Drug updated on 3/28/2025
Dosage Form | Injection (intravenous; 190 MBq/mL to 2,050 MBq/mL (5 mCi/mL to 55 mCi/mL) in a shielded multiple-dose vial with up to 30 mL fill volume) |
Drug Class | Radioactive diagnostic agents |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction
Latest News

Summary
- This summary is based on the review of two randomized controlled trial(s). [1-2]
- Among evaluable patients (mean age 63.7 ± 9.5 years; 32.5% women; 52.3% with Body Mass Index (BMI) ≥ 30 kg/m²), flurpiridaz Positron Emission Tomography (PET) showed higher sensitivity (80.3%) than Single Photon Emission Computed Tomography (SPECT) (68.7%; P = 0.0003), with noninferior specificity (63.8% vs. 61.7%; P = 0.0004); the Area Under the Receiver Operating Characteristic (ROC) curve was greater for flurpiridaz PET (0.80 vs. 0.68; P < 0.001).
- Among evaluable patients (mean age 62.3 ± 9.5 years; 31% women; 55% with BMI ≥ 30 kg/m²; 71% undergoing pharmacological stress), flurpiridaz PET had higher sensitivity (71.9% [95% Confidence Interval (CI): 67.0%–76.3%]) than SPECT (53.7% [95% CI: 48.5%–58.8%]; P < 0.001), but specificity (76.2% [95% CI: 71.8%–80.1%]) did not meet noninferiority to SPECT (86.6% [95% CI: 83.2%–89.8%]; P = Not Significant [NS]); flurpiridaz PET showed superior ROC performance in the overall population, women, obese patients, and those undergoing pharmacological stress (P < 0.001 for all).
- Flurpiridaz PET was reported to be safe and well tolerated, with no significant safety concerns or adverse effects mentioned.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Flyrcado (flurpiridaz F 18) Prescribing Information. | 2024 | GE Healthcare Inc., Marlborough, MA, USA |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease | 730Subjects F: 0% M: 100% | 2023 | Journal of the American College of Cardiology |
Phase-III Clinical Trial of Fluorine-18 Flurpiridaz Positron Emission Tomography for Evaluation of Coronary Artery Disease | 755Subjects F: 0% M: 100% | 2020 | Journal of the American College of Cardiology |
Document Title
Sex Distribution:
F:0%
M:100%
730Subjects
Year:
2023
Source:Journal of the American College of Cardiology
Document Title
Sex Distribution:
F:0%
M:100%
755Subjects
Year:
2020
Source:Journal of the American College of Cardiology