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Dexmedetomidine IV
Dexmedetomidine IV is a Small molecule drug developed by Samsung Medical Center. It is currently in Phase 2 development. Also known as: Precedex.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Dexmedetomidine IV |
|---|---|
| Also known as | Precedex |
| Sponsor | Samsung Medical Center |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Effect of Lidocaine Infusion Versus Dexmedemidine Infusion on the Neurocognitive Function of Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography(ERCP): a Randomized, Controlled Trial. (NA)
- Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy (PHASE3)
- Using Lidocaine or Dexmedetomidine to Help Control Blood Pressure Spikes From a Tourniquet During Knee Surgery (PHASE2)
- The Effect of Dexmedetomidine Infusion Alone Versus the Combination of Dexmedetomidine and Melatonin on Reduction of Post-operative Delirium (POD) After Open Brain Surgeries (PHASE4)
- Comparison of Anesthetic Techniques for Early Recovery After Ankle Arthroscopy (NA)
- Safety and Efficacy of Dexmedetomidine in Controlling Hemodynamics During Resection of Active Thyroid Secreting Tumors (PHASE2, PHASE3)
- Attenuate the Stress Response in Laparoscopic Cholecystectomy (PHASE4)
- Transition From Acute to Chronic Opioid Use and Chronic Pain (EARLY_PHASE1)
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:
- Dexmedetomidine IV CI brief — competitive landscape report
- Dexmedetomidine IV updates RSS · CI watch RSS
- Samsung Medical Center portfolio CI
Frequently asked questions about Dexmedetomidine IV
What is Dexmedetomidine IV?
Who makes Dexmedetomidine IV?
Is Dexmedetomidine IV also known as anything else?
What development phase is Dexmedetomidine IV in?
Related
- Manufacturer: Samsung Medical Center — full pipeline
- Also known as: Precedex
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing