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Gadavist

(Gadobutrol)

Phase 1Small molecule

Gadobutrol is a contrast agent used during MRI scans to help doctors see blood vessels and tissues more clearly by making certain areas of the body show up better in the images.[1] Gadavist is currently being investigated across 8 indications[3], with its most advanced program in Phase 1.[1]

Gadavist is one of 227 small molecule programs targeting Breast Cancer. It is currently in Phase 1.

8

Indications

51

Total Trials

10

Active Trials

226

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Breast CancerActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

Pancreatic CancerActive, not recruiting

Multiple SclerosisActive, not recruiting

Ischemic Heart Disease (IHD)Recruiting

TreatmentCompleted

Cervical CancerActive, not recruiting

Gynecologic CancerRecruiting

Breast CancerPreclinical

Active, not recruiting

Hepatocellular CarcinomaPreclinical

Active, not recruiting

Pancreatic CancerPreclinical

Active, not recruiting

Multiple SclerosisPreclinical

Active, not recruiting

Ischemic Heart Disease (IHD)Preclinical

Recruiting

TreatmentPreclinical

Completed

Cervical CancerPhase 1

Active, not recruiting

Gynecologic CancerPhase 1

Recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Gadavist

Blenoxane

Bristol-Myers Squibb

Methylthioninium Chloride

PProvepharm SAS

Spravato

Acupan

YYonsei University

Chantix

PPrism Pharmaceuticals

Nubain

AAultman Health Foundation

Feraheme

AAzurity Pharmaceuticals

Vfend

PPrism Pharmaceuticals

Paracetamol

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 1Recruiting

Gynecologic Cancer

NCT04893434

Q3 2027

Post-ApprovalRecruiting

Contrast Agent

NCT07040865

Phase 1Active, not recruiting

Cervical Cancer

NCT04219904

Q4 2027

PreclinicalRecruiting

Central Nervous System

NCT07472491

Q1 2028

Phase 1Not yet recruiting

Study completion

NCT07796360

Clinical

Trials by Indication[1]

Magnetic Resonance Imaging (MRI)7 trials

Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain

Completed·BBracco Diagnostics, Inc·Phase 4·NCT01613417·229 enrolled

A Study for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions

Not yet recruiting·JJiangsu HengRui Medicine Co., Ltd.·Phase 2·NCT06731829·78 enrolled

Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients

Completed· Bayer logo

Bayer·Phase 3·NCT00395460·147 enrolled

Show 4 more trials

A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children

Completed· Bayer logo

Bayer·Phase 1·NCT00468819·140 enrolled

Study to Find the Appropriate Dose of a New Gadolinium-based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions

Completed· Bayer logo

Bayer·Phase 2·NCT04307186·57 enrolled

Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI)

Completed· Bayer logo

Bayer·Phase 3·NCT01104584·460 enrolled

A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over Phase III Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Body Parts (Non-Central Nervous System) Magnetic Resonance Imaging (MRI)

Completed·SShanghai Shengdi Pharmaceutical Co., Ltd·Phase 3·NCT07275723·309 enrolled

Contrast Agent3 trials

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

Completed· Bayer logo

Bayer·Phase 3·NCT05915702·303 enrolled

A Study Called GUS to Understand How Much of the Contrast Agent Gadavist is Used and How Much is Wasted in Two Different Containers (Single-dose Vials and Imaging Bulk Packages ) in a Real-world Setting

Completed· Bayer logo

Bayer··NCT05350189·1,602 enrolled

Randomized Comparison of Contrast Agents Gadopiclenol and Gadobutrol in the Workup of Incidental Renal and Adrenal Findings

Recruiting·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT07040865·104 enrolled

Central Nervous System3 trials

Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging

Completed· Bayer logo

Bayer·Phase 3·NCT00623467·343 enrolled

Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging

Completed· Bayer logo

Bayer·Phase 3·NCT00709852·402 enrolled

A Prospective, Multicenter Phase 2/3 Study to Assess the Efficacy and Safety of Mangaciclanol in Adult Patients With Known or Highly Suspected Lesions Referred for Contrast-Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) or Body (LUMINA)

Recruiting·GGE Healthcare·Preclinical·NCT07472491·640 enrolled

Magnetic Resonance Imaging3 trials

GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients

Completed· Bayer logo

Bayer··NCT01095081·23,775 enrolled

Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients in Magnetic Resonance Imaging

Completed· Bayer logo

Bayer··NCT00905879·30 enrolled

Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)

Recruiting·UUConn Health·Phase 4·NCT06846853·10 enrolled

Prostate Cancer2 trials

PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer

Withdrawn·NNorthwestern University·Phase 2·NCT04910425

Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI

Completed·MMayo Clinic·Phase 3·NCT03404648·19 enrolled

28 more indications

Pancreatic Cancer2 trials

The Role of the Tumor Microenvironment of Pancreatic Cancer to Predict Treatment Outcome

Completed·—·N/A·NCT01989000·47 enrolled

Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study

Completed·—·N/A·NCT01995240·23 enrolled

Coronary Artery Disease2 trials

Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)

Completed· Bayer logo

Bayer·Phase 3·NCT01890434·478 enrolled

Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)

Completed· Bayer logo

Bayer·Phase 3·NCT01890421·426 enrolled

MPA2 trials

Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose

Completed· Bayer logo

Bayer·Phase 4·NCT03602339·157 enrolled

Safety of Gadovist in Renally Impaired Patients

Completed· Bayer logo

Bayer·Phase 4·NCT00828737·927 enrolled

Multiple Sclerosis1 trial

Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases

Terminated·UUniversity of Southern California·N/A·NCT02967380·14 enrolled

Phase II1 trial

SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study

Completed· Bayer logo

Bayer·Phase 3·NCT00522951·165 enrolled

Gynecologic Cancer1 trial

Novel Imaging Technique to Assess Gynecologic Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT04893434·20 enrolled

Metastases1 trial

Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases

Completed·SStanford University·Phase 2·NCT00375830·114 enrolled

Cervical Cancer1 trial

PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04219904·25 enrolled

Fibrosis1 trial

Validation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV)

Completed·FFundacion Clinic per a la Recerca Biomédica·Phase 1·NCT02274246·9 enrolled

Breast1 trial

Dotarem vs Gadobutrol Contrast for Breast MRI

Completed·UUniversity of Massachusetts, Worcester·Phase 4·NCT03730051·300 enrolled

Treatment1 trial

Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions

Completed·MM.D. Anderson Cancer Center·N/A·NCT04132843·6 enrolled

Drug1 trial

Drug Use Investigation of Gadovist.

Completed· Bayer logo

Bayer··NCT02540967·3,357 enrolled

Tics1 trial

Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)

Completed· Bayer logo

Bayer··NCT00874640·3,711 enrolled

CAR1 trial

Myocardial Perfusion MRI

Completed· Bayer logo

Bayer·Phase 2·NCT01490294·232 enrolled

ESS1 trial

Gadobutrol Enhanced MRA of the Supra-aortic Vessels

Completed· Bayer logo

Bayer·Phase 3·NCT01344447·479 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging

Completed· Bayer logo

Bayer·Phase 3·NCT01660841·223 enrolled

ART1 trial

Gadobutrol Enhanced MRA of the Renal Arteries

Completed· Bayer logo

Bayer·Phase 3·NCT01344460·317 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI

Completed· Bayer logo

Bayer·Phase 3·NCT01067976·446 enrolled

Age1 trial

MR Image Synthesis With Low Gadobutrol Dose and AI

Completed·SSubtle Medical·Phase 1·NCT06224543·60 enrolled

Vascular Disease1 trial

Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients

Completed· Bayer logo

Bayer·Phase 3·NCT00395733·83 enrolled

Pediatric1 trial

Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

Completed· Bayer logo

Bayer·Phase 1·NCT01544166·44 enrolled

Ischemic Heart Disease (IHD)1 trial

The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States (SPINS2) Study

Recruiting·BBrigham and Women's Hospital·Preclinical·NCT06854458·1,000 enrolled

Contrast Enhancement in Magnetic Resonance Imaging1 trial

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Completed· Bayer logo

Bayer·Phase 3·NCT05915728·410 enrolled

Interstitial Cystitis1 trial

Phenotyping Interstitial Cystitis/Bladder Pain Syndrome by ICE-MRI Bladder Permeability Assay

Completed·CChristopher J Chermansky, MD··NCT05811377·7 enrolled

For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions1 trial

A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Completed·SShanghai Shengdi Pharmaceutical Co., Ltd·Phase 3·NCT07275814·250 enrolled

Lesion in Body Region1 trial

Efficacy and Safety of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children

Completed·GGuerbet·Phase 3·NCT06010173·240 enrolled

Hepatocellular Carcinoma1 trial

Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI

Active, not recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT02156739·100 enrolled

Unspecified3 trials

Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years

Recruiting·GGuerbet·Phase 4·NCT04373564·2,076 enrolled

Gadobutrol Magnevist-controlled Body Study

Completed· Bayer logo

Bayer·Phase 3·NCT01050829·370 enrolled

Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast

Not yet recruiting·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT07796360·15 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 18, 2013

GADAVIST

NDA NDA201277

Sources

References

[1]
ClinicalTrials.gov — 51 trial records for Gadobutrol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Gadobutrol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Gadobutrol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA201277). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: Bayer

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