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 4m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CARDIOLITE (Tc99m Sestamibi) is a Tc99m-labeled cationic complex injectable diagnostic radiopharmaceutical approved for breast cancer imaging. It accumulates in viable myocardial and breast tissue via electrostatic interactions with mitochondria, enabling scintigraphic visualization comparable to thallous chloride Tl-201.
LOE Approaching
As a diagnostic product approaching loss of exclusivity with moderate competitive pressure (30/100), brand teams face contraction and transition to generic competition.
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.