Last reviewed · How we verify
Clariscan
At a glance
| Generic name | Clariscan |
|---|---|
| Sponsor | GE Healthcare |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
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) a
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
- Angioedema
- Acute Respiratory Distress Syndrome
- Pulmonary Edema
- Acute Pancreatitis
- Convulsion
Key clinical trials
- In Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance Imaging (PHASE1)
- A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries
- Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients (PHASE3)
- To Evaluate Dose and Safety of NanoEcho Particle-1 Using NanoEcho Imaging Device Examinations of Rectal Lymph Nodes in Healthy Volunteers and Rectal Cancer Patients. (PHASE2)
- A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus
- Metabolic Imaging in Carotid Atherosclerosis
- Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation (PHASE2)
- Validation of USPIO-enhanced MRI for Detection of Lymph Node Metastases in Head and Neck Carcinoma (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Clariscan CI brief — competitive landscape report
- Clariscan updates RSS · CI watch RSS
- GE Healthcare portfolio CI