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Dexmetomidine
Dexmetomidine is a Small molecule drug developed by Jincheng General Hospital. 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 | Dexmetomidine |
|---|---|
| Sponsor | Jincheng General Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Optimal Dose of Dexmedetomidine Sedation Following Spinal Anesthesia: Postpartum Versus Nonpregnant Women (Phase 4)
- INTRAVENOUS Versus EPIDURAL DEXMEDETOMIDINE for ANALGESIA in NORMAL VAGINAL DELIVERY: A RANDOMIZED CONTROLED STUDY (Phase 4)
- EEG Characteristics of Different Sedation Depths in Patients With Supratentorial Glioma in Frontal Lobe (N/A)
- Comparison of Dexmetomidine's Efficacy as an Adjuvant to Intrathecal Levobupivacaine and Intravenous Administration Additionally to Spinal Anaesthesia, In Total Knee Arthroplasty (Phase 4)
- Effects of Dexmetomidine and Remifentanil Used for Controlled Hypotension in Septorhinoplasty Surgery on Cardiac Electrophysiology: Prospective Randomized Study (NA)
- Efficacy of Adding Dexmedetomidine to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Prospective Randomized Trial (Phase 1)
- Effects of Dexmedetomidine Addition to Bupivacaine on the Quality of Fascia Iliaca Compartment Block (FICB) in Children Undergoing Femur Fracture Surgery (Phase 1)
- Evaluating the Effect of Topical Lidocaine Spray Versus Dexmedetomidine Spray on Suppression of Stress Response to Laryngoscopy and Endotracheal Intubation: a Randomized Controlled Study (Phase 4)
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:
- Dexmetomidine CI brief — competitive landscape report
- Dexmetomidine updates RSS · CI watch RSS
- Jincheng General Hospital portfolio CI
Frequently asked questions about Dexmetomidine
What is Dexmetomidine?
Who makes Dexmetomidine?
What development phase is Dexmetomidine in?
Related
- Manufacturer: Jincheng General Hospital — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing