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Ketodex
Ketodex is a Small molecule drug developed by Giresun University. It is currently in Phase 2 development. Also known as: Ketamine-Dexmedetomidine.
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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 | Ketodex |
|---|---|
| Also known as | Ketamine-Dexmedetomidine |
| Sponsor | Giresun University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Comparison Between Two Drugs in Sedation of Upper GI Endoscopy
- Ketodex Versus Ketofol in Adolescent Gastrointestinal Endoscopy
- Comparison of the Hemodynamic Effects of Ketamine - Dexmedetomidine (Ketodex) Versus Propofol-ketamine Admixture (Ketofol) During Induction of Anesthesia in Elderly: A Randomized Comparative Study (NA)
- Ketodex Versus Opioid Based Anesthesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy. (NA)
- Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) in Ear and Nose Surgeries (NA)
- The Effect of Ketamine - Dexmedetomidine Admixture (Ketodex) on Hemodynamic Stability During Anesthesia Induction in Adults. (PHASE4)
- Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation (PHASE2, PHASE3)
- Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair Ketodex Versus Opioids in Cleft Palate Repaire (PHASE1)
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:
- Ketodex CI brief — competitive landscape report
- Ketodex updates RSS · CI watch RSS
- Giresun University portfolio CI
Frequently asked questions about Ketodex
What is Ketodex?
Who makes Ketodex?
Is Ketodex also known as anything else?
What development phase is Ketodex in?
Related
- Manufacturer: Giresun University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Ketamine-Dexmedetomidine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing