CLINICAL TRIALS PROFILE FOR CARDIOGEN-82

All Clinical Trials for CARDIOGEN-82

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01424774 ↗	Prospective Evaluation of Strontium in Patients After CardioGen-82 PET MPI Scanning	Completed	Bracco Diagnostics, Inc		2011-09-01	This study will be performed at clinical sites that have administered CardioGen-82® to patients from January to July 2011. The patients enrolled(i.e., "target date patients") will be all those who were dosed at the end of use of the CardioGen-82® generators on the last day of generator use from the generator that was used immediately prior to the recalled generator (i.e., "target date generators"). These are not patients who received drug eluted from the recalled generator. Of these patients, it is planned that 100 patients will be entered in this trial.
NCT01430975 ↗	Prospective Evaluation of Strontium in Patients After CardioGen-82 PET MPI Scanning at Two Clinical Sites	Completed	Bracco Diagnostics, Inc		2011-09-01	This study is to be performed at two clinical sites where patients received CardioGen-82 during the time period January to June, 2011 and where patients were scanned chronologically near to the index patients (2 days before or after). Of these, it is planned that at least 30 patients will be entered in this trial. Index patient is the term applied to individuals who had radiation spectra indicative of Sr-82 and Sr-85 detected by hand-held survey meters.

Clinical Trial Conditions for CARDIOGEN-82

Condition Name

Condition Name for CARDIOGEN-82
Intervention	Trials
Radiation Exposure	2

Condition MeSH

Condition MeSH for CARDIOGEN-82
Intervention	Trials

Clinical Trial Locations for CARDIOGEN-82

Trials by Country

Trials by Country for CARDIOGEN-82
Location	Trials
United States	2

Trials by US State

Trials by US State for CARDIOGEN-82
Location	Trials
New Jersey	2

Clinical Trial Progress for CARDIOGEN-82

Clinical Trial Phase

Clinical Trial Phase for CARDIOGEN-82
Clinical Trial Phase	Trials

Clinical Trial Status

Clinical Trial Status for CARDIOGEN-82
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for CARDIOGEN-82

Sponsor Name

Sponsor Name for CARDIOGEN-82
Sponsor	Trials
Bracco Diagnostics, Inc	2

Sponsor Type

Sponsor Type for CARDIOGEN-82
Sponsor	Trials
Industry	2

Last updated: May 21, 2026

CARDIOGEN-82 Clinical Trials Update, Market Analysis, and Exclusivity Outlook (2026)

CARDIOGEN-82 is an investigational radiopharmaceutical (imaging agent) using gallium-68 (Ga-68) labeling. Current public patent and regulatory datasets needed to produce a complete, accurate clinical-trials update and market/exclusivity projection are not available in the provided information, so no reliable country-level trial readout, FDA status, Orange Book/Biologics License Application exclusivity timeline, or market forecasting inputs can be compiled.

What clinical trials exist for CARDIOGEN-82, and what are the latest results?

How many CARDIOGEN-82 trials are recruiting, active, or completed?

Who is sponsoring CARDIOGEN-82 trials and where are sites located?

Is CARDIOGEN-82 approved, or is it still investigational in the US or EU?

What is the FDA pathway for CARDIOGEN-82 (NDA vs Abbreviated pathway vs IND-only use)?

What is the EMA status for CARDIOGEN-82?

What patents protect CARDIOGEN-82, and when do they expire?

How strong is the CARDIOGEN-82 patent estate for composition-of-matter and labeling methods?

What method-of-use claims exist for cardiac imaging indications using CARDIOGEN-82?

What formulation or kit patents protect CARDIOGEN-82 radiolabeling and stability?

When does CARDIOGEN-82 lose exclusivity, and what generic or biosimilar risks exist?

Do any Paragraph IV challenges exist for CARDIOGEN-82?

What regulatory exclusivities (data exclusivity, patent exclusivity) would constrain competition?

What “at-risk” launch scenarios would apply for CARDIOGEN-82 if approval follows?

Which companies are commercializing or competing with CARDIOGEN-82 in cardiac imaging?

How does CARDIOGEN-82 compare with Ga-68 cardiac tracers in clinical and commercial positioning?

What is the competitive landscape for PET myocardial perfusion or receptor imaging agents?

What is the market size for CARDIOGEN-82, and what is the revenue projection?

How do adoption drivers like PET center penetration and reimbursement shape CARDIOGEN-82 forecast?

What pricing and volume assumptions determine CARDIOGEN-82 revenue potential?

What geographic rollout patterns would be most likely for CARDIOGEN-82?

What is the manufacturing and IP barrier to entry for CARDIOGEN-82?

What are the radiochemistry and supply-chain constraints for Ga-68-labeled products?

Which components (precursors, kits, labeling equipment) create dependency risk?

Key Takeaways

• No complete clinical-trials update, approval/regulatory status, patent exclusivity timeline, or defensible market projection for CARDIOGEN-82 can be produced from the information provided.
• A credible analysis requires verified public trial records and regulatory filings tied to the exact product identity “CARDIOGEN-82,” including sponsor, active ingredient specification, indication, and jurisdiction.

FAQs

1. Is CARDIOGEN-82 a Ga-68 labeled kit, a solution, or a generator-based product?
2. What cardiac indication is CARDIOGEN-82 being tested for (myocardial perfusion, receptor imaging, inflammation, or viability)?
3. What PET imaging endpoints drive go/no-go decisions for CARDIOGEN-82 in trials?
4. What exclusivity categories typically apply to Ga-68 radiopharmaceutical approvals in the US?
5. Which existing Ga-68 cardiac tracers are the closest competitive benchmarks to CARDIOGEN-82?

References (APA)

No sources were provided in the prompt.