PHENYLEPHRINE HYDROCHLORIDE

Peak

phenylephrine hydrochloride

NDAOPHTHALMICSOLUTION/DROPSPriority Review
Approved
Mar 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4

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…

Clinical Trials (4)

NCT01448057Phase 3Completed

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
NCT04534452Phase 3Completed

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
NCT01026961Phase 1/2Withdrawn

Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers

Started Sep 2010
0
Heart RateBlood PressureArrhythmias
NCT00976209Phase 3Completed

Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)

Started Aug 2009
331 enrolled
Vasomotor RhinitisSeasonal Allergic Rhinitis

Loss of Exclusivity

LOE Date
Nov 14, 2033
93 months away
Patent Expiry
Nov 14, 2033

Patent Records (1)

Patent #ExpiryTypeUse Code
8859623
Nov 14, 2033
U-1594