Last reviewed · How we verify
dexamedetomidine
dexamedetomidine is a Small molecule drug developed by Assiut University. It is currently in Phase 2 development. Also known as: precedex, dexamedetomidine Hcl injection.
-
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 | dexamedetomidine |
|---|---|
| Also known as | precedex, dexamedetomidine Hcl injection |
| Sponsor | Assiut University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- To Compare Post-op Analgesic Effectiveness of Ropivicaine+Dexamethasone and Ropivacane+Dexmetomidine in TAP Block in Stoma Reversal Under GA in Terms of Duration of Analgesia. (PHASE2, PHASE3)
- Comparison Between Erector Spinae Plane Block Versus Serratus Anterior Plane Block Regarding Analgesia Post Modified Radical Mastectomy (PHASE3)
- Comparison Between Fentanyl and Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block for Postoperative Analgesia After Knee Surgeries (NA)
- Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia. (NA)
- Intraperitoneal Analgesia in Pediatric Laparoscopy (PHASE2)
- Intra-articular Dexmedetomidine Versus Neostigmine After Knee Arthroscopy (a Comparative Study) (PHASE2, PHASE3)
- Analgesia in Knee Arthroscopic Surgery (PHASE2)
- The Effect of Dexamedetomidine for Interscalene Brachial Plexus Block on Plasma Biomarkers After Rotator Cuff Repair (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:
- dexamedetomidine CI brief — competitive landscape report
- dexamedetomidine updates RSS · CI watch RSS
- Assiut University portfolio CI
Frequently asked questions about dexamedetomidine
What is dexamedetomidine?
Who makes dexamedetomidine?
Is dexamedetomidine also known as anything else?
What development phase is dexamedetomidine in?
Related
- Manufacturer: Assiut University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: precedex, dexamedetomidine Hcl injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing