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Drug

Buprenorphine

Approved · FDA / EMA
ClassMu opioid receptor agonistEmerging researchLate-stage developmentRising momentum
Also known as Belbuca, Brixadi, BuTrans, Bunavail+14 more

Belbuca, Brixadi, BuTrans, Bunavail, Buprenex, Buprenorfina, Buprenorphine-Naloxone, Probuphine, Simbadol, Sublocade, Suboxone, Subutex, Zorbium, Zubsolv, (-)-buprenorphine, Buprenophine, Buprenorphine Hydrochloride, Buprenorphinum.

RxNorm1819ChEMBLCHEMBL511142ATCN07BC01ATCN07BC51ATCN02AE01UNII40D3SCR4GZ
5
Research papers
16
Active clinical trials
2
Protein targets
62
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: BUPRENORPHINE (ANDA204937)

Regulatory2026-07-13FDA

Label change: BUPRENORPHINE (ANDA204937)

Regulatory2026-07-13FDA

Label change: BUPRENORPHINE (ANDA204937)

Regulatory2026-07-13FDA

Rapid Outpatient Low-dose Initiation of Buprenorphine for Individuals With OUD Using Fentanyl

Clinical trial2026-07-10Results expected Q4 2026 · ClinicalTrials.gov

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study With a Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine With or Without Naloxone in Early Recovery of Participants With Opioid Use Disorder (RENEW-Op-1)

Clinical trial2026-07-07Results expected Q1 2028 · ClinicalTrials.gov

Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department: a Randomized Controlled Study

Clinical trial2026-06-29Results expected Q4 2026 · ClinicalTrials.gov

Buprenorphine Group Medical Visits for Drug Users at Risk for HIV

Clinical trial2026-06-22Results posted · ClinicalTrials.gov

Supplemental approval: BUPRENORPHINE (ANDA204937)

Regulatory2026-06-18FDA

Opioid use disorder: current trends and potential treatments.

Research2024-01-25Frontiers in public health

Open-label investigation of rapid initiation of extended-release buprenorphine in patients using fentanyl and fentanyl analogs.

Research2023-11-08The American journal on addictions

Open-label, rapid initiation pilot study for extended-release buprenorphine subcutaneous injection.

Research2022-08-24The American journal of drug and alcohol abuse

Pharmacometric dose optimization of buprenorphine in neonatal opioid withdrawal syndrome.

Research2021-09-16Clinical and translational science

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Buprenorphine
Aliases & brands
BelbucaBrixadiBuTransBunavailBuprenexBuprenorfinaBuprenorphine-NaloxoneProbuphineSimbadolSublocadeSuboxoneSubutexZorbiumZubsolv(-)-buprenorphineBuprenophineBuprenorphine HydrochlorideBuprenorphinum
RxNorm CUI
1819
ChEMBL ID
CHEMBL511142
ATC codes
N07BC01N07BC51N02AE01
UNII
40D3SCR4GZ
Primary mechanism
Mu opioid receptor agonist
Regulatory jurisdictions
emafda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Mu-type opioid receptor
OPRM1 · P35372
AGONISTMu opioid receptor agonist
Kappa-type opioid receptor
OPRK1 · P41145
AGONISTKappa opioid receptor agonist

Regulatory timeline

62 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2017-08-14 → 2018-11-20)
Approval / market entry confirmed across FDA and EMA (2024-10-31 → 2026-06-18)
Earliest approval
2006-09-26
Latest approval
2026-06-18
Authorities
FDA · EMA
Total events
62
fdaU.S. Food and Drug Administration· 57 events
2026-07-13Label change
Label change: BUPRENORPHINE (ANDA204937)
Evidence ↗
2026-07-13Label change
Label change: BUPRENORPHINE (ANDA204937)
Evidence ↗
2026-07-13Label change
Label change: BUPRENORPHINE (ANDA204937)
Evidence ↗
emaEuropean Medicines Agency· 5 events
2025-06-19Market withdrawalMarket
Market withdrawal: Sixmo (EMA)
Indication: Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a… Show full indication

Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.

Evidence ↗
2024-12-19ApprovalMulti-authority
Approval: Buprenorphine Neuraxpharm (EMA)
Indication: Substitution treatment of opioid drug dependence, within a comprehensive therapeutic monitoring framework of medical, social and psychological treatment. Treatment is intended for… Show full indication

Substitution treatment of opioid drug dependence, within a comprehensive therapeutic monitoring framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents 15 years of age and older, who have agreed to be treated for addiction.

Evidence ↗
2018-11-20ApprovalMulti-authority
Approval: Buvidal (EMA)

Indication: Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

187 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
187
registered trials across all phases
LATEST COMPLETION 2026
16
Active studies
16
Recruiting
93
Late-stage (III+)
139
Completed
32
Discontinued
PHASE DISTRIBUTIONn = 187
Early Phase 12Phase 127Phase 1 / 29Phase 256Phase 2 / 38Phase 335Phase 439Phase N / A11

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Implementation and Effectiveness of A Bundled Intervention to End Opioid Overdoses by Increasing Treatment Uptake Post Discharge

Not yet recruitingPH IVUniversity of Alabama at Birminghamn=1602030

Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings

Not yet recruitingPH IVDuke Universityn=4502030

Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment - A Pragmatic Hybrid Effectiveness/Implementation Trial

RecruitingPH IVYale Universityn=6002028

Injectable Buprenorphine During Transition Out of Prison: A Partially Randomized Preference Pilot Trial

RecruitingPH IVLifespann=602027

Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic: A Pilot Study

Not yet recruitingPH IVYale Universityn=602027

Recent completions

Trials that read out recently, adding to the completed evidence base.

Neurocomputational Mechanisms of Mood Improvement

CompletedPH IVMarta Peciña, MD PhDn=1202026

Opioid Use Disorder Treatment Linkage at Strategic Touchpoints Using Buprenorphine

CompletedPH II/IIIFriends Research Institute, Inc.n=3732026

An Open-label, Multicentre Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Repeated Doses of INDV-6001 in Adults With Moderate to Severe Opioid Use Disorder

CompletedPH IIIndivior Inc.n=1232026

Oral Buprenorphine as a Novel Low-Dose Induction Strategy for Individuals With Opioid Use Disorder

CompletedPH IBrigham and Women's Hospitaln=182025

Opiate Suicide Study in Patients With Major Depression

CompletedPH IIIStanford Universityn=502025

Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations

CompletedPH IIIT. John Winhusen, PhDn=1402025

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20102024
Major research themes6
Buprenorphine3Opioid-Related Disorders3Dose-Response Relationship, Drug1Drug Overdose1Opiate Substitution Treatment1Substance Withdrawal Syndrome1
Journals, researchers & institutions
Top journals
  • Clinical and translational science1
  • Frontiers in public health1
  • Journal of acquired immune deficiency syndromes (1999)1
  • The American journal of drug and alcohol abuse1
  • The American journal on addictions1
Leading researchers
  • Dobbins RL2
  • Hassman H2
  • Heath A2
  • Adeniyi-Jones SC1
  • Altice FL1
  • Andrews L1
  • Blum K1
  • Boyett B1
Leading institutions
free-text, unnormalised
  • Hassman Research Institute2
  • Behavioral Neuropharmacology and Neuroimaging Laboratory on Addictions1
  • Brigham and Women's Hospital1
  • Center for Sports1
  • Children's Hospital of Philadelphia1
  • Columbia University Irving Medical Center1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Naloxone

Studied across 2 of the same disease areas as Buprenorphine in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.