Last reviewed 2026-04-20 · How we verify

Gadoterate

Gadoterate, marketed by Loyala University, is a contrast agent used in magnetic resonance imaging (MRI) to enhance image quality and diagnostic accuracy. A key strength of Gadoterate is its strong patent protection, with the key composition patent expiring in 2028, providing a significant barrier to generic competition. The primary risk is the lack of revenue data, which makes it challenging to assess the drug's market performance and potential financial impact.

At a glance

Approved indications

• Magnetic resonance imaging

Boxed warnings

• WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Clariscan is not approved for intrathecal use. ( 5.1 ) GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Clariscan in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m 2 ), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing ( 5.2 ). Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Clariscan is not approved for intrathecal use [see Warnings and Precautions (5.1) ]. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Clariscan in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. The risk for NSF appears highest among patients with: - Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m 2 ), or - Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g., age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing ( 5.2 ). For patients at highest risk for NSF, do not exceed the recommended Clariscan dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (5.2) ].

Common side effects

• Nausea
• Headache
• Injection Site Pain
• Injection Site Coldness
• Rash

Serious adverse events

• Nephrogenic Systemic Fibrosis
• Hypersensitivity/Anaphylactoid Reactions
• Cardiac Arrest
• Respiratory Arrest
• Bronchospasm
• Acute Respiratory Distress Syndrome
• Pulmonary Edema
• Acute Pancreatitis
• Convulsion
• Coma

Key clinical trials

• Dotarem vs Gadobutrol Contrast for Breast MRI (PHASE4)
• Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas (PHASE3)
• Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years (PHASE4)
• 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 (PHASE3)
• Diffusion MRI in Heart Failure (EARLY_PHASE1)
• 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) (PHASE3)
• Developing a New Metabolic Imaging Approach (aMRI) for Evaluating Neurological Disease in Patients With Gliomas
• 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 (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Gadoterate CI brief — competitive landscape report
• Gadoterate updates RSS · CI watch RSS
• Loyola University portfolio CI