Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dexmedetomidine, midazolam; fentanyl · 1 trial · 1 indication
Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t) for Dexmedetomidine
Area under the concentration-time curve from time zero to the time infinity (AUC0-∞) for Dexmedetomidine
Observed peak plasma concentration (Cmax) for Dexmedetomidine
Terminal elimination half-life (t1/2) for Dexmedetomidine
Plasma concentration at steady state (Css) for Dexmedetomidine
Volume of steady state distribution (Vss) for Dexmedetomidine
Clearance (CL) for Dexmedetomidine
RSS Score range from 1 to 6: 1. Patient is anxious and agitated or restless, or both. 2. Patient is cooperative, orientated and tranquil. 3. Patient responds to command only. 4. Patient exhibits brisk response to light glabellar (between the eyebrows) tap or loud auditory stimulus. 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus. 6. Patient exhibits no response to stimulus.
Number of subjects who received rescue medication for Sedation (Midazolam) and analgesics (Fentanyl) while intubated during Treatment Period
| Arm | Type | Description |
|---|---|---|
| Group 1 | OTHER | Dose level 1 |
| Group 2 | OTHER | Dose level 2 |
| Group 3 | OTHER | Dose level 3 |
| Group 4 | OTHER | Dose level 4 |
| Name | Type | Description |
|---|---|---|
| Dexmedetomidine, midazolam; fentanyl | DRUG | Dexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label |
Inclusion Criteria: * Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require a minimum of 6 hours of continuous intravenous sedation. * Age: subjects must fit into one of the following age ranges at screening: * ≥2 years old through...
Dexmedetomidine is an investigational small molecule being studied for use in awake fiberoptic intubation, sedation, ICU sedation, anesthesia, and in intubated and mechanically ventilated pediatric subjects. It is being developed by Pfizer, Inc. (PFE) and is currently in Phase 3 clinical development.
Dexmedetomidine is a small molecule that acts as a selective alpha-2 adrenergic receptor agonist. By binding to these receptors, it produces sedative, analgesic, and anxiolytic effects, which are being studied for applications in sedation and anesthesia across various patient populations.
Dexmedetomidine is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy in sedation and anesthesia indications.
Dexmedetomidine is in Phase 3 clinical development. While it has completed Phase 2 trials in pediatric sedation and intubated subjects, it remains investigational and has not been approved by regulatory authorities. The drug is still undergoing clinical evaluation to establish its safety and efficacy profile.
Dexmedetomidine has completed five clinical trials, including Phase 2 studies (NCT00652028, NCT01159262, NCT01378988) and a Phase 3 study (NCT02757625). These trials evaluated the drug in pediatric subjects for sedation, ICU sedation, and intubated and mechanically ventilated conditions across the United States, Guatemala, and Japan.
Yes, Dexmedetomidine is the same as DA-9501. The Phase 3 clinical trial NCT02757625, titled 'Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit,' evaluates Dexmedetomidine for ICU sedation in pediatric subjects in Japan.