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DA-9501

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment162

FDA Designations

No designations recorded

Clinical trial landscape

DA-9501 · 1 trial · 1 indication

Phase 3 1
NCT01438931Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without IntubationSedation
COMPLETED162 Analytics
PHASE3COMPLETED
Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation
Sedation
NCT01438931162
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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 to 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 (matched to "Sedation")

CompanyTickerTrialsLead PhaseDrugs
Masimo CorporationMASI1PHASE1Diprivan, Astra-Zeneca
Cardinal Health, Inc.CAH1 - Undisclosed
Medtronic PlcMDT1N/AUndisclosed
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Frequently asked questions about DA-9501

What is DA-9501 used for?

DA-9501 is an investigational small molecule being developed for sedation. It is intended for use during surgery or medical procedures without intubation, as studied in a Phase 3 clinical trial. The drug is not yet approved and remains in clinical development.

Who makes DA-9501?

DA-9501 is being developed by Pfizer, Inc., which is publicly traded under the ticker PFE. The company is conducting clinical research on this investigational drug for sedation purposes.

What phase is DA-9501 in?

DA-9501 is in Phase 3 clinical development. A Phase 3 trial has been completed, but the drug is still investigational and has not been approved by regulatory authorities. Its safety and efficacy continue to be evaluated.

What clinical trials is DA-9501 in?

DA-9501 has one completed Phase 3 trial, NCT01438931, which investigated its efficacy and safety in sedation during surgery or medical procedures without intubation. The trial enrolled 162 participants in Japan and was randomized, double-blind, and placebo-controlled.

Is DA-9501 FDA approved?

DA-9501 is not FDA approved. It is an investigational drug that has completed a Phase 3 clinical trial, but approval status has not been established. The drug remains in clinical development and has not been authorized for commercial use.