LG Chem said it is in the final stage of entering the global gout treatment market.

LG Chem applied for a phase 3 clinical trial of Tigulixostat, a self-developed novel gout treatment, to the U.S. Food and Drug Administration on Monday. It marked the first time the company applied for a phase 3 clinical trial, planning to expand its bio business to the U.S. and European markets.

Tigulixostat is an oral gout treatment restraining Xanthine Oxidase manifestation, an enzyme producing uric acid, which is a major cause of gout.

The clinical trial will evaluate the drug’s safety and efficacy through a placebo-controlled comparison experiment on 350 gout patients with hyperuricacidemia from various countries, including the U.S.

In addition, LG chem will sign up for a comparison test with Allopurinol, a first line treatment for hyperuricacidemia gout patients, to the FDA. It is aimed to prove the differentiated efficacy, and long-term use safety by recruiting a large-scale examination group, according to LG Chem.

LG Chem plans to receive item approval as the first-line treatment from the U.S. regulator in 2027 and start global sales in 2028.

“Phase 3 clinical trial of Tigulixostat will become a catalyst for strengthening LG Chem’s novel drug clinical trial, approval, production, and sales capacity,” said Son Ji-woong, head of LG Chem’s Life Science Business Division. “We will bring a turning point in the gout treatment market through a clinical trial strategy for securing global competency and preparation for preemptive commercialization.”

LG Chem found the possibility for novel gout treatment development in phase 2 clinical trial results with rapid and powerful uric acid drop effects and proved its safety to the placebo group.