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Flyrcado (FLURPIRIDAZ)
Flyrcado emits radiation to create detailed images of the heart, allowing for the diagnosis of coronary artery disease and other heart conditions.
Flyrcado (flurpiridaz) is a radioactive diagnostic agent developed by Ge Hlthcare for the imaging of coronary artery disease, myocardial ischemia, and infarction. It is a small molecule that works by emitting radiation to create detailed images of the heart. Flyrcado is a patented product with no generic manufacturers available, and it was FDA-approved in 2024. Key safety considerations include the potential risks associated with radiation exposure. As a radioactive agent, Flyrcado requires careful handling and administration to minimize exposure to healthcare workers and patients.
At a glance
| Generic name | FLURPIRIDAZ |
|---|---|
| Sponsor | Ge Hlthcare |
| Drug class | Radioactive Diagnostic Agent [EPC] |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
Flurpiridaz F 18 is an analog of the mitochondrial complex 1 (MC-1) inhibitor, pyridaben. Flurpiridaz F 18 is extracted by the myocardium proportional to the blood flow and binds to heart tissue that has biologically active mitochondria. Therefore, radioactivity in viable myocardium is higher than in infarcted tissue.
Approved indications
- coronary artery disease
- myocardial ischemia
- infarction
Common side effects
- Dyspnea
- Headache
- Angina pectoris
- Chest pain
- Fatigue
- ST segment changes
- Flushing
- Nausea
- Abdominal pain
- Dizziness
- Arrhythmia
- Diarrhea
Key clinical trials
- Ultralow Dose PET Imaging of 18F-flurpiridaz (PHASE2)
- A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes (PHASE2)
- An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD) (PHASE3)
- A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD. (PHASE3)
- Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |