NDAINJECTIONINJECTABLE
Approved
Nov 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
PROHANCE (gadoteridol) by Bracco is magnetic resonance contrast activity [moa]. Approved for paramagnetic contrast agent [epc]. First approved in 1992.
Drug data last refreshed 10h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROHANCE (gadoteridol) is a paramagnetic contrast agent administered via injection for use in magnetic resonance imaging (MRI) to enhance visualization of internal body structures. It works by altering the magnetic properties of water molecules in tissues, enabling better image contrast and diagnostic clarity. The drug has been a standard diagnostic tool since its 1992 approval.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), suggesting transition focus for the Bracco brand team toward lifecycle extensions or managed decline strategies.
Mechanism of Action
Magnetic Resonance Contrast Activity
Pharmacologic Class:
Paramagnetic Contrast Agent
Indications (1)
Clinical Trials (5)
Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs
Started Nov 2018
125 enrolled
Central Nervous System DiseasesCentral Nervous System Neoplasms
Evaluation of Gd Retention in Human Bone and Skin After MultiHance or ProHance Administration Compared With Control
Started Oct 2014
28 enrolled
Gadolinium Retention
Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain
Started Aug 2012
229 enrolled
Brain Disease
Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease
Started Feb 2008
172 enrolled
Renal Insufficiency
SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
Started Aug 2007
165 enrolled
Brain Metastases
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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.