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phenylephrine

Phase 1

Rhinitis | Small molecule | Other |Johnson & Johnson|Last Updated: Oct 6, 2011

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00762567Phenylephrine Pediatric Pharmacokinetic StudyPHASE1 COMPLETED 36 — — Sep 1, 2008Nov 1, 2008Oct 6, 20111 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetic Parameters
10, 20, 30, 45, and 60 minutes, and at 1.5, 2, 2.5, 3, and 3.5 hours after the dose. For children >6, an additional blood sample will be collected at 4.5 hours after dosing
Secondary Endpoints
For children 5 years and older and adolescents, the total amount of phenylephrine and its metabolites excreted, percent of the administered dose will be estimated from the urine samples along with the formation clearance of each metabolite.
24 hours
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.
throughout duration of the study + 2 days (+30 days for spontaneously reported SAEs)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALphenylephrine
Interventions
NameTypeDescription
phenylephrine HClDRUGA single dose of a liquid dosage form of phenylephrine HCl 2.5mg/5mL, using a weight-age dosing schedule
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Eligibility Criteria
Age Range2 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and female children and adolescents, ages 2 to \< 18 years, with a minimum weight of 24 pounds will be eligible to participate. In addition, each subject will be \> 5th percentile and \< 95th percentile for weight based on age and gender. * Subjects will have a body mass ...

Countries:United States
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Competitive Landscape -Allergic Rhinitis 4 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY1PHASE3LY3650150, Standard therapy for INCS
Polyrizon Ltd.PLRZ1NAUndisclosed
Regeneron Pharmaceuticals, Inc.REGN1 — Undisclosed
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