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phenylephrine

Phase 4FDA approved

Rhinitis | Small molecule | Respiratory |Johnson & Johnson|Trials Updated: Oct 6, 2011

phenylephrine development status

FDA approval on record Mar 21, 2013
Approval holderParagon Bioteck
ApplicationNDA203510
Highest phase Phase 4 run by GlaxoSmithKline (NCT01332578)
Phase scored for JNJPhase 1
Registered trials 6 across 6 sponsors since Jan 2006

Label indication Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil (1 ). FDA label

phenylephrine target and mechanism

Molecular targetADRA1A, ADRA1D, ADRA1B
Target classAgonist
ModalitySmall molecule

Also known as phenylephrine HCl, Children's Sudafed PE Nasal Decongestant Liquid

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

phenylephrine clinical trials

phenylephrine · 1 trial · 1 indication

Phase 1 1
NCT00762567Phenylephrine Pediatric Pharmacokinetic StudyRhinitis
COMPLETED36 Analytics
PHASE1COMPLETED
Phenylephrine Pediatric Pharmacokinetic Study
RhinitisUnlock trial analytics

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 to 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 8 trials (matched to "Rhinitis")

Top 1 of 3 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY1PHASE3LY3650150
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Frequently asked questions about phenylephrine

What is phenylephrine used for?

Phenylephrine is studied for rhinitis, a condition involving nasal inflammation and congestion. It is a small molecule developed by Johnson & Johnson (ticker JNJ). The clinical program in rhinitis has focused on pediatric pharmacokinetics rather than large efficacy trials.

What does phenylephrine target?

Phenylephrine targets the alpha-1 adrenergic receptors ADRA1A, ADRA1B, and ADRA1D, where it acts as an agonist. By activating these receptors it produces vasoconstriction, which is the pharmacological basis for its use in nasal congestion associated with rhinitis.

Who makes phenylephrine?

Johnson & Johnson, which trades under the ticker JNJ, is the developer associated with phenylephrine. The company is linked to the clinical development program for this small molecule in rhinitis.

What phase is phenylephrine in?

Phenylephrine is in Phase 1 clinical development for rhinitis. The program has one completed Phase 1 trial, and no active trials are currently listed. It is an investigational asset in this development context rather than a newly approved product.

What clinical trials is phenylephrine in?

Phenylephrine has been studied in NCT00762567, a completed Phase 1 pediatric pharmacokinetic study in rhinitis. The trial enrolled 36 participants in the United States, included ages 2 years and older, and was uncontrolled, with no randomization or blinding.

Is phenylephrine the same as phenylephrine HCl?

Yes, phenylephrine HCl is another name for phenylephrine. The HCl designation refers to the hydrochloride salt form of the same small molecule, so searches for either name refer to the same active ingredient and the same clinical development program.