ELUCIREM

Peak

gadopiclenol

Guerbet
NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Sep 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10

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.

Indications (10)

older for use with magnetic resonance imaging (MRI) to detectvisualize lesions with abnormal vascularity in: the central nervous system (brainspineassociated tissues)the body (headneckthoraxabdomenpelvismusculoskeletal system)

Clinical Trials (5)

NCT07348640Phase 3Not Yet Recruiting

Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease

Started Feb 2026
315 enrolled
Steno-occlusive Disease
NCT06127810N/AWithdrawn

MRI Gadopiclenol Enhanced Imaging of CNS Tumors

Started Dec 2024
0
Image
NCT06596616N/AEnrolling By Invitation

Gadopiclenol vs Gadoxetate MRI for Liver Lesions

Started Jul 2024
75 enrolled
Liver Lesion
NCT06226129Phase 4Recruiting

Gadopiclenol in Contrast Enhanced MRI of the Prostate

Started Feb 2024
150 enrolled
Prostate Cancer
NCT06057168Phase 3Completed

Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas

Started Sep 2023
138 enrolled
Brain Tumor, PrimaryBrain Tumor, Recurrent

Loss of Exclusivity

LOE Date
Jan 17, 2040
168 months away
Patent Expiry
Jan 17, 2040
Exclusivity Expiry
Sep 21, 2027

Patent Records (4)

Patent #ExpiryTypeUse Code
8114863
Sep 19, 2028
Substance
—
10973934
Aug 6, 2039
Substance
—
11590246
Jan 17, 2040
Product
—
12064487
Jan 17, 2040
U-4424
Company
Guerbet
Guerbet
France - Villepinte
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers