Last reviewed · How we verify
dexmedetomedine
dexmedetomedine is a Small molecule drug developed by Mansoura University. It is currently in Phase 1 development.
-
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 | dexmedetomedine |
|---|---|
| Sponsor | Mansoura University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- To Evaluate Effect of Nebulized Dexmedetomedine Upon Blunting Autonomic Response of Laeyngoscopy and Intubation in Patients Undergoing Elective Intubation (NA)
- COMPARISON OF INTRAVENOUS DEXMEDETOMEDINE AND TRAMADOL FOR POST OPERATIVE SHIVERING AFTER SPINAL ANESTHESIA FOR CAESAREAN SECTION (PHASE4)
- COMPARISON OF MEAN DURATION OF POST OPERATIVE ANALGESIA FOLLOWING ADDITION OF DEXMEDETOMIDINE TO ROPIVACAINE VERSUS PLAIN ROPIVACAINE ON ULTRASOUND GUIDED RECTUS SHEATH BLOCK (NA)
- The Prolonging Effect of Dexmedetomidine on Spinal Anesthesia Through Different Routes if Administrations (PHASE4)
- Comparing Dexamethasone With Dexmedetomidine as Additives to Bupivacaine in Adductor Canal Block for Knee Arthroscopy. (NA)
- Dexamethasone Versus Demedetomidine Addition for Adductor Canal Block (NA)
- Dexmedetomidine vs Fentanyl in Controlling Labor Pain (NA)
- Dexmedetomedine and Ketamine in Erector Spinae Block for Postoperative Analgesia Following Mastectomy. (PHASE2, PHASE3)
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:
- dexmedetomedine CI brief — competitive landscape report
- dexmedetomedine updates RSS · CI watch RSS
- Mansoura University portfolio CI
Frequently asked questions about dexmedetomedine
What is dexmedetomedine?
Who makes dexmedetomedine?
What development phase is dexmedetomedine in?
Related
- Manufacturer: Mansoura University — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing