FLYRCADO (flurpiridaz f-18)
Flyrcado is a radioactive diagnostic agent used for PET imaging of the heart in adults who have or are suspected of having coronary artery disease. It helps clinicians evaluate blood flow to the heart muscle during both resting and active states, such as exercise or pharmacologic stress. By using this imaging tool, healthcare providers can identify areas of the heart experiencing reduced blood flow or permanent damage from a previous heart attack.
How FLYRCADO Works
This agent works by binding to mitochondrial complex 1 within heart tissue that contains active mitochondria. The drug is absorbed by the heart muscle in proportion to the amount of blood flow it receives. This allows for a clear distinction in radioactivity levels between healthy, viable heart tissue and areas that have been infarcted.
Details
- Status
- Prescription
- First Approved
- 2024-09-27
- Patent Cliff
- 2042
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
FLYRCADO Approval History
What FLYRCADO Treats
3 indicationsFLYRCADO is approved for 3 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coronary Artery Disease
- Myocardial Ischemia
- Myocardial Infarction
FLYRCADO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to FLYRCADO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FLYRCADO FDA Label Details
Indications & Usage
FDA Label (PDF)FLYRCADO is indicated for the treatment of Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction.
FLYRCADO Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for FLYRCADO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 7 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.