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 7h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELUCIREM (gadopiclenol) is a macrocyclic gadolinium-based contrast agent administered intravenously to enhance MRI imaging. It develops magnetic properties in the MRI field to increase signal intensity and visualize lesions with abnormal vascularity across the CNS, head, neck, thorax, abdomen, pelvis, and musculoskeletal system. The agent is approved for use in patients including term neonates.
Peak13.6 years to LOE
Early-stage peak lifecycle product with no documented competitive pressure, suggesting potential for market expansion and team growth.
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.