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Rocuronium bromide

Phase 3

Muscle Relaxation | Small molecule | Other |Merck & Company, Inc.|Last Updated: May 12, 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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00984633Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)PHASE3 COMPLETED 40Jun 1, 2003Dec 1, 2003May 12, 2015 -
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Study Endpoints
Primary Endpoints
Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation
Time from intubating dose to bolus maintenance dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
0.6 mg/kg intubation dose + sevofluraneEXPERIMENTAL -
0.9 mg/kg intubation dose + sevofluraneEXPERIMENTAL -
0.6 mg/kg intubation dose + propofolEXPERIMENTAL -
0.9 mg/kg intubation dose + propofolEXPERIMENTAL -
Interventions
NameTypeDescription
Rocuronium bromide (Org 9426)DRUG0.6 mg/kg injection intubation dose
SevofluraneDRUG0.5-2.0% intravenous maintenance anesthesia
PropofolDRUG4-10 mg/kg/hr maintenance anesthesia
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Eligibility Criteria
Age Range20 Years — 64 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects at least 20 but under 65 years of age. * Subjects of asa class 1, 2 or 3 for general elective surgery. * Subjects who are not considered to be pregnant. * Subjects scheduled for elective surgery under sevoflurane or propofol anesthesia, with anticipated duration of su...

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