CLINICAL TRIALS PROFILE FOR PROHANCE MULTIPACK

All Clinical Trials for Prohance Multipack

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.

Clinical Trial Conditions for Prohance Multipack

Condition Name

Condition Name for Prohance Multipack
Intervention	Trials
Brain Disease	1
Triple Negative Breast Cancer	1
Brain Metastases	1
Triple Negative Breast Cancer Stage II-IV	1

Condition MeSH

Condition MeSH for Prohance Multipack
Intervention	Trials
Breast Neoplasms	2
Diabetes Mellitus	1
Sclerosis	1
Coronary Disease	1

Clinical Trial Locations for Prohance Multipack

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Prohance Multipack

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Prohance Multipack
Clinical Trial Phase	Trials
Completed	5
Recruiting	2
Unknown status	1

Clinical Trial Sponsors for Prohance Multipack

Sponsor Name

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

Sponsor Type

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

ProHance Multipack: Clinical Trials, Market Analysis, and Projections

Introduction to ProHance Multipack

ProHance Multipack, a gadolinium-based contrast agent, is widely used in magnetic resonance imaging (MRI) to visualize lesions in the central nervous system, spine, and associated tissues, as well as in the head and neck. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Experience

Trial Design and Participants

ProHance was evaluated in two multicenter trials involving 310 evaluable patients suspected of having neurological pathology. Additionally, it was tested in a broader clinical setting involving 3174 subjects, including 2896 adults and 278 pediatric subjects aged 0 to 17 years. The demographic distribution included 78% Caucasian, 6% Black, 3% Hispanic, 6% Asian, and 2% other ethnicities, with 5% of the subjects' race not reported[1][4].

Adverse Reactions

The clinical trials revealed that approximately 5.8% of the subjects reported one or more adverse reactions within 24 hours to 7 days after ProHance administration. The most common adverse reactions included nausea (1.4%), dysgeusia (0.9%), headache (0.7%), dizziness (0.4%), and urticaria (0.4%)[1][4].

Post-Marketing Experience

Post-marketing reports have identified additional adverse reactions not observed in the clinical trials, such as fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems. These reactions highlight the need for continuous monitoring and reporting[1].

Market Analysis

Current Market Trends

The global market for clinical trial packaging, which includes drugs like ProHance, is experiencing significant growth. This is driven by the increasing number of clinical trials, particularly post-COVID-19, and the rising incidence of chronic and lifestyle diseases. The market is projected to grow from $4.13 billion in 2024 to $8.54 billion by 2032, at a CAGR of 9.51%[3].

Factors Influencing Market Growth

Several factors are contributing to the market growth:

• Increased R&D Activities: The surge in research and development activities in biotechnology and pharmaceutical companies is driving the demand for clinical trial packaging and related products.
• Outsourcing of Clinical Trials: The trend of outsourcing clinical trials to various regions is also propelling market growth.
• Government Support: Significant support from international organizations like the WHO has boosted market growth, especially during the COVID-19 pandemic[3].

Market Projections for ProHance Multipack

Indications and Usage

ProHance Multipack is indicated for MRI in adults and pediatric patients, including term neonates, to visualize lesions with disrupted blood-brain barriers and/or abnormal vascularity in the brain, spine, and associated tissues, as well as lesions in the head and neck in adults. This broad range of indications positions ProHance Multipack as a versatile and essential tool in diagnostic imaging[2][4].

Market Demand

Given the increasing need for advanced diagnostic tools, especially in neurology and oncology, the demand for ProHance Multipack is expected to rise. The growing incidence of neurological disorders and the need for precise imaging will drive the market for this drug.

Competitive Landscape

The market for gadolinium-based contrast agents is competitive, but ProHance Multipack's efficacy, safety profile, and wide range of indications make it a strong contender. Continuous innovation in packaging and administration, such as the multipack format, enhances its appeal to healthcare providers.

Future Outlook

Technological Advancements

The adoption of smart packaging and wearable devices in clinical trials is expected to emerge as a key trend, potentially enhancing the delivery and monitoring of drugs like ProHance Multipack. This could improve patient compliance and data collection, further boosting the market[3].

Regulatory Considerations

Regulatory bodies are increasingly focusing on the safety and efficacy of gadolinium-based contrast agents due to concerns about gadolinium retention in the body. ProHance Multipack's manufacturer will need to comply with evolving regulatory standards to maintain market presence[5].

Key Takeaways

• Clinical Trials: ProHance Multipack has been evaluated in extensive clinical trials, showing a favorable safety profile with manageable adverse reactions.
• Market Growth: The market for clinical trial packaging and related products is growing significantly, driven by increased R&D activities and outsourcing of clinical trials.
• Indications: ProHance Multipack is indicated for a broad range of MRI applications, making it a versatile diagnostic tool.
• Future Outlook: The market demand for ProHance Multipack is expected to rise due to the growing need for advanced diagnostic imaging, with technological advancements and regulatory compliance playing crucial roles.

FAQs

What are the common adverse reactions associated with ProHance Multipack?

The most common adverse reactions include nausea, dysgeusia, headache, dizziness, and urticaria[1][4].

What are the indications for ProHance Multipack?

ProHance Multipack is indicated for MRI to visualize lesions in the central nervous system, spine, and associated tissues, as well as in the head and neck in adults and pediatric patients, including term neonates[2][4].

How is ProHance Multipack administered?

The recommended dose is 0.2 mL/kg (0.1 mmol/kg) body weight administered as a rapid intravenous infusion or bolus, followed by a saline flush of at least 5 mL normal saline[5].

What are the post-marketing adverse reactions reported for ProHance Multipack?

Post-marketing reports have identified adverse reactions such as fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems[1].

What is the projected market growth for clinical trial packaging, and how does it impact ProHance Multipack?

The global clinical trial packaging market is projected to grow from $4.13 billion in 2024 to $8.54 billion by 2032, at a CAGR of 9.51%. This growth trend is expected to positively impact the demand for ProHance Multipack due to its role in diagnostic imaging[3].

Sources

1. RxList: ProHance (Gadoteridol Injection Solution) - Clinical Trials Experience.
2. RxList: ProHance Multipack (Gadoteridol Injection) - Description and Uses.
3. Fortune Business Insights: Clinical Trial Packaging Market Size & Detailed Analysis [2032].
4. Bracco: ProHance® Multipack™ - Medication Guide.
5. DailyMed: PROHANCE- gadoteridol injection, solution - Label.