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Fentanyl, Dexmedetomidine
Fentanyl, Dexmedetomidine is a Opioid agonist + alpha-2 adrenergic agonist combination Small molecule drug developed by University of Saskatchewan. It is currently in Phase 3 development for Sedation and analgesia in perioperative or critical care settings (Phase 3 investigational). Also known as: Opioid sparing pre-intubation medications.
This combination uses fentanyl (an opioid agonist) for analgesia and dexmedetomidine (an alpha-2 adrenergic agonist) for sedation and anxiolysis.
This combination uses fentanyl (an opioid agonist) for analgesia and dexmedetomidine (an alpha-2 adrenergic agonist) for sedation and anxiolysis. Used for Sedation and analgesia in perioperative or critical care settings (Phase 3 investigational).
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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 | Fentanyl, Dexmedetomidine |
|---|---|
| Also known as | Opioid sparing pre-intubation medications |
| Sponsor | University of Saskatchewan |
| Drug class | Opioid agonist + alpha-2 adrenergic agonist combination |
| Target | Mu-opioid receptor; alpha-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Anesthesia, Pain Management, Sedation |
| Phase | Phase 3 |
Mechanism of action
Fentanyl binds to mu-opioid receptors in the central and peripheral nervous system to produce analgesia and euphoria. Dexmedetomidine selectively binds alpha-2 adrenergic receptors in the brain and spinal cord to produce sedation, anxiolysis, and analgesia without respiratory depression. Together, they provide multimodal anesthesia/analgesia with potentially reduced opioid requirements.
Approved indications
- Sedation and analgesia in perioperative or critical care settings (Phase 3 investigational)
Common side effects
- Respiratory depression
- Hypotension
- Bradycardia
- Sedation/drowsiness
- Nausea
Key clinical trials
- The Relationship Between Opioid-Free Anesthesia and Postoperative Agitation-Delirium and Quality of Recovery in Pediatric Ear, Nose, and Throat Cases Monitored With Perioperative Bispectral Index
- Cardiac Index and General Anesthesia Without Opioid. (PHASE2, PHASE3)
- Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy (PHASE3)
- Effect of Dexmedetomidine Dosage on Postoperative Delirium in Geriatric Orthopedic Surgery (PHASE2)
- Attenuate the Stress Response in Laparoscopic Cholecystectomy (PHASE4)
- Transition From Acute to Chronic Opioid Use and Chronic Pain (EARLY_PHASE1)
- Comparison of C-Reactive Protein Levels in Traumatic Brain Injury Patients Undergoing Craniotomy With and Without Dexmedetomidine (PHASE4)
- General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients (NA)
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:
- Fentanyl, Dexmedetomidine CI brief — competitive landscape report
- Fentanyl, Dexmedetomidine updates RSS · CI watch RSS
- University of Saskatchewan portfolio CI
Frequently asked questions about Fentanyl, Dexmedetomidine
What is Fentanyl, Dexmedetomidine?
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Is Fentanyl, Dexmedetomidine also known as anything else?
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Related
- Drug class: All Opioid agonist + alpha-2 adrenergic agonist combination drugs
- Target: All drugs targeting Mu-opioid receptor; alpha-2 adrenergic receptor
- Manufacturer: University of Saskatchewan — full pipeline
- Therapeutic area: All drugs in Anesthesia, Pain Management, Sedation
- Indication: Drugs for Sedation and analgesia in perioperative or critical care settings (Phase 3 investigational)
- Also known as: Opioid sparing pre-intubation medications
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing