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High Dose Buprenorphine
High Dose Buprenorphine is a Partial mu-opioid receptor agonist Small molecule drug developed by Rutgers, The State University of New Jersey. It is currently in Phase 3 development for Moderate to severe chronic pain, Opioid use disorder.
High-dose buprenorphine is a partial mu-opioid receptor agonist that provides stronger analgesia and opioid dependence treatment at elevated doses compared to standard formulations.
High-dose buprenorphine is a partial mu-opioid receptor agonist that provides stronger analgesia and opioid dependence treatment at elevated doses compared to standard formulations. Used for Moderate to severe chronic pain, Opioid use disorder.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | High Dose Buprenorphine |
|---|---|
| Sponsor | Rutgers, The State University of New Jersey |
| Drug class | Partial mu-opioid receptor agonist |
| Target | Mu-opioid receptor (OPRM1) |
| Modality | Small molecule |
| Therapeutic area | Pain Management, Addiction Medicine |
| Phase | Phase 3 |
Mechanism of action
Buprenorphine binds to mu-opioid receptors with high affinity but partial agonist activity, meaning it produces a ceiling effect that limits respiratory depression risk. At higher doses, it achieves greater analgesic potency and more effective suppression of opioid withdrawal symptoms while maintaining this safety profile. This makes high-dose formulations suitable for severe pain management and opioid use disorder treatment in patients requiring stronger therapeutic effects.
Approved indications
- Moderate to severe chronic pain
- Opioid use disorder
Common side effects
- Constipation
- Nausea
- Headache
- Dizziness
- Sweating
- Respiratory depression
Key clinical trials
- 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
- A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use (EARLY_PHASE1)
- Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder (PHASE2)
- Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users (PHASE4)
- Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) (PHASE2)
- Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose (PHASE2, PHASE3)
- High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED) (PHASE3)
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:
- High Dose Buprenorphine CI brief — competitive landscape report
- High Dose Buprenorphine updates RSS · CI watch RSS
- Rutgers, The State University of New Jersey portfolio CI
Frequently asked questions about High Dose Buprenorphine
What is High Dose Buprenorphine?
How does High Dose Buprenorphine work?
What is High Dose Buprenorphine used for?
Who makes High Dose Buprenorphine?
What drug class is High Dose Buprenorphine in?
What development phase is High Dose Buprenorphine in?
What are the side effects of High Dose Buprenorphine?
What does High Dose Buprenorphine target?
Related
- Drug class: All Partial mu-opioid receptor agonist drugs
- Target: All drugs targeting Mu-opioid receptor (OPRM1)
- Manufacturer: Rutgers, The State University of New Jersey — full pipeline
- Therapeutic area: All drugs in Pain Management, Addiction Medicine
- Indication: Drugs for Moderate to severe chronic pain
- Indication: Drugs for Opioid use disorder
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing