Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications

Completed·UUniversity of California, San Francisco·Phase 1·NCT00877591·63 enrolled

Single Dose1 trial

Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID 297307)

Terminated·GGrünenthal GmbH·Phase 1·NCT00469404·24 enrolled

Substance Abuse1 trial

Project BEST: Buprenorphine Entry Into Substance Abuse Treatment

Completed·YYale University··NCT02583243·209 enrolled

Rheumatoid Arthritis1 trial

Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain

Completed·MMundipharma Pte Ltd.·Phase 4·NCT01961271·114 enrolled

Fasting Conditions1 trial

Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT01157169·40 enrolled

Local Anesthetic1 trial

Duration of Analgesic Effect for Ultrasound Guided Supraclavicular Blocks With the Addition of Buprenorphine to Local Anesthetic Solution

Terminated·UUniversity of Wisconsin, Madison·N/A·NCT01583179·26 enrolled

Hemodialysis1 trial

HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT04571619·643 enrolled

Phase 21 trial

A Bundled Intervention - Phase 2

Not yet recruiting·UUniversity of Alabama at Birmingham·Phase 4·NCT07485335·160 enrolled

Pain1 trial

Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

Completed·PPurdue Pharma LP·Phase 3·NCT01141283·290 enrolled

Hepatitis C1 trial

Buprenorphine Versus Methadone Maintenance in Hepatitis C Patients Receiving Peg-Intron and Rebetol (Study P04279)(TERMINATED)

Terminated·IIndivior Inc.·Phase 4·NCT00279565·128 enrolled

Major Depressive Episode1 trial

Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode

Recruiting·—·Phase 3·NCT03646058·180 enrolled

Nerve Block1 trial

Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)

Completed·HHospital for Special Surgery, New York·Phase 1·NCT02198235·90 enrolled

Opioid-induced Hyperalgesia1 trial

The Effects of Opioid Taper on Opioid-Induced Hyperalgesia

Terminated·GGeorgetown University··NCT03063905·15 enrolled

Pregnant Women1 trial

RCT Comparing Methadone and Buprenorphine in Pregnant Women

Completed·JJohns Hopkins University·Phase 3·NCT00271219·175 enrolled

Renal Colic1 trial

Buprenorphine in Acute Renal Colic Pain Management

Completed·TTehran University of Medical Sciences·Phase 4·NCT01546701·80 enrolled

Trial1 trial

Monthly Injectable BUP for MA Use Disorder (MURB) Trial

Terminated·MMadhukar H. Trivedi, MD·Phase 2·NCT05283304·18 enrolled

Randomised Controlled Trial1 trial

Role of Preoperative Transdermal Buprenorphine Patch in Reducing Postoperative Opioids Consumption in Patients Undergoing Total Knee Arthroplasties - A Randomised Controlled Trial.

Unknown status·SSecurity Forces Hospital·Phase 4·NCT05042648·120 enrolled

Postoperative Analgesia1 trial

Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy

Active, not recruiting·Mmedina medical center·Phase 4·NCT06742554·70 enrolled

Unspecified1 trial

Clinical Rescue Protocol - 2

Completed·UUniversity of California, Los Angeles·Phase 2·NCT00000206

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

BUPRENEX

NDA NDA018401

Oct 8, 2002

SUBUTEX

NDA NDA020732

Jun 30, 2010

BUTRANS

NDA NDA021306

Oct 23, 2015

BELBUCA

NDA NDA207932

May 26, 2016

PROBUPHINE

NDA NDA204442

Nov 30, 2017

SUBLOCADE

NDA NDA209819

May 23, 2023

BRIXADI

NDA NDA210136

Sources

References

[1]
ClinicalTrials.gov — 235 trial records for Buprenorphine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Suboxone drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Buprenorphine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Buprenorphine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210136). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Suboxone. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Indivior Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Kappa Opioid Receptor Agonist; Mu Opioid Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: IIndivior Inc.

Patent Landscape[6]

Patent Cliff

Jan 10, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8236755Jul 31, 2026

8236292Jan 10, 2027

9827241Jun 6, 2031

9272044Jun 6, 2031

9498432Jun 6, 2031

17 more patents

10198218Jun 6, 2031

10592168Jun 6, 2031

9782402Jun 6, 2031

10558394Jun 25, 2031

8975270Sep 5, 2031

8921387Jan 6, 2032

10912772Jul 26, 2032

11135215Jul 26, 2032

12161640Jul 26, 2032

11110084Jul 26, 2032

12318379Jul 26, 2032

9937164Jul 26, 2032

9901539Dec 21, 2032

12622904Nov 6, 2035

11000520Nov 6, 2035

11839611Nov 6, 2035

10646484Jun 22, 2038

Suboxone

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q4 2027

Trials by Indication[1]

Buprenorphine96 trials

Opioid Dependence10 trials

Opioid Use Disorder9 trials

Osteoarthritis8 trials

Treatment6 trials

Low back pain4 trials

Neonatal Abstinence Syndrome3 trials

Treatment Resistant Depression3 trials

Prevention3 trials

Efficacy and Safety3 trials

Cancer Pain2 trials

Chronic pain2 trials

Opioid2 trials

Opioid Withdrawal2 trials

Complete Response2 trials

Abuse Potential2 trials

Mucositis1 trial

Analgesic Efficacy1 trial

Bariatric Surgery1 trial

Schizophrenia1 trial

Musculoskeletal Pain1 trial

Experimental1 trial

Adult1 trial

Complex Regional Pain Syndrome1 trial

Opioid Use1 trial

Adolescent1 trial

Suicide1 trial

Opiate Dependence1 trial

Cocaine Abuse1 trial

Sickle Cell Disease1 trial

Withdrawal1 trial

Observational Study1 trial

Dementia1 trial

Analgesic1 trial

Postoperative Pain Control1 trial

Post Operative Pain1 trial

Randomized Controlled Trial1 trial

Outcome1 trial

Knee Arthroplasty1 trial

Clinical Trial1 trial

Tuberculosis1 trial

Single Dose1 trial

Substance Abuse1 trial

Rheumatoid Arthritis1 trial

Fasting Conditions1 trial

Local Anesthetic1 trial

Hemodialysis1 trial

Phase 21 trial

Pain1 trial

Hepatitis C1 trial

Major Depressive Episode1 trial

Nerve Block1 trial

Opioid-induced Hyperalgesia1 trial

Pregnant Women1 trial

Renal Colic1 trial

Trial1 trial

Randomised Controlled Trial1 trial

Postoperative Analgesia1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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