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Remimazolam Tosilate

Phase 3

Sedation | Small molecule | Pain |Co-Diagnostics, Inc.|Last Updated: Dec 19, 2018

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-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment388
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03779061Study of Remimazolam Tosilate in Patients Undergoing ColonoscopyPHASE3 COMPLETED 388Jun 28, 2018Sep 28, 2018Dec 19, 20181 China
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Study Endpoints
Primary Endpoints
rate of successful sedation
approximately 3 hours

successful sedation rate as measured by the proportion of subjects who experienced successful sedation during colonoscopy

Secondary Endpoints
Sedation induction time
approximately 3 hours
Sedation recovery time
approximately 3 hours
rate of hypotension
approximately 3 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Remimazolam TosilateEXPERIMENTAL -
PropofolACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Remimazolam TosilateDRUGInitial dose plus supplemental doses as necessary
PropofolDRUGInitial dose plus supplemental doses as necessary
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * subjects aged 18-65 years; * intending to undergo colonoscopy; * ASA( American Society of Anesthesiologists) I or II; * 18 kg/m²\<BMI(Body Mass Index)\<30 kg/m²; * the operation time of gastroscopy is not more than 30 min; * Signed informed consent. Exclusion Criteria: Patie...

Countries:China
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Competitive Landscape -Anesthesia and Sedation 4 trials
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