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Sublingual buprenorphine-naloxone
Buprenorphine is a partial opioid agonist that binds to opioid receptors, while naloxone is an opioid antagonist that blocks opioid receptors.
Buprenorphine is a partial opioid agonist that binds to opioid receptors, while naloxone is an opioid antagonist that blocks opioid receptors. Used for Treatment of opioid use disorder.
At a glance
| Generic name | Sublingual buprenorphine-naloxone |
|---|---|
| Also known as | SL-BUP |
| Sponsor | Yih-Ing Hser |
| Drug class | Opioid partial agonist |
| Target | Opioid receptors |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 3 |
Mechanism of action
Buprenorphine's partial agonism provides analgesia with a ceiling effect, reducing the risk of overdose and dependence. Naloxone's antagonism helps to prevent misuse and overdose by blocking the effects of opioids.
Approved indications
- Treatment of opioid use disorder
Common side effects
- Nausea
- Headache
- Dizziness
- Vomiting
- Fatigue
Key clinical trials
- A Bundled Intervention - Phase 2 (PHASE4)
- INDV-6001 Multiple-Dose Pharmacokinetic Study (PHASE2)
- Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
- Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
- Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation (PHASE4)
- A Study of Brenipatide in Participants With Opioid Use Disorder (PHASE2)
- A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use (EARLY_PHASE1)
- Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial (PHASE4)
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:
- Sublingual buprenorphine-naloxone CI brief — competitive landscape report
- Sublingual buprenorphine-naloxone updates RSS · CI watch RSS
- Yih-Ing Hser portfolio CI