Last reviewed · How we verify
Sublocade
At a glance
| Generic name | Sublocade |
|---|---|
| Also known as | buprenorphine extended-release injection, extended release buprenorphine, buprenorphine extended-release, Extended release buprenorphine |
| Sponsor | Lifespan |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously. ( 5.1 ) Because of the risk of serious harm or death that could result from intravenous self-administra
Common side effects
- Constipation
- Headache
- Nausea
- Injection site pruritus
- Vomiting
- Increased hepatic enzymes
- Fatigue
- Injection site pain
- Sedation
- Somnolence
- ALT > 3 × ULN (SUBLOCADE 300/300 mg)
- AST > 3 × ULN (SUBLOCADE 300/300 mg)
Serious adverse events
- Injection site ulcer (led to discontinuation)
- Severe injection site pruritus
Key clinical trials
- Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
- Chicago Data-driven Opioid Use Disorder Screening, Engagement, Treatment and Planning System (NA)
- Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections (PHASE2)
- Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
- Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People (EARLY_PHASE1)
- Extended-release Buprenorphine as a Novel Low-dose Induction Strategy (PHASE2)
- Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial (NA)
- Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sublocade CI brief — competitive landscape report
- Sublocade updates RSS · CI watch RSS
- Lifespan portfolio CI