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CLINICAL TRIALS PROFILE FOR ELUCIREM

All Clinical Trials for elucirem

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05590884 ↗	Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age	Recruiting	Guerbet	Phase 2	2022-09-21	This Phase II open-label, uncontrolled, multicenter trial is designed to investigate the pharmacokinetic (PK) profile of gadopiclenol in plasma, in pediatric patients aged up to 23 months inclusive (term neonates or preterm infants after the neonatal period), using a population PK approach. Primary objective is to evaluate the PK profile of gadopiclenol in plasma following single intravenous injection of 0.05 mmol/kg body weight (BW) in pediatric population aged up to 23 months (inclusive) scheduled for a contrast-enhanced MRI examination of any body region including central nervous system (CNS).
NCT05954559 ↗	High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment	Not yet recruiting	Guerbet	Phase 4	2024-09-01	Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. The product was approved in 2022 by FDA to be used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). However, given its at least twofold higher relaxivity than other GBCAs, the performance of Elucirem in cardiac MR (CMR) has yet to be demonstrated. The hypothesis for the study: Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment. All participants will be selected from the investigators previous CMR study cohort with double-dose Dotarem T1 mapping and LGE images. Ten participants without scars will be recruited for the Phase I dose evaluation. Five for 0.05 mmol/kg and five for 0.075 mmol/kg. The investigators have identified 15 participants with LGE findings from double-dose Dotarem CMR acquired in the years 2021, 2022, or earlier years. This study was performed in August 2022. The same protocol will be used for single-dose Elucirem.
NCT05954559 ↗	High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment	Not yet recruiting	Johns Hopkins University	Phase 4	2024-09-01	Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. The product was approved in 2022 by FDA to be used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). However, given its at least twofold higher relaxivity than other GBCAs, the performance of Elucirem in cardiac MR (CMR) has yet to be demonstrated. The hypothesis for the study: Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment. All participants will be selected from the investigators previous CMR study cohort with double-dose Dotarem T1 mapping and LGE images. Ten participants without scars will be recruited for the Phase I dose evaluation. Five for 0.05 mmol/kg and five for 0.075 mmol/kg. The investigators have identified 15 participants with LGE findings from double-dose Dotarem CMR acquired in the years 2021, 2022, or earlier years. This study was performed in August 2022. The same protocol will be used for single-dose Elucirem.
NCT06057168 ↗	Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas	Recruiting	Guerbet	Phase 3	2023-09-07	This trial aims to study the performance of Elucirem® (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas.

Clinical Trial Conditions for elucirem

Condition Name

Condition Name for elucirem
Intervention	Trials
Pediatric Disorder	1
Body Indication	1
Brain Tumor, Primary	1
Brain Tumor, Recurrent	1

Condition MeSH

Condition MeSH for elucirem
Intervention	Trials
Central Nervous System Diseases	1
Brain Neoplasms	1
Fibrosis	1
Nervous System Diseases	1

Clinical Trial Locations for elucirem

Trials by Country

Trials by Country for elucirem
Location	Trials
United States	3
Poland	2
Hungary	2
Italy	1
Bulgaria	1

Trials by US State

Trials by US State for elucirem
Location	Trials
Maryland	1
South Carolina	1
Ohio	1

Clinical Trial Progress for elucirem

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for elucirem
Clinical Trial Phase	Trials
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for elucirem

Sponsor Name

Sponsor Name for elucirem
Sponsor	Trials
Guerbet	3
Johns Hopkins University	1

Sponsor Type

Sponsor Type for elucirem
Sponsor	Trials
Industry	3
Other	1

Elucirem Market Analysis and Financial Projection

ELUCIREM: A Revolutionary MRI Contrast Agent

Introduction

ELUCIREM, also known as gadopiclenol, is a groundbreaking macrocyclic gadolinium-based contrast agent (GBCA) approved by the U.S. Food and Drug Administration (FDA) in September 2022. Developed by Guerbet, this drug has been hailed for its high relaxivity and reduced gadolinium dose, making it a significant advancement in MRI imaging.

Clinical Trials Overview

The FDA approval of ELUCIREM was based on extensive clinical trials involving 1,047 patients or healthy volunteers who received at least one dose of the drug. Here are the key points from these trials:

• Trial Participants and Sites: The clinical trials included two pivotal studies conducted at 33 sites in 11 countries. These trials enrolled patients with central nervous system (CNS) lesions and those with lesions outside the CNS[1][3][4].
• Efficacy Studies: The trials evaluated the efficacy of ELUCIREM in improving image quality for MRI scans. The drug was administered to visualize lesions in the CNS and the body, with three independent, blinded readers assessing the images for border delineation, internal morphology, and degree of contrast enhancement[1][3][4].
• Dosing and Safety: Patients received doses ranging from 0.025 mmol/kg to 0.3 mmol/kg, with the recommended dose being 0.05 mmol/kg. The trials showed that ELUCIREM could achieve superior image quality at half the conventional gadolinium dose of other GBCAs. No major safety signals were reported, and adverse reactions were similar to those of other GBCAs[3][4].

Benefits of ELUCIREM

High Relaxivity and Reduced Dose

ELUCIREM stands out due to its high relaxivity, which is twice that of other non-specific GBCAs. This means it can provide high-quality contrast-enhanced images at a significantly lower dose of gadolinium, addressing concerns about gadolinium exposure[3][4].

Improved Image Quality

The drug has been shown to enhance the visualization of lesions with abnormal vascularity in both the CNS and the body. In the PICTURE and PROMISE trials, ELUCIREM demonstrated superiority over unenhanced MRI and non-inferiority to gadobutrol at a full dose, as assessed by three lesion visualization criteria[3][4].

Clinical Applications

ELUCIREM is indicated for use in adults and pediatric patients aged 2 years and older for detecting and visualizing lesions in various parts of the body, including the brain, spine, head and neck, thorax, abdomen, pelvis, and musculoskeletal system. This makes it particularly beneficial for patients requiring multiple MRI scans over time, such as those with oncological or neurological conditions[3][4].

Market Analysis

FDA Approval and Priority Review

The FDA granted ELUCIREM priority review, a designation reserved for drugs that offer significant improvements in safety or effectiveness compared to available therapies. This approval highlights the drug's potential to revolutionize MRI imaging practices[3][4].

Regulatory Review Period

The FDA determined a regulatory review period of 2,443 days for ELUCIREM, with 2,199 days spent in the testing phase and 244 days in the approval phase. This extensive review period underscores the thorough evaluation the drug underwent before approval[2].

Market Positioning

Guerbet, a leader in medical imaging, has positioned ELUCIREM as a next-generation GBCA. The drug's unique properties and the company's long-standing experience in MRI contrast agents are expected to drive market adoption. The classification of ELUCIREM as a Group II agent by the American College of Radiology (ACR), indicating a very low risk of nephrogenic systemic fibrosis, further enhances its market appeal[5].

Market Projections

Adoption and Usage

Given its superior imaging capabilities and reduced gadolinium dose, ELUCIREM is expected to see rapid adoption in clinical settings. The first clinical administration in the United States, which took place in February 2023 at the Hospital of the University of Pennsylvania, sets a positive precedent for its use in real-world scenarios[4].

Competitive Landscape

ELUCIREM enters a market dominated by other GBCAs, but its unique features, such as high relaxivity and lower dosing requirements, are likely to give it a competitive edge. Guerbet's partnership with Bracco, which has also launched a commercial version of gadopiclenol (Vueway), suggests a strong market presence and potential for widespread adoption[3][5].

Future Growth

The demand for advanced MRI contrast agents is expected to grow, driven by the increasing need for precise diagnostic imaging in various medical specialties. ELUCIREM's approval and its demonstrated benefits position it well for significant market growth in the coming years.

Key Takeaways

• High Relaxivity: ELUCIREM has the highest relaxivity among non-specific GBCAs, allowing for high-quality images at half the conventional gadolinium dose.
• Clinical Efficacy: The drug has been shown to improve image quality in both CNS and body lesions, with superior visualization criteria.
• Safety Profile: ELUCIREM has a favorable safety profile, with no major safety signals reported and a very low risk classification by the ACR.
• Market Potential: With FDA approval and priority review, ELUCIREM is poised for rapid adoption and significant market growth.

FAQs

Q: What is ELUCIREM used for?

A: ELUCIREM is used as an MRI contrast agent to detect and visualize lesions with abnormal vascularity in the central nervous system and the body.

Q: What makes ELUCIREM unique?

A: ELUCIREM has the highest relaxivity among non-specific GBCAs, allowing it to provide high-quality images at half the conventional gadolinium dose.

Q: Who can use ELUCIREM?

A: ELUCIREM is indicated for use in adults and pediatric patients aged 2 years and older.

Q: What were the key findings from the clinical trials?

A: The trials showed that ELUCIREM improved image quality, was non-inferior to full-dose gadobutrol, and had a favorable safety profile.

Q: How does ELUCIREM compare to other GBCAs?

A: ELUCIREM requires only half the gadolinium dose of conventional GBCAs and has a very low risk classification for nephrogenic systemic fibrosis.

Sources

1. FDA: Drug Trials Snapshots: ELUCIREM.
2. Federal Register: Determination of Regulatory Review Period for ELUCIREM.
3. PR Newswire: Guerbet Announces U.S. Food and Drug Administration (FDA) Approval of ELUCIREM.
4. Applied Radiology: Celebrating the First Clinical Administration of ELUCIREM.
5. AuntMinnie Europe: Guerbet's MRI contrast agent receives 'very low risk' classification.