CLINICAL TRIALS PROFILE FOR DEFINITY

All Clinical Trials for Definity

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00162058 ↗	A Phase II Study of DMP 115 to Assess Focal Liver Lesions	Completed	Lantheus Medical Imaging	Phase 2	2004-03-01	To determine the optimal dose of DMP 115 to image liver lesions and to assess whether contrast can improve the detection of focal liver lesions.
NCT00162370 ↗	A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease	Completed	Lantheus Medical Imaging	Phase 4	2004-04-01	The study is designed to see if stress echocardiography can be used as a screening exam in peri-, or post-menopausal women with a risk of developing of coronary artery disease and experiencing future cardiac events.
NCT00239525 ↗	3-D Transcranial Ultrasound Analysis Study	Completed	Duke University	N/A	2006-05-01	The purpose of this study is to investigate real time 3-D ultrasound imaging of the brain for the diagnosis and evaluation of stroke.
NCT00401687 ↗	DMP115 in Patients With an Ejection Fraction Between 25%-40% to Evaluate the Use of Contrast Echocardiography to Assess Heart Function	Completed	Lantheus Medical Imaging	Phase 4	2006-07-01	The purpose of this clinical research study is to demonstrate the ability of Definity® enhanced versus unenhanced cardiac ultrasound to improve the accuracy and reproducibility of left ventricular ejection fraction (EF) when compared to magnetic resonance imaging (MRI).
NCT00507806 ↗	Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke	Terminated	ImaRx Therapeutics	Phase 1/Phase 2	2005-03-01	The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
NCT00580580 ↗	Detection of Coronary Stenosis With Intravenous Microbubbles	Withdrawn	University of Nebraska	N/A	2012-02-01	To detect coronary artery disease by both coronary and carotid artery imaging and myocardial perfusion imaging using a new low mechanical index real time system.

Clinical Trial Conditions for Definity

Condition Name

Condition Name for Definity
Intervention	Trials
Breast Cancer	6
Hepatocellular Carcinoma	4
Kidney Cancer	3
Coronary Artery Disease	3

Condition MeSH

Condition MeSH for Definity
Intervention	Trials
Breast Neoplasms	6
Carcinoma, Renal Cell	5
Carcinoma	5
Heart Diseases	5

Clinical Trial Locations for Definity

Trials by Country

Trials by Country for Definity
Location	Trials
United States	110
Canada	5
Switzerland	1
United Kingdom	1
India	1

Trials by US State

Trials by US State for Definity
Location	Trials
Pennsylvania	15
North Carolina	12
California	12
Minnesota	9
Texas	8

Clinical Trial Progress for Definity

Clinical Trial Phase

Clinical Trial Phase for Definity
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	5
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Definity
Clinical Trial Phase	Trials
Completed	29
Recruiting	15
Not yet recruiting	6

Clinical Trial Sponsors for Definity

Sponsor Name

Sponsor Name for Definity
Sponsor	Trials
Lantheus Medical Imaging	18
Thomas Jefferson University	8
National Cancer Institute (NCI)	7

Sponsor Type

Sponsor Type for Definity
Sponsor	Trials
Other	87
Industry	28
NIH	14

Clinical Trials, Market Analysis, and Projections for Definity (Perflutren Lipid Microsphere)

Last updated: January 1, 2025

Introduction to Definity

Definity, also known as perflutren lipid microsphere, is a widely used ultrasound enhancing agent. Recently, it has received significant attention due to its expanded approval for use in pediatric patients.

FDA Approval for Pediatric Use

In March 2024, the FDA approved the supplemental new drug application (sNDA) for Definity as an ultrasound enhancing agent for pediatric patients with suboptimal echocardiograms. This approval is based on data from three pediatric clinical trials: the Golding study, the Fine study, and the Kutty study[1][5].

Clinical Trials Overview

• Golding Study: Evaluated 40 patients aged 1 month to 17 years with significant cardiovascular disorders, including heart transplant, Kawasaki disease, or congenital cardiovascular anomalies.
• Fine Study: Evaluated 36 patients aged 10 to 21 years who had previously undergone a heart transplant.
• Kutty Study: A retrospective medical record review of 113 pediatric patients aged 5 to 21 years with known congenital or acquired heart disease or suspected cardiac disease.

These studies collectively evaluated the use of Definity in 189 patients, with 107 (56.5%) males and 82 (43.5%) females, substantiating its efficacy and safety in pediatric patients[1][5].

Market Presence and Dominance

Definity holds a significant market presence, particularly in the U.S. It is the most utilized, extensively studied, and trusted diagnostic ultrasound enhancing agent, with approximately 80% market share in the U.S. for ultrasound contrast imaging agents[3].

Market Analysis

Current Market Position

Definity's approval for pediatric use marks a significant expansion of its market. Given its extensive use and trust among healthcare professionals, it is expected to maintain its dominant position in the ultrasound contrast agent market.

Competitive Landscape

The ultrasound contrast agent market is relatively niche, but Definity's strong market share and recent FDA approval for pediatric use solidify its position. However, the market could see competition from generic versions once the patents expire. Currently, Definity is protected by ten patents in the U.S. and seventy-two patent family members in seventeen countries[3].

Projections and Future Outlook

Market Growth

The approval for pediatric use is expected to drive further growth for Definity. As the most trusted and widely used ultrasound enhancing agent, it is likely to see increased adoption in pediatric cardiology.

Financial Projections

While specific financial projections for Definity are not publicly available, its expanded indication is expected to contribute positively to Lantheus Holdings, Inc.'s revenue. The company's rigorous research and development efforts, as highlighted by the FDA approval, indicate a strong commitment to maintaining and growing its market share[5].

Impact on Pediatric Medicine

Enhanced Diagnostic Capabilities

The approval of Definity for pediatric patients provides healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border. This enhances diagnostic accuracy, particularly in cases where echocardiograms are suboptimal[1][5].

Patient Outcomes

By improving diagnostic capabilities, Definity is expected to contribute to better patient outcomes in pediatric cardiology. The ability to accurately diagnose and monitor cardiovascular conditions in young patients is crucial for effective treatment and management.

Challenges and Considerations

Patent Expiration

Definity's patents are set to expire, which could lead to the entry of generic versions. However, the complexity of producing ultrasound contrast agents and the trust built around Definity may mitigate the immediate impact of generics[3].

Regulatory Environment

Continued regulatory approvals and compliance will be crucial for Definity's market position. The recent FDA approval for pediatric use underscores the importance of ongoing clinical trials and data collection to support future indications.

Key Takeaways

• FDA Approval: Definity has been approved for use in pediatric patients with suboptimal echocardiograms based on three clinical trials.
• Market Dominance: Definity holds approximately 80% market share in the U.S. for ultrasound contrast imaging agents.
• Clinical Trials: The Golding, Fine, and Kutty studies substantiated the efficacy and safety of Definity in pediatric patients.
• Future Outlook: The expanded indication is expected to drive growth and maintain Definity's market position.
• Impact on Pediatric Medicine: Enhanced diagnostic capabilities and better patient outcomes are anticipated.

FAQs

What is Definity used for?

Definity, or perflutren lipid microsphere, is used as an ultrasound enhancing agent to improve the visibility of the left ventricular chamber and endocardial border, particularly in cases where echocardiograms are suboptimal.

What is the significance of the recent FDA approval for Definity?

The recent FDA approval extends the use of Definity to pediatric patients with suboptimal echocardiograms, providing a valuable diagnostic tool for healthcare professionals in pediatric cardiology.

How dominant is Definity in the market?

Definity holds approximately 80% market share in the U.S. for ultrasound contrast imaging agents, making it the most utilized and trusted diagnostic ultrasound enhancing agent.

What are the potential challenges for Definity in the future?

Definity faces potential challenges from patent expiration and the entry of generic versions, although its strong market position and trust among healthcare professionals may mitigate these effects.

How does Definity impact patient outcomes in pediatric cardiology?

Definity enhances diagnostic accuracy, allowing for better identification and monitoring of cardiovascular conditions in young patients, which is crucial for effective treatment and management.

Sources

1. Medthority: FDA approval of Definity (perflutren lipid microsphere) for pediatric patients with suboptimal echocardiograms.
2. GlobalData: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
3. DrugPatentWatch: DEFINITY RT Drug Patent Profile.
4. GlobeNewswire: Lantheus Announces the FDA Approval of DEFINITY® (Perflutren Lipid Microsphere) for Pediatric Patients.
5. Biospace: Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034.