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DA-9501

Phase 3

Sedation | Small molecule | Pain |Pfizer, Inc.|Last Updated: Jul 24, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment162
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01438931Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without IntubationPHASE3 COMPLETED 162 — — Jul 1, 2011Mar 1, 2012Jul 24, 201518 Japan
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Study Endpoints
Primary Endpoints
Incidence of patients who did not require rescue administration of propofol to achieve and maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 during the study drug administration
Pre-dose, every 5 ± 2 minutes during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Secondary Endpoints
Administration frequency and dosage of propofol required to achieve and maintain OAA/S score ≤4 during the study drug administration
After the start of study drug (20 ± 2 minutes), if the OAA/S score is 5.
Time to first rescue administration of propofol
≥15 minutes after the start of study drug infusion.
Incidence of patients who did not require rescue administration of fentanyl during the study drug administration
After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo groupPLACEBO_COMPARATORLoading infusion of Placebo over 10 minutes followed by maintenance infusion of Placebo
DA-9501 0.5 mcg/kg groupACTIVE_COMPARATORLoading infusion of Dexmedetomidine 3.0 mcg/kg/hr over 10 minutes followed by maintenance infusion of Dexmedetomidine 0.2-0.7 mcg/kg/hr
DA-9501 1.0 mcg/kg groupACTIVE_COMPARATORLoading infusion of Dexmedetomidine 6.0 mcg/kg/hr over 10 minutes followed by maintenance infusion of Dexmedetomidine 0.2-0.7 mcg/kg/hr
Interventions
NameTypeDescription
DA-9501DRUGDexmedetomidine hydrochloride variable dose
placeboDRUG -
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: 1. Patient has signed and dated the Informed Consent after the study had been fully explained. 2. Patient is male or female, at least 20 years of age when the Informed Consent is obtained. 3. American Society for Anesthesiologists (ASA) I to III Class at the preoperative diagnos...

Countries:Japan
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Competitive Landscape -Anesthesia and Sedation 4 trials
CompanyTickerTrialsLead PhaseDrugs
Masimo CorporationMASI1PHASE1Diprivan , Astra-Zeneca
Cardinal Health, Inc.CAH1 — Undisclosed
Medtronic PlcMDT1NAUndisclosed
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