Gadopiclenol

Overview

Gadopiclenol is a gadolinium-based contrast agent (GBCA) based on a pyclen macrocyclic structure. It is indicated for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system and the body. In 2006, the use of GBCAs was associated with the development of nephrogenic systemic fibrosis (NSF), a rare disorder characterized by the thickening and hardening of skin and subcutaneous tissues. However, studies revealed that NSF was associated with linear GBCAs, not macrocyclic GBCAs, such as gadopiclenol. Gadopiclenol has high kinetic stability and a high r1 relaxivity, allowing it to be used at lower doses than classic extracellular GBCAs. In September 2022, the use of gadopiclenol was approved by the FDA. The product label includes a black box warning regarding the increased risk for NSF among patients with impaired elimination of the drugs.

Indication

Gadopiclenol is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Randomized Comparison of Contrast Agents Gadopiclenol and Gadobutrol in the Workup of Incidental Renal and Adrenal Findings	2025/06/27	NCT07040865	Not Applicable	Not yet recruiting	Insel Gruppe AG, University Hospital Bern
Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)	2025/02/26	NCT06846853	Phase 4	Recruiting	UConn Health
Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics	2024/05/09	NCT06406517	Phase 3	Not yet recruiting	University of California, San Diego
Gadopiclenol in Contrast Enhanced MRI of the Prostate	2024/01/26	NCT06226129	Phase 4	Not yet recruiting	University of Massachusetts, Worcester
MRI Gadopiclenol Enhanced Imaging of CNS Tumors	2023/11/13	NCT06127810	N/A	Withdrawn	Medical University of South Carolina
Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas	2023/09/28	NCT06057168	Phase 3	Completed	Guerbet
Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children	2023/08/24	NCT06010173	Phase 3	Completed	Guerbet
High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment	2023/07/20	NCT05954559	Phase 4	Recruiting	Johns Hopkins University
Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age	2022/10/21	NCT05590884	Phase 2	Completed	Guerbet
Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers	2021/05/28	NCT04906005	Phase 1	Completed	Guerbet

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Vueway	BRACCO DIAGNOSTICS INC	0270-7030	INTRAVENOUS	485.1 mg in 1 mL	9/28/2022
Vueway	BRACCO DIAGNOSTICS INC	0270-7015	INTRAVENOUS	485.1 mg in 1 mL	9/28/2022
ELUCIREM	Guerbet LLC	67684-4231	INTRAVENOUS	485.1 mg in 1 mL	10/26/2022
ELUCIREM	Guerbet LLC	67684-4250	INTRAVENOUS	485.1 mg in 1 mL	10/26/2022
ELUCIREM	Guerbet LLC	67684-4242	INTRAVENOUS	485.1 mg in 1 mL	10/26/2022
Vueway	BRACCO DIAGNOSTICS INC	0270-7035	INTRAVENOUS	485.1 mg in 1 mL	9/28/2022
Vueway	BRACCO DIAGNOSTICS INC	0270-7025	INTRAVENOUS	485.1 mg in 1 mL	9/28/2022
ELUCIREM	Guerbet LLC	67684-4232	INTRAVENOUS	485.1 mg in 1 mL	10/26/2022
ELUCIREM	Guerbet LLC	67684-4230	INTRAVENOUS	485.1 mg in 1 mL	10/26/2022
ELUCIREM	Guerbet LLC	67684-4233	INTRAVENOUS	485.1 mg in 1 mL	10/26/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Vueway	Bracco Imaging S.p.A.,Via Egidio Folli 50,20134 Milan,ITALY	Authorised	12/7/2023
Elucirem	Guerbet,15 rue des Vanesses,93420 Villepinte,FRANCE	Authorised	12/7/2023

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
VUEWAY gadopiclenol 4.85 mg/10 mL injection solution vial	444266	Guerbet Australia Pty Ltd	Medicine	A	4/22/2025
ELUCIREM gadopiclenol 4.85 mg/10 mL injection solution prefilled syringe	444271	Guerbet Australia Pty Ltd	Medicine	A	4/22/2025
ELUCIREM gadopiclenol 7.28 mg/15 mL injection solution prefilled syringe	444290	Guerbet Australia Pty Ltd	Medicine	A	4/22/2025
ELUCIREM gadopiclenol 24.26 mg/50 mL injection solution vial	444262	Guerbet Australia Pty Ltd	Medicine	A	4/22/2025
ELUCIREM gadopiclenol 48.1 mg/100 mL injection solution vial	444263	Guerbet Australia Pty Ltd	Medicine	A	4/22/2025
ELUCIREM gadopiclenol 3.64 mg/7.5 mL injection solution vial	444259	Guerbet Australia Pty Ltd	Medicine	A	4/22/2025
ELUCIREM gadopiclenol 14.56 mg/30 mL injection solution vial	444261	Guerbet Australia Pty Ltd	Medicine	A	4/22/2025
VUEWAY gadopiclenol 3.64 mg/7.5 mL injection solution vial	444265	Guerbet Australia Pty Ltd	Medicine	A	4/22/2025
VUEWAY gadopiclenol 1.46 mg/3 mL injection solution vial	444264	Guerbet Australia Pty Ltd	Medicine	A	4/22/2025
VUEWAY gadopiclenol 7.28 mg/ 15 mL injection solution vial	444292	Guerbet Australia Pty Ltd	Medicine	A	4/22/2025

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ELUCIREM 0,5 MMOL/ML SOLUCION INYECTABLE	Guerbet	1231772002	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
VUEWAY 0,5 MMOL/ML SOLUCION INYECTABLE	Bracco Imaging S.P.A.	1231773001	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
ELUCIREM 0,5 MMOL/ML SOLUCION INYECTABLE	Guerbet	1231772011	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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