NDAINTRAVENOUSSOLUTION
Approved
Oct 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
BIORPHEN (phenylephrine hydrochloride) by Dr. Reddy's Laboratories is α-1 adrenergic receptor agonist. First approved in 2019.
Drug data last refreshed 6h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIORPHEN is an intravenous solution of phenylephrine hydrochloride, an α-1 adrenergic receptor agonist approved by the FDA in October 2019. It is indicated for acute hypotension management in critical care and perioperative settings. The drug works by stimulating α-1 adrenergic receptors to induce vasoconstriction and increase blood pressure.
Peak
Product is in peak commercial stage with established hospital formulary presence; team likely focused on market penetration and cost management rather than growth expansion.
Mechanism of Action
α-1 adrenergic receptor agonist.
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.