Last reviewed · How we verify
Standard Buprenorphine Dose
Standard Buprenorphine Dose is a Opioid partial agonist Small molecule drug developed by Rutgers, The State University of New Jersey. It is currently in Phase 3 development for Treatment of opioid use disorder, Pain relief in moderate to severe pain.
Buprenorphine acts as a partial agonist at the mu-opioid receptor, providing pain relief and reducing withdrawal symptoms.
Buprenorphine is a small molecule that acts as a mu opioid receptor agonist, classified as an agonist. It is used to treat conditions such as Opiate Use Disorder, Opioid Use Disorder, and Post-Traumatic Stress Disorders, among others.
-
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 | Standard Buprenorphine Dose |
|---|---|
| Sponsor | Rutgers, The State University of New Jersey |
| Drug class | Opioid partial agonist |
| Target | mu-opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain management |
| Phase | Phase 3 |
Mechanism of action
By binding to the mu-opioid receptor, buprenorphine activates the receptor, but to a lesser extent than full agonists like morphine. This partial agonism reduces the risk of overdose and dependence, while still providing therapeutic benefits.
Approved indications
- Treatment of opioid use disorder
- Pain relief in moderate to severe pain
Common side effects
- Nausea
- Dizziness
- Headache
- Sleep disturbances
- Constipation
Key clinical trials
- Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
- Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment (PHASE4)
- 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)
- Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients (PHASE4)
- A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder (PHASE4)
- Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post-Operative Opioid Use Disorder Symptoms (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:
- Standard Buprenorphine Dose CI brief — competitive landscape report
- Standard Buprenorphine Dose updates RSS · CI watch RSS
- Rutgers, The State University of New Jersey portfolio CI
Frequently asked questions about Standard Buprenorphine Dose
What is Standard Buprenorphine Dose?
How does Standard Buprenorphine Dose work?
What is Standard Buprenorphine Dose used for?
Who makes Standard Buprenorphine Dose?
What drug class is Standard Buprenorphine Dose in?
What development phase is Standard Buprenorphine Dose in?
What are the side effects of Standard Buprenorphine Dose?
What does Standard Buprenorphine Dose target?
Related
- Drug class: All Opioid partial agonist drugs
- Target: All drugs targeting mu-opioid receptor
- Manufacturer: Rutgers, The State University of New Jersey — full pipeline
- Therapeutic area: All drugs in Pain management
- Indication: Drugs for Treatment of opioid use disorder
- Indication: Drugs for Pain relief in moderate to severe pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing