CLINICAL TRIALS PROFILE FOR PROHANCE

All Clinical Trials for Prohance

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00522951 ↗	SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study	Completed	Bayer	Phase 3	2007-08-01	This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.
NCT00709852 ↗	Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging	Completed	Bayer	Phase 3	2008-06-01	This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.
NCT01019486 ↗	Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D)	Completed	University of Colorado, Denver	Phase 4	2009-11-01	Cardiovascular disease (CVD) remains the major cause of mortality and morbidity in both type 1 (T1D) and type 2 (T2D) diabetes patients; modifications of traditional CVD risk factors have had a limited impact. This project called Regadenoson Blood flow in Type 1 Diabetes (RABIT1D) and is proposed as a sub-study of the Coronary Artery Calcification in Type 1 Diabetes (CACTI) study, which has established a unique cohort of 656 T1D patients (age 20-55, minimal diabetes duration of 10 yrs) and 764 non-diabetic controls. This cohort is being followed for progression of coronary artery calcification (CAC) measured using the electron beam tomography (EBT) for development of clinical CVD. Participants have been well characterized during the baseline examination (4/00-3/02) and two follow-up re-examinations 3 and 6 years later. The study has provided important insights into the risk factors and possible prevention of premature CVD in T1D. We are proposing assess a subset of this population to determine vasodilatory reserve as it relates to early coronary atherosclerosis in T1D. Hypothesis: that myocardial blood imaging (MBF) reserve can be measured in Type 1 diabetes mellitus (DM) using regadenoson stress cardiac magnetic resonance and that significantly reduced MBF is a marker of extensive atherosclerotic disease correlated to coronary arterial calcification, plaque formation and impaired vasodilatory reserve.
NCT01613417 ↗	Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain	Completed	Bracco Diagnostics, Inc	Phase 4	2012-08-01	This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.
NCT02359097 ↗	Steady State Blood Volume Maps Using Ferumoxytol Non-stoichiometric Magnetite MRI in Imaging Patients With Glioblastoma	Completed	National Cancer Institute (NCI)	N/A	2015-01-06	This clinical trial studies steady state blood volume maps using ferumoxytol non-stoichiometric magnetite magnetic resonance (MRI) in imaging patients with glioblastoma. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. Contrast agents, such as ferumoxytol non-stoichiometric magnetite, may enhance these pictures and increase visibility of tumor cells and the blood vessels in and around the tumors.
NCT02359097 ↗	Steady State Blood Volume Maps Using Ferumoxytol Non-stoichiometric Magnetite MRI in Imaging Patients With Glioblastoma	Completed	Oregon Health and Science University	N/A	2015-01-06	This clinical trial studies steady state blood volume maps using ferumoxytol non-stoichiometric magnetite magnetic resonance (MRI) in imaging patients with glioblastoma. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. Contrast agents, such as ferumoxytol non-stoichiometric magnetite, may enhance these pictures and increase visibility of tumor cells and the blood vessels in and around the tumors.

Clinical Trial Conditions for Prohance

Condition Name

Condition Name for Prohance
Intervention	Trials
Brain Metastases	1
Triple Negative Breast Cancer Stage II-IV	1
Central Nervous System Diseases	1
Type 1 Diabetes Mellitus	1

Condition MeSH

Condition MeSH for Prohance
Intervention	Trials
Breast Neoplasms	2
Triple Negative Breast Neoplasms	1
Neoplasm Metastasis	1
Diabetes Mellitus, Type 1	1

Clinical Trial Locations for Prohance

Trials by Country

Trials by Country for Prohance
Location	Trials
United States	28
Japan	16
Germany	11
Colombia	4
Austria	4

Trials by US State

Trials by US State for Prohance
Location	Trials
Alabama	3
Massachusetts	2
Illinois	2
Ohio	2
North Carolina	2

Clinical Trial Progress for Prohance

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Prohance
Clinical Trial Phase	Trials
Completed	5
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for Prohance

Sponsor Name

Sponsor Name for Prohance
Sponsor	Trials
Bayer	2
University of Alabama at Birmingham	2
Bracco (Sponsor)	1

Sponsor Type

Sponsor Type for Prohance
Sponsor	Trials
Other	10
Industry	4
NIH	1

ProHance (Gadoteridol): Clinical Trials, Market Analysis, and Projections

Introduction

ProHance, also known as Gadoteridol, is a macrocyclic nonionic gadolinium-based contrast agent used in magnetic resonance imaging (MRI) to enhance the visualization of the brain, spine, and surrounding tissues. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Patient Demographics and Adverse Reactions

Clinical trials involving ProHance have been extensive, encompassing 3174 subjects, including 2896 adults and 278 pediatric subjects aged 0 to 17 years. The trials showed that approximately 5.8% of subjects reported one or more adverse reactions during a follow-up period ranging from 24 hours to 7 days after administration. Common adverse reactions included nausea (1.4%), dysgeusia (0.9%), headache (0.7%), dizziness (0.4%), and urticaria (0.4%)[1].

Pediatric Studies

A significant development in the clinical trials of ProHance is its approval for use in pediatric patients under two years of age, including term neonates. A Phase 3 retrospective study (Study PH-108) involving 125 pediatric patients from 1 day to 24 months of age demonstrated the efficacy and safety of ProHance in this age group. The study found no serious adverse events or discontinuations due to adverse events in the pediatric population. Mild to moderate adverse events related to changes in clinical laboratory parameters were reported but resolved without sequelae[4][5].

Regulatory Approvals

FDA and Health Canada Approvals

ProHance has received approvals from both the U.S. Food and Drug Administration (FDA) and Health Canada for its use in pediatric patients under two years of age. The FDA approved ProHance for this expanded indication in December 2020, reinforcing its safety profile in term neonates and young children[5].

In Canada, Health Canada approved the supplemental new drug submission to include pediatric patients less than 2 years of age, based on favorable benefit-harm-uncertainty profiles from clinical trials and post-marketing surveillance[4].

Market Analysis

Market Position

ProHance is noted as the fastest-growing gadolinium-based contrast agent (GBCA) on the market. Its approval for pediatric use has further expanded its market reach, making it a preferred choice for MRI procedures in both adult and pediatric populations[5].

Competitive Landscape

The market for GBCAs is competitive, with several other agents available. However, ProHance's unique macrocyclic structure and its nonionic nature contribute to its safety profile, particularly in pediatric and sensitive patient populations. This differentiation helps ProHance maintain a strong market position[2].

Market Projections

Growth Potential

Given its recent approvals and expanding indications, ProHance is expected to see significant growth in the coming years. The inclusion of pediatric patients under two years of age opens up a new segment of the market, increasing the potential user base and revenue.

Revenue Impact

The approval for pediatric use is likely to boost sales, as it addresses a critical need for safe and effective contrast agents in young children. The market is expected to grow as more healthcare providers adopt ProHance for MRI procedures in pediatric patients.

Future Developments and Challenges

Ongoing Research and Development

While ProHance has established itself as a reliable contrast agent, ongoing research and development in the field of diagnostic imaging may introduce new competitors or technologies. However, its strong safety profile and regulatory approvals position it well to adapt to future market changes.

Regulatory and Safety Considerations

Continuous monitoring of safety data and adherence to regulatory requirements will be crucial for maintaining market approval and trust. The absence of serious adverse events in clinical trials bodes well for its long-term market viability.

Key Takeaways

• Clinical Trials: ProHance has been tested in extensive clinical trials, showing a favorable safety profile in both adult and pediatric populations.
• Regulatory Approvals: Recent approvals from the FDA and Health Canada for use in pediatric patients under two years of age have expanded its market reach.
• Market Position: ProHance is the fastest-growing GBCA, with a strong market position due to its safety profile and unique chemical structure.
• Growth Potential: The inclusion of pediatric patients is expected to drive significant growth in the coming years.
• Future Developments: Ongoing research and adherence to regulatory requirements will be key to maintaining its market position.

FAQs

What is ProHance used for?

ProHance (Gadoteridol) is used as a contrast agent in magnetic resonance imaging (MRI) to enhance the visualization of the brain, spine, and surrounding tissues.

What are the common adverse reactions associated with ProHance?

Common adverse reactions include nausea, dysgeusia, headache, dizziness, and urticaria.

Has ProHance been approved for use in pediatric patients?

Yes, ProHance has been approved by the FDA and Health Canada for use in pediatric patients under two years of age, including term neonates.

What makes ProHance unique in the market?

ProHance is a macrocyclic nonionic gadolinium-based contrast agent, which contributes to its safety profile, particularly in pediatric and sensitive patient populations.

What are the future growth prospects for ProHance?

Given its recent approvals and expanding indications, ProHance is expected to see significant growth in the coming years, particularly with the inclusion of pediatric patients under two years of age.

Sources

1. RxList: ProHance (Gadoteridol Injection Solution) - RxList
2. DrugBank: Gadoteridol: Uses, Interactions, Mechanism of Action - DrugBank
3. Marinus Pharmaceuticals: Marinus Pharmaceuticals Provides Update on the Phase 3 RAISE Trial and Reports Preliminary First-Quarter 2024 Financial Results
4. Health Canada: Regulatory Decision Summary for ProHance
5. PR Newswire: FDA Approves Bracco Diagnostics Inc.'s ProHance® (Gadoteridol) Injection for Pediatric Patients Younger Than Two Years