[Edaily Reporter KIM SAE-MI ] #Inventera Inc. announced on the 24th that it has completed the preclinical trial package for “INV-003,” its next-generation oral magnetic resonance cholangiopancreatography (MRCP) contrast agent candidate, and plans to proceed with domestic and international clinical trials within the year.

MRCP is a non-invasive imaging test based on magnetic resonance imaging (MRI) that examines the pancreatic and bile ducts. It is used for the diagnosis and evaluation of patients suspected of having gallstones, biliary obstruction, cholangitis, acute or chronic pancreatitis, and tumors of the pancreaticobiliary tract. Unlike endoscopic retrograde cholangiopancreatography (ERCP), it is characterized by the ability to visualize the structure of the pancreatic and bile ducts without the insertion of an endoscope.

INV-003 is an iron-based nano-MRI contrast agent currently under development to selectively reduce high signals in the stomach and duodenum during MRCP examinations, thereby producing clearer images of the pancreatic and bile ducts. In conventional MRCP imaging, fluid signals within the gastrointestinal tract can interfere with the interpretation of pancreatic and bile duct images; INV-003 aims to suppress these signals to enhance the visibility of pancreatic and bile duct structures.

Inventera Inc. confirmed the imaging enhancement effects of INV-003 in DAEDONG CORPORATION's large-animal efficacy tests using a porcine model. According to the company, an evaluation by radiologists at Asan Medical Center in Seoul showed that after administration of INV-003, gastrointestinal signals were suppressed, allowing for clearer differentiation of pancreatic and bile duct structures.

Key preclinical studies for safety evaluation have also been completed. In repeated-dose toxicity studies conducted in accordance with GLP standards, no toxicological abnormalities related to the test compound were observed even at doses up to approximately 640 times the expected clinical dose.

Based on the completion of this preclinical package, Inventera Inc. is preparing to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The company aims to submit the U.S. IND application in the third quarter of this year and plans to submit an IND application to the Ministry of Food and Drug Safety (MFDS) in Korea by the end of the year.

This achievement is significant because it marks the advancement of a follow-up pipeline into the clinical phase, following the recent completion of Phase 3 clinical trials for Inventera Inc.’s lead pipeline candidate, “INV-002.” Inventera Inc. is developing multiple nano-MRI contrast agent pipelines based on its nanopharmaceutical platform, “Invinity.”

An Inventera Inc. official stated, “INV-003 is the world’s first oral MRCP contrast agent candidate currently in development,” adding, “Amid growing demand for the early detection and accurate imaging assessment of pancreatic and biliary tract diseases, we will foster it as a key growth driver following our lead pipeline through domestic and international clinical development.”

Meanwhile, INV-003 was selected in 2025 as a preclinical development project by the Korea Drug Development Fund (KDDF).