NDAINJECTIONINJECTABLE
Approved
Jun 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
10
Data completeness
4/8 — Partial
EDEX (alprostadil) by R-Pharm US is prostaglandin receptor agonists [moa]. First approved in 1997.
Drug data last refreshed 2h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EDEX (alprostadil) is a prostaglandin receptor agonist administered by injection for erectile dysfunction. It works by dilating blood vessels and relaxing smooth muscle to increase penile blood flow. This small-molecule therapeutic addresses a well-established patient need in sexual medicine.
LOE Approaching
Moderate competitive pressure (30/100) and approaching loss of exclusivity signal a contracting team with focus on market defense and cost management rather than expansion.
Mechanism of Action
Prostaglandin Receptor Agonists
Pharmacologic Class:
Prostaglandin Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
A Study to Learn About the Study Medicine - Precedex in Children From Japan.
Started Oct 2023
111 enrolled
Sedation
Precedex Special Investigation (in Pediatric Patients)
Started Jul 2019
111 enrolled
Sedation
Study of OZURDEX® in the Treatment of Diabetic Macular Oedema (DME) in Australia - The AUSSIEDEX Study
Started Apr 2016
202 enrolled
Diabetic Macular Oedema
Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients
Started Sep 2010
373 enrolled
Intensive Care Unit
Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Started Oct 2009
89 enrolled
Endotracheal IntubationContinuous IV SedationICP Monitoring
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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.