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Dexmedetomine
Dexmedetomine is a Small molecule drug developed by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Dexmedetomine |
|---|---|
| Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- The Effects of Dexmedetomidine on Cerebral Autoregulation and Cerebral Oxygenation in Subarachnoid Haemorrhage Patients (Phase 1)
- Dexmedetomidine Comme Adjuvant à la rachianesthésie Lors de césariennes électives : Une étude Pilote (Phase 3)
- The Effect of Dexmedetomine Premedication on the Bispectral Index Values Using Sedation With Propofol During Spinal Anesthesia on Geriatric Chronic Renal Failure Patients Undergoing Hip Fracture Surge (Phase 3)
- A Comparative Study Between the Use of Dexmedetomidine Versus Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Post-operative Pain Relief in Patients (Phase 4)
- Assessing the Efficacy of Dexmedetomidine in Alleviating Agitation for Exacerbated COPD Patients Who Are Treated for Psychosis Requiring Non- Invasive Ventilation (N/A)
- A Pharmacokinetic Study of Dexmedetomine in Infants (Phase 1)
- Intranasal Remimazolam for Premedication in Pediatric Patients: a Double-blinded Randomized Clinical Trial (Phase 4)
- Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations (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:
- Dexmedetomine CI brief — competitive landscape report
- Dexmedetomine updates RSS · CI watch RSS
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) portfolio CI
Frequently asked questions about Dexmedetomine
What is Dexmedetomine?
Who makes Dexmedetomine?
What development phase is Dexmedetomine in?
Related
- Manufacturer: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing