PHENYLEPHRINE HYDROCHLORIDE

Post-LOE

phenylephrine hydrochloride

Aspiro Therapeutics

ANDAINTRAVENOUSSOLUTION

Approved

Jun 2020

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

PHENYLEPHRINE HYDROCHLORIDE (phenylephrine hydrochloride) by Aspiro Therapeutics is α-1 adrenergic receptor agonist. Approved for clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. First approved in 2020.

Drug data last refreshed 18h ago

Mechanism of Action

α-1 adrenergic receptor agonist.

Indications (1)

clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia

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

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

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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.