NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Sep 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
5/8 — Partial
Priority Review
ELUCIREM (gadopiclenol) by Guerbet is (macrocyclic non-ionic complex of gadolinium) that develops a magnetic moment when placed in a magnetic field. Approved for including term neonates, for use with magnetic resonance imaging (mri) to detect, visualize lesions with abnormal vascularity in: the central nervous system (brain and 7 more indications. First approved in 2022.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELUCIREM (gadopiclenol) is a macrocyclic non-ionic gadolinium contrast agent administered intravenously to enhance MRI imaging across the central nervous system, head, neck, thorax, abdomen, pelvis, and musculoskeletal system. It works by developing a magnetic moment in the MRI field that alters water proton relaxation rates, increasing tissue signal intensity to visualize lesions with abnormal vascularity. The product is approved for use in patients including term neonates.
Peak13.3 years to LOE
Product is at peak lifecycle stage with recent approval; commercial teams are building market presence in diagnostic imaging.
Mechanism of Action
(macrocyclic non-ionic complex of gadolinium) that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues.
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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.