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Sedation by ketamine
Sedation by ketamine is a Anesthetic Small molecule drug developed by University Hospital, Montpellier. It is currently in Phase 3 development for Sedation for short-term procedures, Anesthesia for surgical procedures.
Ketamine acts as an NMDA receptor antagonist, blocking the action of glutamate at the NMDA receptor.
Ketamine is used as a sedation intervention in various medical procedures, including conscious sedation, pediatric flexible bronchoscopy, and monitored anesthesia care for conditions such as chronic subdural hematoma. According to ClinicalTrials.gov, ketamine has also been studied as a potential treatment for major depressive disorder and burns.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Sedation by ketamine |
|---|---|
| Sponsor | University Hospital, Montpellier |
| Drug class | Anesthetic |
| Target | NMDA receptor |
| Modality | Small molecule |
| Therapeutic area | Anesthesiology |
| Phase | Phase 3 |
Mechanism of action
This blockade results in a decrease in excitatory neurotransmission, leading to sedation and analgesia. The exact mechanism of ketamine's anesthetic effects is not fully understood, but it is thought to involve a combination of NMDA receptor antagonism and other mechanisms, such as inhibition of AMPA and kainate receptors.
Approved indications
- Sedation for short-term procedures
- Anesthesia for surgical procedures
Common side effects
- Dissociation
- Hallucinations
- Nausea and vomiting
- Increased heart rate and blood pressure
Key clinical trials
- Prospective IR-led Sedation Feasibility (PHASE1, PHASE2)
- An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyperactive Delirium (PHASE4)
- General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients (NA)
- Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches (PHASE3)
- Comparison of Peri-intubation Oxygenation Values and Complications in Patients Intubated With the Delayed Versus Rapid Sequence Intubation Protocols (NA)
- Effect of Intravenous Dexmedetomidine and Ketamine on Post-Operative Analgesia (PHASE3)
- Ketamine and Propofol NeuroImaging (EARLY_PHASE1)
- Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia (PHASE4)
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:
- Sedation by ketamine CI brief — competitive landscape report
- Sedation by ketamine updates RSS · CI watch RSS
- University Hospital, Montpellier portfolio CI
Frequently asked questions about Sedation by ketamine
What is Sedation by ketamine?
How does Sedation by ketamine work?
What is Sedation by ketamine used for?
Who makes Sedation by ketamine?
What drug class is Sedation by ketamine in?
What development phase is Sedation by ketamine in?
What are the side effects of Sedation by ketamine?
What does Sedation by ketamine target?
Related
- Drug class: All Anesthetic drugs
- Target: All drugs targeting NMDA receptor
- Manufacturer: University Hospital, Montpellier — full pipeline
- Therapeutic area: All drugs in Anesthesiology
- Indication: Drugs for Sedation for short-term procedures
- Indication: Drugs for Anesthesia for surgical procedures
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing