Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Flurpiridaz (18F) Injection
Flurpiridaz · 1 trial · 2 indications
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader difference of SRS for PET MPI was reported.
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. Summed score of the 17 segments SRS was used for analysis. SR% is calculated by dividing the SRS by a number corresponding to the SRS value indicating a deficit of 4 in every segment and then multiplying the result by 100. Intra-reader difference of SR% for PET MPI was reported.
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader correlation of SRS for PET MPI assessed using Pearson's correlation was reported.
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader correlation of SRS for PET MPI assessed using Kendall's tau-b was reported.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence: SPE-SPE | EXPERIMENTAL | Participants received 2 intravenous (IV) boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2. The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 millicurie (mCi) (63 to 93 megabecquerel \[MBq\]) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant. |
| Treatment Sequence: HPLC-HPLC | EXPERIMENTAL | Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2. The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant. |
| Treatment Sequence: SPE-HPLC | EXPERIMENTAL | Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by 2 different processes (1 dose manufactured by SPE followed by 1 dose manufactured by HPLC) at Visit 1 and 2. The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant. |
| Treatment Sequence: HPLC-SPE | EXPERIMENTAL | Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by 2 different processes (1 dose manufactured by HPLC followed by 1 dose manufactured by SPE) at Visit 1 and 2. The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant. |
| Name | Type | Description |
|---|---|---|
| Flurpiridaz (18F) Injection | DRUG | All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein at rest. |
Inclusion Criteria: * \* The participant was a man or woman ≥18 years of age * The participant was undergoing evaluation of known CAD or for suspected CAD with an intermediate to high PTP. * The participant had read, signed, and dated an informed consent form (ICF) prior to any study procedure...
Top 11 of 23 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 7 | PHASE3 | Inclisiran, YMI024 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 4 | PHASE3 | Ziltivekimab |
| Viatris, Inc. | VTRS | 2 | PHASE3 | Selatogrel |
| Alnylam Pharmaceuticals, Inc | ALNY | 1 | PHASE3 | Zilebesiran |
| NewAmsterdam Pharma Company N.V. | NAMS | 1 | PHASE3 | Obicetrapib |
| GE Healthcare Technologies Inc. | GEHC | 3 | PHASE1 | Regadenoson |
| Humacyte, Inc. | HUMA | 1 | PHASE2 | CTEV |
| AstraZeneca PLC | AZN | 1 | - | Tezepelumab |
| Sanofi SA Sponsored ADR | SNY | 2 | - | alirocumab |
| Bayer | BAYRY | 1 | PHASE1 | Nurandociguat |
| Hoffmann-La Roche | RHHBY | 1 | PHASE1 | RO7763505 |
Flurpiridaz is an investigational PET imaging agent being studied for the assessment of myocardial perfusion in patients with coronary artery disease (CAD) and ischemic heart disease. It is designed to help visualize blood flow to the heart muscle during PET imaging procedures.
Flurpiridaz is being developed by GE HealthCare Technologies Inc., which trades on the Nasdaq under the ticker GEHC. The company is responsible for the clinical development and potential commercialization of the imaging agent.
Flurpiridaz is in Phase 2 clinical development. It has not been approved by the FDA and remains an investigational product. The Phase 2 program includes one completed trial evaluating the imaging agent in patients with coronary artery disease.
Flurpiridaz has been evaluated in a completed Phase 2 trial, NCT04594941, titled "A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes." The trial enrolled 38 participants with coronary artery disease or ischemic heart disease in the United States.
Yes, Flurpiridaz (18F) Injection is another name for flurpiridaz. The "(18F)" designation refers to the fluorine-18 radioisotope used in the formulation. Both names refer to the same investigational PET imaging agent being developed by GE HealthCare.