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dexamedatomidine
dexamedatomidine is a Small molecule drug developed by Armed Forces College of Medicine, Cairo, Egypt. It is currently in Phase 1 development.
Dexamedatomidine is used as a caudal analgesia in pediatric patients undergoing hypospadias surgery under general anesthesia. It is studied for its effectiveness and safety in reducing postoperative pain in children.
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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 | dexamedatomidine |
|---|---|
| Sponsor | Armed Forces College of Medicine, Cairo, Egypt |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Dexamedatomidine vs. Dexamethasone in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery (NA)
- Caudal Dexmedetomidine Analgesia in Pediatrics . (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:
- dexamedatomidine CI brief — competitive landscape report
- dexamedatomidine updates RSS · CI watch RSS
- Armed Forces College of Medicine, Cairo, Egypt portfolio CI
Frequently asked questions about dexamedatomidine
What is dexamedatomidine?
Who makes dexamedatomidine?
What development phase is dexamedatomidine in?
Related
- Manufacturer: Armed Forces College of Medicine, Cairo, Egypt — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing