NDAOPHTHALMICSOLUTION/DROPSPriority Review
Approved
Mar 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
PHENYLEPHRINE HYDROCHLORIDE (phenylephrine hydrochloride) by Aspiro Therapeutics is alpha-1 adrenergic receptor agonist used for dilation of the pupil due to its vasoconstrictor and mydriatic action. First approved in 2013.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Phenylephrine hydrochloride is an alpha-1 adrenergic receptor agonist administered as an ophthalmic solution for pupil dilation. It works by constricting ophthalmic blood vessels and contracting the radial muscle of the iris, producing potent vasoconstrictor and mydriatic effects. This small-molecule eye drop is used primarily in diagnostic and surgical ophthalmology procedures.
Peak7.4 years to LOE
Product is in peak commercial phase with established market presence; brand team likely optimized but finite in size given ophthalmic specialty segment.
Mechanism of Action
alpha-1 adrenergic receptor agonist used for dilation of the pupil due to its vasoconstrictor and mydriatic action. Phenylephrine possesses predominantly α-adrenergic effects. In the eye, phenylephrine acts locally as a potent vasoconstrictor and mydriatic, by constricting ophthalmic blood vessels…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
Started Jul 2013
341 enrolled
Upper Respiratory Tract InfectionNasal CongestionRhinorrhea+1 more
Study to Find Out Whether Participants With a History of Stuffy Nose Due to Allergic Reactions in the Nose Would Intend to Buy Drug Phenylephrine Hydrochloride Extended Release Tablets After Receiving it Once in This Study
Started May 2012
347 enrolled
Nasal Congestion Due to Allergic Rhinitis
Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers
Started Sep 2010
0Heart RateBlood PressureArrhythmias
Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)
Started Aug 2009
331 enrolled
Vasomotor RhinitisSeasonal Allergic Rhinitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.