Gadopiclenol

Summary

Gadopiclenol (CHEMBL4297634) is an approved small molecule (ATC V08CA12); indicated across 4 conditions including brain neoplasm and congenital heart disease.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: V08CA12
• Indications: 4 conditions
• Clinical trials: 20

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297634
Name	Gadopiclenol
Type	Small molecule
Max phase	4
ATC	V08CA12

Also known as: Elucirem, Gadopiclenol, P-03277, P03277, Vueway, GADOPICLENOL

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

4 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
brain neoplasm	3	MONDO:0021211	EFO:0003833
congenital heart disease	3	MONDO:0005453	EFO:0005207
central nervous system disorder	2	MONDO:0002602	EFO:0009386

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 20.

Phase distribution

Phase	Trials
PHASE3	6
PHASE4	4
PHASE2	3
PHASE1	3
Not specified	3
PHASE1/PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05954559	PHASE4	RECRUITING	High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
NCT06226129	PHASE4	RECRUITING	Gadopiclenol in Contrast Enhanced MRI of the Prostate
NCT06846853	PHASE4	RECRUITING	Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)
NCT07040865	PHASE4	RECRUITING	Randomized Comparison of Contrast Agents Gadopiclenol and Gadobutrol in the Workup of Incidental Renal and Adrenal Findings
NCT07348640	PHASE3	NOT_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
NCT03986138	PHASE3	COMPLETED	Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
NCT03996447	PHASE3	COMPLETED	Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
NCT06010173	PHASE3	COMPLETED	Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children
NCT06057168	PHASE3	COMPLETED	Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas
NCT06406517	PHASE3	UNKNOWN	Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics
NCT02633501	PHASE2	COMPLETED	P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
NCT03603106	PHASE1/PHASE2	COMPLETED	Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions
NCT03749252	PHASE2	COMPLETED	Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI
NCT05590884	PHASE2	COMPLETED	Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age
NCT03657264	PHASE1	COMPLETED	Cardiac Safety Evaluation of P03277
NCT03657784	PHASE1	COMPLETED	Pharmacokinetics, Dialysability and Safety of P03277 in Healthy Volunteers and in Patients With Impaired Renal Function
NCT04906005	PHASE1	COMPLETED	Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers
NCT06596616	Not specified	ENROLLING_BY_INVITATION	Gadopiclenol vs Gadoxetate MRI for Liver Lesions
NCT07415018	Not specified	NOT_YET_RECRUITING	Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease
NCT06127810	Not specified	WITHDRAWN	MRI Gadopiclenol Enhanced Imaging of CNS Tumors

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).