Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dexmedetomidine · 9 trials · 6 indications
Percentage of participants who did not require rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and State Behavioral Scale (SBS) (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation \[placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs\], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation \[removal of endotracheal tube\], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported.
Clinical Score Level of Sedation 0 Awake/Alert 1. Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2. Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3. Deeply sedated: Deep sleep, arousable only with significant physical stimulation. 4. Unarousable
Definition: * Hypotension: dosing start or dose increase of vasopressor drug or use of fluid bolus ≥500 mL within 1 hour resulting from SBP\<60mmHg, DBP\<40mmHg or ≥50% lower than baseline. * Hypertension: dosing start or dose increase of intravenous anti-hypertensive medication resulting from SBP\>160, DBP\>100 or. ≥50% higher than baseline. * Bradycardia: dosing start or dose increase of positive chronotropic medication or use of pacemaker resulting from heart rate \<40bpm or ≥50% lower than baseline.
Observer's Assessment of Alertness/Sedation Scale (OAA/S) score ≤4 (Responsiveness: Lethargic response to name spoken in normal tone; Speech: Mild slowing or thickening; Facial Expression: Mild relaxation; Eyes: Glazed or mild ptosis \[less than half the eye\])
Sedation levels (Ramsay Sedation Scale \[RSS\] score ≥2 \[Patient is cooperative, oriented and tranquil\])
Area under the plasma concentration-time curve of dexmedetomidine at 0 to Infinity hours
Maximum observed concentration of dexmedetomidine in plasma
Concentration of dexmedetomidine at steady state in plasma
Terminal elimination half-life of dexmedetomidine. Half-life is the time required for plasma concentration of the drug to decrease by 50%.
Observed time to reach maximum plasma concentration of dexmedetomidine, expressed in hours
Weight-Adjusted Plasma Clearance of dexmedetomidine after intravenous administration.
Clearance of dexmedetomidine after intravenous administration. Clearance is the rate at which the drug is removed from the plasma after the dose.
Volume of distribution of dexmedetomidine after intravenous administration. Volume of distribution measures how much the drug spreads through the body after the dose.
Weight-Adjusted Volume of distribution of dexmedetomidine after intravenous administration.
FLACC scale is a 5 category observational measure to assess pediatric pain on face, legs, activity, cry and consolability. Responses in each category are scored between 0 to 2 (0 = normal, relaxed to 2 = upset, rigid), for a maximum total score of 10.
The level of sedation will be assessed using the University of Michigan Sedation Scale (UMSS). Score 0 (awake/alert); Score 1 (sleepy/responds appropriately); Score 2 (somnolent/arouses to light stimuli); Score 3 (deep sleep/arouses to deeper physical stimuli); Score 4 (unarousable). The UMSS scores obtained just prior the loading dose (LD) and 5 and 10 minutes during LD; 0, 5, 10, 15, 30, and 60 minutes and thereafter every 4 hours of the maintenance infusion; within 5 minutes of obtaining each pharmacokinetic sample; within 5 minutes prior and after any midazolam rescue during dexmedetomidine infusion period.
Participants who received rescue medication midazolam for sedation and/or fentanyl for analgesic during study drug Infusion
| Arm | Type | Description |
|---|---|---|
| DA-9501 | EXPERIMENTAL | A single vial contains an injection solution with 2 mL of dexmedetomidine hydrochloride solution (100 µg/mL as dexmedetomidine) dissolved in physiological saline |
| Placebo | PLACEBO_COMPARATOR | Dexmedetomidine 0 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0 mcg/kg/hr Maintenance dose |
| Dexmedetomidine 0.067 mcg/kg | EXPERIMENTAL | Dexmedetomidine 0.4 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose |
| Dexmedetomidine 0.25 mcg/kg | EXPERIMENTAL | Dexmedetomidine 1.5 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose |
| Dexmedetomidine 0.5 mcg/kg | EXPERIMENTAL | Dexmedetomidine 3 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose |
| Dexmedetomidine 1.0 mcg/kg | EXPERIMENTAL | Dexmedetomidine 6 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose |
| Dexmedetomidine Low Dose | ACTIVE_COMPARATOR | - |
| Dexmedetomidine High dose | ACTIVE_COMPARATOR | - |
| Dexmedetomidine | EXPERIMENTAL | - |
| Dexmedetomidine 0.5 mcg/kg load | EXPERIMENTAL | - |
| Dexmedetomidine 1 mcg/kg load | EXPERIMENTAL | - |
| Placebo (PBO) | PLACEBO_COMPARATOR | Placebo load for 10 min and Placebo maintenance for 15 min |
| Dose level 1 | EXPERIMENTAL | Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion |
| Dose level 2 | EXPERIMENTAL | Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion |
| Dexmedetomidine 0.05 mcg/kg | EXPERIMENTAL | Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr. |
| Dexmedetomidine 0.1 mcg/kg | EXPERIMENTAL | Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr. |
| Dexmedetomidine 0.2 mcg/kg | EXPERIMENTAL | Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr. |
| Name | Type | Description |
|---|---|---|
| Dexmedetomidine hydrochloride | DRUG | * 45 weeks CGA to \< 6 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.4 µg/kg/h according to the pediatric subject's sedative state * 6 years old to \< 17 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.0 µg/kg/h according to the pediatric subject's sedative state |
| Placebo | DRUG | - |
| Dexmedetomidine | DRUG | Study drug titrated up or down to maintain target UMSS range. |
| Midazolam | DRUG | Rescue medication for sedation according to UMSS scores |
| Fentanyl | DRUG | Rescue medication for pain based on UMSS scores |
| Morphine | DRUG | Rescue medication for pain based on UMSS scores. |
| Dexmedetomidine HCL Injection | DRUG | - |
| Fentanyl/Morphine | DRUG | Per package insert, N-PASS scores and investigator discretion. |
Inclusion Criteria: 1. Subjects whose consent is obtained in writing prior to the clinical trial from a guardian after a full explanation. For subjects over 7 years old, it is desirable that an informed assent is also obtained from the pediatric subject him/herself when possible. 2. Subjects aged ≥...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan, Astra-Zeneca |
| Cardinal Health, Inc. | CAH | 1 | - | Undisclosed |
| Medtronic Plc | MDT | 1 | N/A | Undisclosed |
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.