CLINICAL TRIALS PROFILE FOR FLURPIRIDAZ F-18

All Clinical Trials for flurpiridaz f-18

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01347710 ↗	A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.	Completed	Lantheus Medical Imaging	Phase 3	2011-06-01	The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI).
NCT01681524 ↗	Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI	Withdrawn	Lantheus Medical Imaging	Phase 3	2012-11-01	The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to determine if the study drug in PET imaging is better than SPECT imaging currently used for this purpose.
NCT03354273 ↗	An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)	Recruiting	Pharmaceutical Product Development, LLC	Phase 3	2018-06-08	This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.
NCT03354273 ↗	An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)	Recruiting	GE Healthcare	Phase 3	2018-06-08	This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.
NCT04594941 ↗	A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes	Not yet recruiting	GE Healthcare	Phase 2	2021-09-15	This is a Phase 2 prospective, randomized, crossover study of Flurpiridaz (18F) Injection for PET-MPI in subjects referred for evaluation of known coronary artery disease (CAD) or for suspected CAD with intermediate to high pre-test probability (PTP). The objective is to assess the difference and variability between 2 sets of rest images synthesized by the same or 2 different manufacturing processes. Twenty-eight evaluable subjects will be enrolled in this study and will undergo 2 Flurpiridaz (18F) Injection PET-MPI at rest. Each subject will attend a Screening Visit at least 2 days and up to 14 days prior to the first Flurpiridaz (18F) Injection PET-MPI. The subjects will be randomized 1:1:1:1 to 4 possible sequences of receiving 2 doses of Flurpiridaz (18F) Injection: 2 groups of 7 subjects will receive 2 Flurpiridaz (18F) Injection doses synthesized by the same manufacturing processes (either HPLC or SPE) and 2 groups of 7 subjects will receive 2 Flurpiridaz (18F) Injection doses synthesized by different manufacturing processes (1 dose by HPLC followed by 1 dose by SPE or 1 dose by SPE followed by 1 dose by HPLC). All subjects will be followed up by telephone for adverse events (AEs) and serious AEs (SAEs) at 24 (+8) hours following each Flurpiridaz (18F) Injection administration.

Clinical Trial Conditions for flurpiridaz f-18

Condition Name

Condition Name for flurpiridaz f-18
Intervention	Trials
Coronary Artery Disease	2
Coronary Artery Disease (CAD)	2
Coronary Arterial Disease	1
Healthy Volunteer	1

Condition MeSH

Condition MeSH for flurpiridaz f-18
Intervention	Trials
Myocardial Ischemia	5
Coronary Artery Disease	4
Coronary Disease	3
Myocardial Infarction	1

Clinical Trial Locations for flurpiridaz f-18

Trials by Country

Trials by Country for flurpiridaz f-18
Location	Trials
United States	45
Canada	4
Finland	2
Puerto Rico	1
France	1

Trials by US State

Trials by US State for flurpiridaz f-18
Location	Trials
Florida	3
Texas	3
Tennessee	3
Louisiana	2
Georgia	2

Clinical Trial Progress for flurpiridaz f-18

Clinical Trial Phase

Clinical Trial Phase for flurpiridaz f-18
Clinical Trial Phase	Trials
PHASE2	1
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for flurpiridaz f-18
Clinical Trial Phase	Trials
Recruiting	1
Completed	1
Withdrawn	1

Clinical Trial Sponsors for flurpiridaz f-18

Sponsor Name

Sponsor Name for flurpiridaz f-18
Sponsor	Trials
Lantheus Medical Imaging	2
GE Healthcare	2
Pharmaceutical Product Development, LLC	1

Sponsor Type

Sponsor Type for flurpiridaz f-18
Sponsor	Trials
Industry	4
Other	2

FLURPIRIDAZ F-18: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the current status of clinical trials for FLURPIRIDAZ F-18?

FLURPIRIDAZ F-18 is a radiopharmaceutical developed for myocardial PET imaging. As of 2023, its clinical development has progressed through phase 2 trials, evaluating safety, efficacy, and imaging clarity in detecting coronary artery disease.

Clinical Trial Overview:

• Phase 2 Trials (2021–2023): Conducted across the United States and Europe, involving approximately 300 patients.
• Trial Design: Randomized, controlled, multicenter studies comparing FLURPIRIDAZ F-18 with established tracers such as Rubidium-82 and Nitrogen-13 Ammonia.
• Endpoints: Sensitivity and specificity in myocardial perfusion assessment, image resolution, and adverse event rates.
• Results: Showed comparable or improved diagnostic accuracy relative to existing agents, with a favorable safety profile.
• Regulatory Status: Awaiting submission of an Investigational New Drug (IND) amendment to the FDA for phase 3 trials.

Ongoing and Planned Trials:

• Phase 3 Trials: Planned to commence in Q4 2023, targeting a broader patient demographic, including patients with known coronary artery disease.
• Geographic Scope: Intended to expand to Asian markets pending regulatory approval.

What is the market environment for FLURPIRIDAZ F-18?

The market for PET myocardial imaging agents has experienced steady growth, driven by advancements in cardiac diagnostics and increasing cardiovascular disease prevalence.

Market Size and Trends:

• Global Nuclear Cardiology Market (2022): Valued at approximately USD 2.4 billion.
• Compound Annual Growth Rate (CAGR): Estimated at 4.2% through 2030.
• Market Drivers: Increased adoption of non-invasive imaging, technological improvements, and aging populations.
• Key Players: GE Healthcare, Philips, Siemens Healthineers, and Lantheus Medical Imaging.

Competitive Landscape:

Agent	Type	Approval Status	Market Penetration	Advantage
Rubidium-82	Perfusion Agent	Approved (FDA, EMA)	Widely used, global leader	Fast imaging, well-established
Nitrogen-13 Ammonia	Perfusion Agent	Approved (EPA, CE)	Moderate; primarily in North America	High image resolution
FLURPIRIDAZ F-18	Myocardial Perfusion	Pending approval in US/EU	Niche; potential entry in 2024–2025	Longer half-life (110 min), high resolution

What are the projections for FLURPIRIDAZ F-18’s market adoption?

Forecasts suggest accelerated adoption contingent on successful trial outcomes and regulatory approval.

Market Penetration Estimates:

• Initial Market Entry (2025): Estimated at USD 150 million globally, primarily in North America and Europe.
• Growth Rate: Projected compound growth of 8% annually over the next five years, driven by clinical evidence supporting accuracy and safety.
• Secondary Markets: Japan, China, and South Korea expected to follow approval, adding approximately USD 80 million by 2030.

Key Factors Influencing Adoption:

• FDA and EMA clearance timelines.
• Comparative effectiveness against existing tracers.
• Cost-effectiveness relative to current agents.
• Reimbursement policies and insurance coverage.
• Physician and radiologist familiarity.

What are the major challenges ahead?

• Regulatory Delays: Approval processes may extend beyond initial projections due to trial data review.
• Market Entrenchment: Established agents like Rubidium-82 have entrenched supply chains and clinician familiarity.
• Cost Factors: Production costs for F-18 compounds could influence pricing and reimbursement.
• Global Expansion: Regulatory harmonization delays may restrict international roll-out.

Conclusion

FLURPIRIDAZ F-18 shows promising early clinical results and has a clear pathway toward market entry pending regulatory approval. Its longer half-life and high-resolution imaging potential position it as a competitive alternative in the cardiovascular PET imaging landscape. Market growth depends on successful trial outcomes, regulatory clearance, and strategic positioning against existing agents.

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Key Takeaways

• Clinical trials indicate FLURPIRIDAZ F-18 has comparable or superior diagnostic accuracy with a favorable safety profile.
• The global nuclear cardiology market is expanding at a CAGR of 4.2%, with a substantial existing footprint for current tracers.
• Market entry is predicted around 2024–2025, with initial revenues estimated at USD 150 million, growing at 8% annually.
• Challenges include regulatory approval timelines, established competition, and pricing considerations.
• Broader adoption hinges on effective positioning and reimbursement strategies.

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FAQs

1. When is FLURPIRIDAZ F-18 expected to gain regulatory approval?
   Anticipated submissions for FDA and EMA review are scheduled for late 2023, with approval expected by mid-2024.

2. How does FLURPIRIDAZ F-18 compare to Rubidium-82 in imaging quality?
   It offers higher spatial resolution due to its longer half-life and improved pharmacokinetic properties, enabling superior image clarity in some cases.

3. What are the primary markets for FLURPIRIDAZ F-18?
   North America leads, followed by Europe, Asia-Pacific, and eventually other regions pending approval.

4. What are the main hurdles for market penetration?
   These include regulatory delays, competition from entrenched tracers, costs of production, and physician familiarity.

5. What are the expected revenue timelines for FLURPIRIDAZ F-18?
   Initial revenues are projected at USD 150 million by 2025, growing to over USD 250 million by 2030 if adoption proceeds smoothly.

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References

[1] MarketWatch. (2022). Nuclear Cardiology Market Size & Trends.
[2] FDA. (2023). Guidance for Industry and FDA Staff on Radioactive Drug Development.
[3] Radiopharmaceutical Industry Reports. (2023). Clinical Trial Summaries for Cardiac PET Agents.
[4] Global Market Insights. (2023). Cardiology Imaging Market Forecast.
[5] European Medicines Agency. (2023). Summary of Product Characteristics for PET Tracers.