Last Updated: June 9, 2026

CLINICAL TRIALS PROFILE FOR PROHANCE MULTIPACK


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PROHANCE MULTIPACK

Condition Name

Condition Name for PROHANCE MULTIPACK
Intervention Trials
Adult Brain Glioblastoma 1
Multiple Sclerosis 1
Brain Disease 1
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Condition MeSH

Condition MeSH for PROHANCE MULTIPACK
Intervention Trials
Breast Neoplasms 2
Diabetes Mellitus, Type 1 1
Brain Neoplasms 1
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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
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Trials by US State

Trials by US State for PROHANCE MULTIPACK
Location Trials
Alabama 3
Illinois 2
Ohio 2
North Carolina 2
Massachusetts 2
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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
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Clinical Trial Status

Clinical Trial Status for PROHANCE MULTIPACK
Clinical Trial Phase Trials
Completed 5
Recruiting 2
Not yet recruiting 1
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Clinical Trial Sponsors for PROHANCE MULTIPACK

Sponsor Name

Sponsor Name for PROHANCE MULTIPACK
Sponsor Trials
Bayer 2
University of Alabama at Birmingham 2
GEHC (Sponsor) 1
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Sponsor Type

Sponsor Type for PROHANCE MULTIPACK
Sponsor Trials
Other 10
Industry 4
NIH 1
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Last updated: May 3, 2026

Prohance Multipack: Clinical Trials Update, Market Analysis, and Market Projections

What is Prohance Multipack and how is it positioned?

ProHance Multipack is a bundled product format of gadoteridol (a gadolinium-based contrast agent, GBCAs) used for magnetic resonance imaging (MRI). It is marketed as a “multipack” arrangement intended to support facilities that administer gadoteridol across multiple imaging sessions without reordering individual units.

Core commercial attributes (product-bundle format)

  • Active ingredient: gadoteridol (GBCA)
  • Route/setting: MRI contrast administration
  • Product format: multipack (facility inventory optimization)
  • Intended use: diagnostic imaging enhancement in MRI

What clinical-trial activity is reported for Prohance Multipack?

No complete, attributable clinical-trial update can be produced for “Prohance Multipack” as a distinct investigational entity from the information available in the cited sources. Multipack packaging generally follows the regulatory pathway of the underlying marketed GBCA and does not generate separate, publicly attributable clinical efficacy/safety trials solely for the bundled packaging.

What is known about clinical evidence for the underlying drug (gadoteridol / ProHance)?

Gadoteridol’s clinical evidence base is established for MRI contrast enhancement. Public clinical programs are typically tied to the active ingredient and the labeled dosing and administration rather than the packaging format. Multipack variants generally inherit the clinical profile of the labeled product unless the format changes formulation, dosing regimen, or delivery device in a way that triggers new clinical studies.

Implication for “multipack” updates

  • Clinical endpoints for multipack packaging are not typically tracked separately from the underlying GBCA clinical dossier in publicly accessible registries.
  • Any “trial update” tied specifically to the multipack SKU is usually packaging-driven and does not create a new efficacy/safety narrative.

How does the GBCA market shape Prohance Multipack demand?

GBCAs remain large-volume products in radiology, with demand driven by:

  • MRI utilization rates
  • Scan protocols that include contrast enhancement
  • Hospital purchasing cycles and inventory management
  • Safety and regulatory positioning across the GBCA class
  • Substitution among competing gadolinium agents under formulary controls

Market dynamics that directly influence multipack bundles Multipack units tend to win in procurement models where radiology departments:

  • Seek predictable ordering cadence
  • Maintain contrast readiness for high-throughput schedules
  • Reduce ordering and receiving friction

Competitive set and substitution pressure

Prohance (gadoteridol) competes within the class of macrocyclic GBCAs, including (non-exhaustive):

  • Gadobutrol (Gadavist)
  • Gadoterate meglumine (Dotarem)
  • Gadoteridol generics and alternative branded offerings depending on region

Key competitive levers

  • Formulary preference for macrocyclic stability
  • Pricing and tender outcomes
  • Supply reliability
  • Packaging and logistics (unit counts per pack, expiry utilization planning)

Pricing and gross-to-net drivers for multipack purchasing

Multipack formats typically affect commercialization economics through:

  • Procurement efficiencies: reduced purchase orders and handling
  • Inventory optimization: fewer stockouts and fewer emergency reorders
  • Tender economics: volume pricing that aligns with annual MRI throughput forecasts

Market analysis: segmentation by customer type

Prohance Multipack demand is most sensitive to:

  1. Hospital radiology departments running mixed acute and elective MRI schedules
  2. Imaging centers with high throughput and standardized protocols
  3. National procurement groups that standardize GBCA selection by tender contracts

Demand translation

  • Higher MRI volumes and contrast utilization raise the baseline GBCA consumption.
  • Standardized imaging pathways increase consistency of GBCA selection, reducing churn but increasing share gains through formulary lock-in.
  • Multipack formats can shift share within a selected GBCA by improving procurement compatibility.

Forecast framework for Prohance Multipack (what drives unit growth)

Because multipack is a packaging configuration of a labeled GBCA, unit forecasts track:

  • MRI volume growth (scans)
  • Contrast-enhanced MRI proportion (penetration)
  • GBCA share of contrast exams
  • Market share for gadoteridol versus alternative agents
  • Conversion of single-unit purchasing to multipack bundles

Unit growth drivers (from a business planning standpoint)

  • Scanner and throughput growth: more MRI exams create more contrast administrations.
  • Protocol intensity: increases in contrast use and scan complexity raise GBCA dosing events.
  • Procurement consolidation: multipacks increase share in institutions that buy by bulk contract.
  • Substitution dynamics: competitive pricing and formulary updates can move share between macrocyclic GBCAs.

What market projections can be stated with sourced evidence?

No numeric market forecast for Prohance Multipack can be produced from the cited sources available in this environment. A complete projection requires sourced inputs such as:

  • GBCA category market size by geography and year
  • gadoteridol share within macrocyclic GBCAs
  • tender pricing history and conversion rates of packaging formats
  • MRI procedure forecasts and contrast utilization rates

No such quantified inputs are present in the provided evidence for this specific request.


Key Takeaways

  • Prohance Multipack is a packaging configuration of gadoteridol (a macrocyclic GBCA) used for contrast-enhanced MRI; its commercial performance follows the underlying gadoteridol demand curve.
  • A separate, publicly attributable clinical-trial update for “Prohance Multipack” is not typically generated by multipack packaging changes; clinical evidence is usually tied to the labeled gadoteridol dossier rather than the bundle format.
  • Multipack demand is driven by radiology purchasing behaviors: inventory readiness, procurement cycles, and tender volume economics.
  • No sourced numeric market forecast or quantified projection can be stated based on the currently available evidence.

FAQs

1) Does “Prohance Multipack” run separate clinical trials from ProHance?

Multipack SKUs generally inherit clinical labeling from the underlying gadoteridol product. Separate clinical trials are not typically conducted solely to support packaging bundling unless formulation, dosing regimen, or delivery mechanism changes in a way that requires new evidence.

2) What matters most commercially for Prohance Multipack?

Institutional purchasing behavior and formulary outcomes for macrocyclic GBCAs matter most, since multipacks primarily change logistics and procurement economics rather than core pharmacology.

3) What drives growth for multipack GBCA bundles?

MRI procedure volume growth, contrast-enhanced protocol penetration, and conversion to bulk procurement formats.

4) How does competition impact Prohance Multipack?

Competitive pressure comes from competing macrocyclic GBCAs and tender pricing, with formulary decisions determining which GBCA gets utilized and where multipacks can capture share through procurement convenience.

5) What should investors or R&D planners track?

Radiology tender awards, hospital formulary shifts among macrocyclic GBCAs, and evidence of packaging-format conversion (single units to multipacks) tied to annual purchasing contracts.


References

[1] FDA. Drug labeling and approvals for gadoteridol-containing products (ProHance). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/
[2] EMA. Public assessment and product information for gadoteridol-containing MRI contrast agents (ProHance and related products). European Medicines Agency. https://www.ema.europa.eu/
[3] ClinicalTrials.gov. Search results for gadoteridol-related studies and MRI contrast agent trials. https://clinicaltrials.gov/

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