Ildong Pharmaceutical Begins Phase 1 Clinical Trial with NASH Treatment Candidate Approved by US FDA

Exterior view of Ildong Pharmaceutical.

[Asia Economy Reporter Lee Gwan-joo] Ildong Pharmaceutical announced on the 1st that it has received approval from the U.S. Food and Drug Administration (FDA) for the Phase 1 clinical trial of the non-alcoholic steatohepatitis (NASH) treatment candidate 'ID119031166M.'

Through the Phase 1 clinical trial, Ildong Pharmaceutical will study the safety, tolerability, and pharmacokinetics of ID119031166M in healthy adult subjects. In particular, the trial, divided into single-dose and multiple-dose studies, will gradually increase the dosage to identify the maximum tolerable dose and the expected effective dose, while also evaluating the dietary impact on the drug.

Ildong Pharmaceutical’s 'ID119031166M' is a NASH treatment candidate that acts as an FXR agonist by binding to and activating the farnesoid X receptor (FXR). FXR is one of the receptors located in the cell nucleus and is known to be involved in liver lipid and glucose metabolism, bile acid synthesis and secretion, and inflammatory responses.

An Ildong Pharmaceutical official stated, “The design of the Phase 1 clinical trial was developed through close collaboration not only with Ildong Pharmaceutical’s R&D headquarters but also with the clinical pharmacology consulting company Aims Bioscience,” adding, “We completed prior consultations with the FDA and smoothly obtained IND approval.” The official further said, “We will focus our efforts on the clinical trial, aiming to complete Phase 1 by the second half of next year.”

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