Our MRI Contrast Agent Pipeline
INV-002
INV-002 is an iron (Fe)-based T1 contrast agent specialized in magnetic resonance arthrography (MRA). On administration into the joint cavity, it allows clearer and safer observation of complex anatomical structures such as ligaments, rotator cuffs tendon, and cartilage, thereby enhancing the diagnostic performance for articular disorders.
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Ready-to-use without the need for dilution, eliminating the risks of contamination and variable contrast concentration.
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Provides a contrast duration four times longer than existing agents, allowing for more flexible scan scheduling.
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Free from the risk of nephrogenic systemic fibrosis (NSF) associated with gadolinium-based contrast agents.
In July 2024, we completed the last patient visit in our Phase 2b clinical trial in Korea. We are now preparing to advance into a Phase 3 trial, as well as initiate a Phase 2b trial in the United States.
Why is a new contrast agent like INV-002 necessary? Accurate diagnosis of articular disorders requires a contrast agent specifically designed for MR Arthrography (MRA). However, to date, no contrast agents have been approved for MRA use in most countries. As a result, medical practitioners have had to rely on the off-label use of high-concentration gadolinium-based agents, which require dilution before use. Such off-label use poses risks, including contamination during dilution and inconsistent contrast agent concentration. Additionally, the short duration of the contrast effect makes it difficult to capture sufficient images during MRI scans. Most concerning, gadolinium—the primary ingredient—has been associated with nephrogenic systemic fibrosis (NSF) and gadolinium retention, which present significant safety concerns.
INV-001
INV-001 is an iron (Fe)-based T1 contrast agent specialized in magnetic resonance lymphangiography (MRL). On administrating intradermally/subcutaneously, it specifically visualizes the lymphatic system without venous contamination, enabling accurate diagnosis of lymphatic diseases like lymphedema.
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With a mechanism of action that selectively images lymphatic vessels, non-clinical trials on small and large animals have shown clear visualization of microlymphatic vessels as small as 0.3 mm without venous contamination.
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If successfully launching, it is expected to be the world's first-in-class "approved" MRL-specific contrast agent.
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Avoids the risk of nephrogenic systemic fibrosis (NSF) by not using gadolinium.
In May 2023, we obtained IND approval from the Ministry of Food and Drug Safety (MFDS) for the Phase 1/2a clinical trial, and we are currently conducting the trial at leading university hospital in Korea.
Why is a new contrast agent like INV-001 necessary? Magnetic resonance lymphangiography (MRL) is one of the most promising imaging techniques for assessing the lymphatic system (LS) due to its superior soft-tissue contrast, lack of radiation, and no penetration depth limitations. However, current MRI contrast agents, particularly gadolinium-based agents (GBCAs), suffer from limitations in resolution, specificity, and safety, hindering accurate diagnosis and treatment of lymphatic disorders such as breast cancer-related lymphedema (BCRL) and peripheral lymphedema. Venous contamination is one of the critical hurdles for MRL using GBCAs. There is a pressing need for innovative solutions that can overcome these challenges and provide highly accurate structural and functional information of the LS.