Gadobutrol

Summary

Gadobutrol (CHEMBL2218860) is an approved small molecule (ATC V08CA09); indicated across 8 conditions including central nervous system disorder and neoplasm.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: V08CA09
• Indications: 8 conditions
• Clinical trials: 48

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2218860
Name	Gadobutrol
Type	Small molecule
Max phase	4
ATC	V08CA09

Also known as: Gadavist, Gadobutrol, Gadograf, Gadovist, Protovist, ZK 135079, ZK-135079, GADOBUTROL, gadobutrol

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

8 indications (0 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
central nervous system disorder	3	MONDO:0002602	EFO:0009386
neoplasm	2	MONDO:0005070	MONDO:0004992
congestive heart failure	1	MONDO:0005009	EFO:0000373
rheumatoid arthritis	1	MONDO:0008383	EFO:0000685
female reproductive system neoplasm	1	MONDO:0021148	MONDO:0021148
urinary bladder neoplasm	0	MONDO:0004987	EFO:0000294
interstitial cystitis	0	MONDO:0018301	EFO:0008507

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

Clinical trials

Total trials: 48.

Phase distribution

Phase	Trials
PHASE3	16
Not specified	12
PHASE4	6
PHASE1	6
PHASE2	5
EARLY_PHASE1	2
PHASE2/PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04373564	PHASE4	RECRUITING	Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
NCT05215132	PHASE4	RECRUITING	Investigational MRI Clinical Software and Hardware
NCT00907530	PHASE4	COMPLETED	Study to Compare MultiHance With Gadovist in Magnetic Resonance Imaging (MRI) of the Brain
NCT01026389	PHASE4	COMPLETED	Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease
NCT01613417	PHASE4	COMPLETED	Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain
NCT03730051	PHASE4	COMPLETED	Dotarem vs Gadobutrol Contrast for Breast MRI
NCT07275723	PHASE3	ACTIVE_NOT_RECRUITING	A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Body Parts (Non-Central Nervous System) Lesions
NCT07275814	PHASE3	RECRUITING	A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Central Nervous System (CNS) Lesions
NCT07472491	PHASE2/PHASE3	RECRUITING	A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients
NCT00395460	PHASE3	COMPLETED	Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
NCT00395733	PHASE3	COMPLETED	Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
NCT00522951	PHASE3	COMPLETED	SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
NCT00623467	PHASE3	COMPLETED	Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging
NCT00709852	PHASE3	COMPLETED	Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging
NCT01067976	PHASE3	COMPLETED	Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI
NCT01104584	PHASE3	COMPLETED	Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI)
NCT01890421	PHASE3	COMPLETED	Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
NCT01890434	PHASE3	COMPLETED	Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
NCT03404648	PHASE3	COMPLETED	Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI
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)
NCT05915702	PHASE3	COMPLETED	A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems
NCT05915728	PHASE3	COMPLETED	A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)
NCT06731829	PHASE2	NOT_YET_RECRUITING	A Study for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions
NCT00375830	PHASE2	COMPLETED	Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
NCT01490294	PHASE2	COMPLETED	Myocardial Perfusion MRI
NCT02796729	PHASE2	TERMINATED	CEST- Glucose Enhanced MRI for Metastatic Brain Tumours
NCT04910425	PHASE2	WITHDRAWN	PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer
NCT04893434	PHASE1	ACTIVE_NOT_RECRUITING	Novel Imaging Technique to Assess Gynecologic Cancer
NCT00468819	PHASE1	COMPLETED	A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children
NCT02135861	PHASE1	COMPLETED	A Method Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure
NCT02274246	PHASE1	COMPLETED	Validation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV)
NCT02350426	PHASE1	TERMINATED	A Study to Assess Inflammation in Rheumatoid Arthritis Using Molecular Imaging Techniques
NCT06224543	PHASE1	COMPLETED	MR Image Synthesis With Low Gadobutrol Dose and AI
NCT04219904	EARLY_PHASE1	ACTIVE_NOT_RECRUITING	PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer
NCT05811377	EARLY_PHASE1	COMPLETED	Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay
NCT02156739	Not specified	ACTIVE_NOT_RECRUITING	Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions
NCT06854458	Not specified	RECRUITING	The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study
NCT07415018	Not specified	NOT_YET_RECRUITING	Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease
NCT00804128	Not specified	COMPLETED	Contrast-Enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)

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).