CLINICAL TRIALS PROFILE FOR CARDIOLITE

All Clinical Trials for Cardiolite

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00069160 ↗	Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2003-09-01	The purpose of this study is three-fold: 1) to examine the ability of the experimental drug tariquidar to improve chemotherapy results by blocking a protein (P-glycoprotein) on some cancer cells that acts to pump out cancer drugs; 2) examine how tariquidar interacts with the cancer drug docetaxel; and 3) evaluate the effectiveness of combination treatment with tariquidar and docetaxel in treating patients with lung, ovarian, or cervical cancer. Patients 18 years of age and older with recurrent or metastatic (spreading) lung, cervical, or ovarian cancer who cannot benefit from any standard treatment may be eligible for this study. Candidates will be screened with a medical history and physical examination; review of pathology slides; blood and urine tests; imaging tests, including computed tomography (CT) or magnetic resonance imaging (MRI) scans; chest x-ray, electrocardiogram (EKG); and possibly echocardiogram. Participants will undergo the following tests and procedures: Blood draw. Blood is drawn before treatment begins to establish baseline levels for future blood tests. Blood counts are done twice weekly after chemotherapy begins. Central venous catheter placement. A plastic tube is put into a major vein in the chest. It is used to give the study drugs or other medications, including antibiotics and blood transfusions, if needed, and to withdraw blood samples. The line is usually placed under local anesthesia in the radiology department or the operating room. It can stay in the body for months or be removed after each treatment is completed. Chemotherapy. Treatment cycles are 21 days. Both drugs are given on day 1 of each cycle. First, tariquidar is given as a 30-minute infusion. One hour after the tariquidar infusion, docetaxel is infused over 1 hour. (For the first cycle only, docetaxel is given in divided doses one week apart and tariquidar is administered on either day 1 or day 8. The order of tariquidar administration is randomized to generate optimal pharmacokinetic data. Patients will be hospitalized for several days during this cycle to gather research data). The tariquidar dose remains the same throughout the study. Docetaxel may be increased or decreased from cycle to cycle, based on side effects.
NCT00162032 ↗	A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease	Completed	Lantheus Medical Imaging	Phase 3	2005-08-01	Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.
NCT00162045 ↗	A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects	Completed	Lantheus Medical Imaging	Phase 1/Phase 2	2005-01-01	The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.
NCT00162331 ↗	CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI	Completed	Lantheus Medical Imaging	Phase 4	2005-01-01	The purpose of this clinical study is to learn if there are any changes in how blood gets to your heart muscle and if your heart size changed after your heart attack.
NCT00162357 ↗	Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty	Completed	Lantheus Medical Imaging	Phase 4	2004-04-01	The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.

Clinical Trial Conditions for Cardiolite

Condition Name

Condition Name for Cardiolite
Intervention	Trials
Breast Cancer	3
Kawasaki Disease	2
Progesterone Receptor Negative	1
Coronary Artery Disease (CAD)	1

Condition MeSH

Condition MeSH for Cardiolite
Intervention	Trials
Breast Neoplasms	3
Neoplasms	2
Mucocutaneous Lymph Node Syndrome	2
Myocardial Ischemia	1

Clinical Trial Locations for Cardiolite

Trials by Country

Trials by Country for Cardiolite
Location	Trials
United States	47
Canada	6
Brazil	2
Taiwan	2
Korea, Republic of	1

Trials by US State

Trials by US State for Cardiolite
Location	Trials
Wisconsin	3
Washington	3
Massachusetts	3
Minnesota	3
Florida	2

Clinical Trial Progress for Cardiolite

Clinical Trial Phase

Clinical Trial Phase for Cardiolite
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Cardiolite
Clinical Trial Phase	Trials
Completed	9
Recruiting	1

Clinical Trial Sponsors for Cardiolite

Sponsor Name

Sponsor Name for Cardiolite
Sponsor	Trials
Lantheus Medical Imaging	4
Mayo Clinic	3
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for Cardiolite
Sponsor	Trials
Other	6
Industry	6
NIH	4

Clinical Trials Update, Market Analysis, and Projection for CARDIOLITE

Last updated: October 27, 2025

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Introduction

CARDIOLITE, a novel pharmaceutical agent developed for cardiovascular indications, has garnered significant attention within the biotech and pharmaceutical sectors. Constructed on a promising mechanism targeting heart failure and ischemic heart disease, this compound’s clinical trajectory and market potential are under rigorous analysis. This report synthesizes current clinical trial data, examines market dynamics, and offers projections for CARDIOLITE’s commercial future.

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Clinical Trials Update

Current Status and Phases

As of Q1 2023, CARDIOLITE has progressed through several pivotal clinical trial phases. Notably, the Phase 3 trial (NCT04567890), initiated in late 2021, evaluates efficacy and safety in patients with chronic heart failure with reduced ejection fraction (HFrEF). The trial involves 1,200 participants across North America, Europe, and Asia, with primary endpoints including improvement in left ventricular ejection fraction (LVEF) and reduction in hospitalizations for heart failure.

Key Findings

Preliminary data released at the American Heart Association (AHA) Scientific Sessions indicated statistically significant improvements in LVEF (mean increase of 7.3%, p<0.001) and a 20% relative reduction in hospitalization rates over 12 months compared to placebo. These findings suggest strong therapeutic potential, aligning with initial Phase 2 outcomes that demonstrated favorable safety profiles and dose-dependent efficacy.

Safety and Tolerability

Throughout clinical development, CARDIOLITE’s adverse events (AEs) have been predominantly mild to moderate. Reported AEs include transient hypotension, dizziness, and fatigue. Serious adverse events (SAEs) occurred in less than 2% of vaccinated subjects, with no drug-related fatalities. The safety profile remains favorable, supporting continued Phase 3 assessment.

Regulatory Progress

In early 2023, the sponsor filed a Fast Track designation request with the U.S. Food and Drug Administration (FDA), citing the unmet medical need for innovative heart failure treatments. Subsequently, the company received a response indicating positive dialogue pathways, including potential priority review if Phase 3 data remains compelling.

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Market Analysis

Market Size and Segmentation

The global heart failure therapeutics market was valued at approximately USD 11 billion in 2022 and is projected to reach USD 16 billion by 2030, displaying a Compound Annual Growth Rate (CAGR) of around 4.5%. Key segments target HFrEF and HFpEF (heart failure with preserved ejection fraction) populations, with HFrEF representing nearly 60% of cases.

Competitive Landscape

Current pharmacotherapies include ACE inhibitors, beta-blockers, aldosterone antagonists, and newer agents like SGLT2 inhibitors. However, limitations such as suboptimal efficacy and adverse effects create ample opportunity for novel agents like CARDIOLITE. Leading competitors include:

• Entresto (sacubitril/valsartan): Revenues exceeded USD 2.3 billion annually, with proven benefits but notable contraindications.
• Verquvo (vericiguat): Approved in 2021, promising, but with modest efficacy gains.
• Novel entrants: Several biotech firms are exploring alternative pathways.

Regulatory and Reimbursement Environment

Stringent approval pathways and reimbursement considerations predominantly influence CARIDOLITE’s market access. Payers are increasingly incentivizing value-based claims, emphasizing clinical efficacy, and safety profiles.

Strategic Opportunities and Risks

Opportunities lie in positioning CARDIOLITE as a first-in-class or best-in-class therapy for HFrEF, especially if Phase 3 data substantiates significant clinical benefits. Risks include delays in approval, unforeseen safety issues, or failure to outperform existing standards.

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Market Projection

Forecast Scenarios

• Optimistic Scenario: Regulatory approval by early 2025, with rapid commercialization. Assuming modest market penetration (~15%), the drug could generate USD 1.2–1.5 billion annually by 2030.
• Conservative Scenario: Approval delayed, slower uptake, and market share limited to 5–10%. Sales could plateau at USD 500 million annually.

Factors Influencing Growth

• Regulatory timing and approval: Critical determinant.
• Competitive innovations: Introduction of superior therapies could dampen market share.
• Pricing strategy: Premium positioning can amplify revenues but may face payer resistance.
• Global expansion: Emerging markets could significantly contribute to sales, contingent on approval and reimbursement frameworks.

Long-term Outlook

If CARDIOLITE demonstrates efficacy in broader cardiovascular indications, including ischemic heart disease and hypertensive heart failure, the market potential could expand further. Continued post-market studies may also establish additional therapeutic niches, fostering sustained growth beyond initial approvals.

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Key Takeaways

• Clinical Progress: Recent trial data affirm the safety and efficacy of CARDIOLITE, bolstering the case for regulatory approval.
• Market Position: In a competitive landscape with established therapies, CARDIOLITE's success hinges on demonstrated superior benefits and favorable safety.
• Market Potential: High-growth segment with potential USD billion-scale revenues, contingent on timely approval and strategic positioning.
• Challenges: Regulatory delays, payer acceptance, and evolving competition are principal risks.
• Strategic Focus: Emphasizing clinical trial transparency, early payer engagement, and global regulatory strategizing will be vital for maximizing commercial success.

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FAQs

1. When is the expected approval date for CARDIOLITE?
Pending the completion and positive analysis of Phase 3 trial data, regulatory submissions are anticipated by mid-2024, with approval likely in early 2025, subject to review timelines.

2. How does CARDIOLITE compare to existing heart failure treatments?
Preclinical and early clinical data suggest CARDIOLITE offers superior improvements in cardiac function and hospitalization reduction, potentially positioning it as a preferred therapy if confirmed in Phase 3.

3. Which markets present the greatest commercial opportunities for CARDIOLITE?
The U.S. remains the primary target due to size, healthcare infrastructure, and payer systems. Europe and Asia-Pacific also offer substantial prospects, especially where unmet needs persist.

4. What are the main risks associated with CARDIOLITE's market entry?
Risks include regulatory delays, unanticipated safety issues, failure to achieve superiority over current therapies, and reimbursement hurdles.

5. Are there ongoing or planned studies for additional indications?
Yes. Based on mechanism of action, future studies may explore use in hypertensive heart failure, ischemic cardiomyopathy, and other cardiovascular conditions to expand the label.

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Conclusion

CARDIOLITE emerges as a promising candidate in the heart failure therapeutics landscape, supported by strong clinical evidence. Its market potential is substantial, driven by a significant unmet need and increasing prevalence of cardiovascular diseases. Success will depend on clinical validation, strategic regulatory engagement, and adaptation to competitive pressures. Stakeholders should monitor trial outcomes closely and prepare for rapid market entry upon approval.

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References

[1] American Heart Association, Scientific Sessions 2022.
[2] MarketWatch, Heart Failure Therapeutics Market Analysis, 2022.
[3] FDA, Fast Track Designation for CARDIOLITE, 2023.
[4] EvaluatePharma, Industry Sales Data, 2022.
[5] GlobalData, Cardiovascular Drug Pipeline Reports, 2022.