NDASUBCUTANEOUSSOLUTION, EXTENDED RELEASEPriority Review
Approved
Nov 2017
Lifecycle
Peak
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority ReviewSchedule 3
SUBLOCADE (buprenorphine) by Indivior is partial opioid agonists [moa]. Approved for partial opioid agonist [epc]. First approved in 2017.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUBLOCADE is a subcutaneous extended-release solution of buprenorphine, a partial opioid agonist approved by the FDA in November 2017. It is indicated for the treatment of opioid use disorder, providing sustained therapeutic levels through monthly or bi-monthly injections rather than daily oral administration. The partial agonist mechanism balances pain relief and addiction treatment while minimizing euphoric effects and withdrawal potential. SUBLOCADE represents an important option in medication-assisted treatment (MAT), offering improved adherence compared to daily sublingual formulations.
$0.0BPart D
12.1 years to LOEMechanism of Action
Partial Opioid Agonists
Pharmacologic Class:
Partial Opioid Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic
Started Apr 2026
60 enrolled
Opioid Use Disorder
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
Started Dec 2025
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
Started Jan 2025
60 enrolled
Opioid Use Disorder
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Started Jan 2025
32 enrolled
Healthy Volunteer Study
An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders
Started Jan 2025
60 enrolled
Autism Spectrum Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
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.