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Optimark (GADOVERSETAMIDE)
Optimark (Gadoveretamide) is a paramagnetic contrast agent developed by Liebel-Flarsheim, used for magnetic resonance imaging (MRI). It is a small molecule modality that was FDA-approved in 1999 for its approved indications. As an off-patent drug with no active Orange Book patents, it is not commercially available as a generic. Optimark is used to enhance the visibility of internal structures during MRI procedures. Key safety considerations include its short half-life of 1.7 hours.
At a glance
| Generic name | GADOVERSETAMIDE |
|---|---|
| Sponsor | Liebel-Flarsheim |
| Drug class | Paramagnetic Contrast Agent |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 1999 |
Approved indications
- Magnetic resonance imaging
Common side effects
Key clinical trials
- Identification of Adverse Plaque Characteristics by Coronary MR Angiography (NA)
- Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies (NA)
- Contrast- Enhanced Whole-Heart Coronary MRA at 3.0T (Tesla) (PHASE1)
- Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection
- Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients (PHASE4)
- Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) (PHASE2)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |