NDAOPHTHALMICSOLUTION/DROPS1 Generic Approved
Approved
Jan 2015
Lifecycle
Peak
Competitive Pressure
45/100
Clinical Trials
4
Data completeness
2/8 — Basic
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Phenylephrine hydrochloride is a selective alpha-1 adrenergic agonist delivered as an ophthalmic solution for mydriasis (pupil dilation) in diagnostic and therapeutic eye procedures. It works by stimulating alpha-1 receptors on the dilator muscle of the iris, causing pupil constriction and vasodilation. This small-molecule decongestant has established utility in ophthalmology for pre- and intra-operative applications.
Peak
Phenylephrine is at peak lifecycle maturity in the ophthalmic space with moderate competitive pressure (45%), indicating stable demand and established team structures with limited expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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.