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Buprenorphine (Subutex)
Buprenorphine (Subutex) is a Partial opioid agonist Small molecule drug developed by Indivior Inc.. It is currently FDA-approved for Opioid use disorder (maintenance treatment), Moderate to severe pain. Also known as: Subutex.
Buprenorphine is a partial opioid agonist that binds to mu-opioid receptors in the brain, reducing cravings and withdrawal symptoms while producing a lower risk of overdose compared to full opioid agonists.
Buprenorphine is a partial opioid agonist that binds to mu-opioid receptors in the brain, reducing cravings and withdrawal symptoms while producing a lower risk of overdose compared to full opioid agonists. Used for Opioid use disorder (maintenance treatment), Moderate to severe pain.
At a glance
| Generic name | Buprenorphine (Subutex) |
|---|---|
| Also known as | Subutex |
| Sponsor | Indivior Inc. |
| Drug class | Partial opioid agonist |
| Target | Mu-opioid receptor (μ-OR) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Addiction Medicine |
| Phase | FDA-approved |
Mechanism of action
Buprenorphine has high affinity and partial agonist activity at the mu-opioid receptor, meaning it binds strongly but produces a submaximal response. This pharmacological profile creates a 'ceiling effect' that limits respiratory depression and overdose risk. It is used primarily for opioid use disorder maintenance treatment and pain management, where it suppresses withdrawal symptoms and reduces illicit opioid use.
Approved indications
- Opioid use disorder (maintenance treatment)
- Moderate to severe pain
Common side effects
- Headache
- Constipation
- Nausea
- Insomnia
- Sweating
- Dizziness
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:
- Buprenorphine (Subutex) CI brief — competitive landscape report
- Buprenorphine (Subutex) updates RSS · CI watch RSS
- Indivior Inc. portfolio CI
Frequently asked questions about Buprenorphine (Subutex)
What is Buprenorphine (Subutex)?
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What is Buprenorphine (Subutex) used for?
Who makes Buprenorphine (Subutex)?
Is Buprenorphine (Subutex) also known as anything else?
What drug class is Buprenorphine (Subutex) in?
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What does Buprenorphine (Subutex) target?
Related
- Drug class: All Partial opioid agonist drugs
- Target: All drugs targeting Mu-opioid receptor (μ-OR)
- Manufacturer: Indivior Inc. — full pipeline
- Therapeutic area: All drugs in Psychiatry / Addiction Medicine
- Indication: Drugs for Opioid use disorder (maintenance treatment)
- Indication: Drugs for Moderate to severe pain
- Also known as: Subutex
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing