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Flurpiridaz F18 · 1 trial · 1 indication
Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard,
Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard
| Arm | Type | Description |
|---|---|---|
| Flurpiridaz F18 | EXPERIMENTAL | Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to a single dose of 99mTc sestamibi or tetrofosmin for SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization |
| Name | Type | Description |
|---|---|---|
| Flurpiridaz F18 | DRUG | Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis |
| 99mTechnicium (sestamibi or tetrofosmin) | DRUG | Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis |
Inclusion Criteria: Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details. Exclusion Criteria: Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control. Unstable cardiac status. History of coronary artery by...
Flurpiridaz F18 is an investigational small molecule being developed for use in patients with Coronary Artery Disease (CAD). It is a positron emission tomography (PET) imaging agent intended to assess myocardial perfusion. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Flurpiridaz F18 is a PET imaging agent that targets the mitochondrial complex 1 (MC-1) in myocardial tissue. By binding to this target, it allows for the visualization of blood flow to the heart muscle, which helps in the assessment of Coronary Artery Disease. The imaging agent is designed to provide diagnostic information about myocardial perfusion.
Flurpiridaz F18 is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker symbol LNTH. Lantheus is a biopharmaceutical company focused on developing diagnostic imaging agents. The drug is currently in Phase 3 clinical trials for the assessment of Coronary Artery Disease.
Flurpiridaz F18 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory authority. The Phase 3 trial, which has been completed, enrolled 795 patients with Coronary Artery Disease to evaluate the safety and efficacy of the PET imaging agent.
Flurpiridaz F18 has one completed Phase 3 clinical trial registered under NCT01347710. The trial, titled 'A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD,' enrolled 795 patients across the United States, Canada, Finland, and Puerto Rico. The study was uncontrolled and not randomized or double-blinded.
Yes, Flurpiridaz F18 is the same as Flurpiridaz F 18. The drug is referred to by both names in clinical trial documentation. The Phase 3 study NCT01347710 uses the name 'Flurpiridaz F 18 Injection' to describe the investigational PET imaging agent being developed for Coronary Artery Disease assessment.