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Brompheniramine

Phase 1

Allergic Reactions | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 23, 2020

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00894634Study Evaluating Brompheniramine Maleate Liquid in Children and AdolescentsPHASE1 COMPLETED 37Mar 21, 2009Apr 26, 2009Oct 23, 2020 -
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Study Endpoints
Primary Endpoints
Log transformed values of AUCL and Cmax
72 hours
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Brompheniramine maleateEXPERIMENTALBrompheniramine maleate oral solution 1 mg/5 mL, single dose
Interventions
NameTypeDescription
Brompheniramine maleateDRUG -
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Eligibility Criteria
Age Range2 Years — 17 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Males or females between 2 to less than 18 yrs of age with a minimum weight of 24 pounds and within the 5th and 95th percentiles in height and weight, and BMI based on age and gender 2. Symptomatic or asymptomatic children/adolescents as follows: * A prior diagnosis of al...

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