Last reviewed · How we verify
Sufentanyl/Levobupivacaine
Sufentanyl/Levobupivacaine is a Opioid agonist and local anesthetic Small molecule drug developed by Brugmann University Hospital. It is currently in Phase 3 development for Pain management during surgery.
Sufentanyl/Levobupivacaine is a combination of a potent opioid analgesic and a local anesthetic.
Sufentanil and levobupivacaine are small molecule interventions used in medical procedures, including epidural anesthesia and surgeries such as elective Caesarean sections and coronary artery bypass. They are also studied in conditions related to pregnancy, including normal pregnancy and abortion.
-
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 | Sufentanyl/Levobupivacaine |
|---|---|
| Sponsor | Brugmann University Hospital |
| Drug class | Opioid agonist and local anesthetic |
| Target | mu-opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Anesthesiology |
| Phase | Phase 3 |
Mechanism of action
Sufentanyl is a highly potent opioid agonist that binds to mu-opioid receptors in the brain, providing analgesia. Levobupivacaine is a local anesthetic that blocks sodium channels in nerve fibers, preventing the transmission of pain signals. The combination of these two agents provides both systemic and local analgesic effects.
Approved indications
- Pain management during surgery
Common side effects
- Respiratory depression
- Nausea and vomiting
- Hypotension
Key clinical trials
- Non-opioid Anesthesia Based on Thoracic Paravertebral Block During Laparoscopic Sleeve Gastrectomy (NA)
- The Immune Response of Breast Cancer Patients Treated With Levobupivacaine Using Paravertebral or Superficial Chest Blocks (NA)
- PIEB-PCEA Versus CEI-PCEA for Labor Analgesia in Nulliparous (NA)
- Multimodal Approach to the Intrathecal Catheter for Obstetric Accidental Dural Puncture
- Lumbar Erector Spinae Plane Block for Back Surgery (PHASE3)
- Study Comparing Dural Puncture Epidural With Epidural and Combined Spinal Epidural Anesthesia for Obstetric Analgesia. (PHASE3)
- Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section (PHASE2)
- Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. (PCEA-IMG) (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:
- Sufentanyl/Levobupivacaine CI brief — competitive landscape report
- Sufentanyl/Levobupivacaine updates RSS · CI watch RSS
- Brugmann University Hospital portfolio CI
Frequently asked questions about Sufentanyl/Levobupivacaine
What is Sufentanyl/Levobupivacaine?
How does Sufentanyl/Levobupivacaine work?
What is Sufentanyl/Levobupivacaine used for?
Who makes Sufentanyl/Levobupivacaine?
What drug class is Sufentanyl/Levobupivacaine in?
What development phase is Sufentanyl/Levobupivacaine in?
What are the side effects of Sufentanyl/Levobupivacaine?
What does Sufentanyl/Levobupivacaine target?
Related
- Drug class: All Opioid agonist and local anesthetic drugs
- Target: All drugs targeting mu-opioid receptor
- Manufacturer: Brugmann University Hospital — full pipeline
- Therapeutic area: All drugs in Anesthesiology
- Indication: Drugs for Pain management during surgery
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing