Active Ingredient History
Gadobutrol is a second-generation extracellular non-ionic macrocyclic GBCA that is used in patients undergoing diagnostic contrast-enhanced MRI for visualization of pathological lesions in the CNS and all other body regions or for contrast-enhanced magnetic resonance angiography (MRA) to evaluate perfusion and flow-related abnormalities. It is a non-ionic, paramagnetic complex consisting of gadolinium (Gd3+) chelated with the macrocyclic compound dihydroxy-hydroxymethylpropyl-tetraazacyclododecane-triacetic acid (butrol). Gadavist (the trade name of gadobutrol) was approved by FDA in 2011 for intravenous use in diagnostic MRI in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Application of gadobutrol in humans, up to a dose of 0.5 mmol/kg was shown to be well tolerated. Following intravenous administration, gadobutrol may increase MRI sensitivity for the detection of tumors and inflammatory and demyelinating diseases of the central nervous system which are associated with areas with blood-brain barrier defects due to altered perfusion or an enlarged extracellular space. Gadobutrol is not metabolized. It is eliminated in an unchanged form via the kidneys; extra-renal elimination is negligible. Side effects include headache, nausea, abnormal taste and feeling hot. NCATS
Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
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Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
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Breast Neoplasms (approved 2011)
Central Nervous System Diseases (approved 2011)
Intracranial Arterial Diseases (approved 2013)
Renal Artery Obstruction (approved 2011)
Adenocarcinoma (Phase 2)
Allergy and Immunology (Phase 4)
Astrocytoma (Phase 1)
Bile Duct Neoplasms (Phase 1)
Brain Injuries, Traumatic (Phase 2)
Brain Neoplasms (Phase 3)
Breast Neoplasms (Phase 2)
Carcinoma, Bronchogenic (Phase 1)
Carcinoma, Non-Small-Cell Lung (Phase 3)
Carcinoma, Renal Cell (Phase 2)
Central Nervous System Neoplasms (Phase 2)
Colorectal Neoplasms (Phase 2)
Coronary Artery Disease (Phase 2/Phase 3)
Cranial Nerve Diseases (Phase 2)
Cystic Fibrosis (Phase 2)
Diffuse Intrinsic Pontine Glioma (Phase 1)
Drug-Related Side Effects and Adverse Reactions (Early Phase 1)
Dystonia (Phase 1/Phase 2)
Elbow (Phase 1/Phase 2)
Electronic Nicotine Delivery Systems (Phase 1)
Gallbladder Neoplasms (Phase 1)
Gastrointestinal Neoplasms (Phase 2)
Glioblastoma (Phase 1/Phase 2)
Glioma (Phase 2)
Gliosarcoma (Phase 1/Phase 2)
Graft Rejection (Phase 4)
Head and Neck Neoplasms (Phase 1)
Heart Transplantation (Phase 4)
Intestinal Neoplasms (Phase 1)
Kidney Neoplasms (Phase 2)
Laryngeal Neoplasms (Phase 1)
Leiomyosarcoma (Phase 2)
Leukemia (Phase 2)
Leukemia, Lymphocytic, Chronic, B-Cell (Phase 2)
Leukemia, Myeloid, Acute (Phase 1)
Lung Neoplasms (Phase 2)
Lymphoma (Phase 2)
Lymphoma, Non-Hodgkin (Phase 2)
Melanoma (Phase 2)
Meniere Disease (Phase 4)
Migraine Disorders (Phase 1/Phase 2)
Multiple Myeloma (Phase 2)
Myeloproliferative Disorders (Phase 1)
Myocardial Ischemia (Phase 2/Phase 3)
Nanoparticles (Phase 2)
Neoplasm Metastasis (Phase 3)
Neoplasms (Phase 3)
Nephrogenic Fibrosing Dermopathy (Phase 2/Phase 3)
Oligodendroglioma (Phase 1)
Oropharyngeal Neoplasms (Phase 1)
Ovarian Neoplasms (Phase 1)
Pancreatic Neoplasms (Phase 1)
Primary Immunodeficiency Diseases (Phase 1/Phase 2)
Prostatic Neoplasms (Phase 2)
Psoriasis (Phase 1/Phase 2)
Pulmonary Disease, Chronic Obstructive (Phase 1)
Pulmonary Embolism (Phase 4)
Radiation Oncology (Phase 2)
Radiosurgery (Phase 2)
Renal Insufficiency (Phase 2/Phase 3)
Small Cell Lung Carcinoma (Phase 2)
Squamous Cell Carcinoma of Head and Neck (Phase 1/Phase 2)
Stereotaxic Techniques (Phase 2)
Stroke (Phase 1/Phase 2)
Urogenital Neoplasms (Phase 2)
Urologic Neoplasms (Phase 2)
Trial | Phase | Start Date | Organizations | Indications |
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