CARDIOLITE
LOE Approachingtetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate
NDAINJECTIONINJECTABLE
Approved
Dec 1990
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
CARDIOLITE (tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate) is tc99m sestamibi is a cationic tc99m complex which has been found to accumulate in viable myocardial tissue in a manner analogous to that of thallous chloride tl-201. Approved for breast cancer. First approved in 1990.
Drug data last refreshed 2h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CARDIOLITE (Tc99m Sestamibi) is a radioactive diagnostic imaging agent approved for cardiac and breast imaging. It is a cationic technetium-99m complex that accumulates in viable myocardial tissue and certain breast lesions through mitochondrial electrostatic interactions. The drug enables scintigraphic visualization comparable to thallous chloride Tl-201 for detection of myocardial perfusion defects and breast lesions.
LOE Approaching
As a diagnostic imaging agent approaching loss of exclusivity with moderate competitive pressure, the brand team is likely focused on efficiency and managed care navigation rather than expansion.
Mechanism of Action
Tc99m Sestamibi is a cationic Tc99m complex which has been found to accumulate in viable myocardial tissue in a manner analogous to that of thallous chloride Tl-201. Scintigraphic images obtained in humans after the intravenous administration of the drug have been comparable to those obtained with…
Indications (1)
Clinical Trials (3)
A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
Started Aug 2005
445 enrolled
Kawasaki Disease
CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI
Started Jan 2005
74 enrolled
Myocardial Infarction
A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
Started Jan 2005
79 enrolled
Kawasaki Disease
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.