LG Chem Applies for Phase 3 Clinical Trial of Gout Drug 'Tigulixostat' with US FDA

[Asia Economy Reporter Lee Gwan-joo] LG Chem is officially entering the final clinical stage to enter the global gout treatment market.

On the 1st, LG Chem announced that it has submitted a clinical phase 3 trial plan for its self-developed gout new drug 'Tigulixostat' to the U.S. Food and Drug Administration (FDA).

This clinical trial is a placebo-controlled comparative study, and LG Chem plans to evaluate the efficacy and safety of the drug at 6 months of administration in 350 adult gout patients with hyperuricemia from multiple countries including the United States. The primary endpoint is set as the proportion of patients reaching a serum uric acid level of 6 mg/dL at 6 months.

In addition, LG Chem plans to submit an additional application to the FDA for a comparative trial with 'Alopurinol,' the first-line treatment ingredient for hyperuricemia gout patients.

Tigulixostat is a once-daily oral gout treatment that inhibits the expression of the enzyme 'Xanthine Oxidase (XO),' which produces uric acid, the main cause of gout. In the U.S. phase 2 clinical trial, which set a challenging primary endpoint (achievement rate of serum uric acid level below 5 mg/dL), it confirmed the possibility of developing a differentiated new drug with a rapid and strong uric acid-lowering effect compared to existing treatments, and demonstrated safety at a level similar to the placebo group.

LG Chem's strategy is to prove differentiated efficacy and long-term safety through recruitment of a large-scale global trial group. Afterwards, it plans to obtain FDA approval as a first-line treatment in 2027 and begin global sales from 2028.

Son Ji-woong, head of LG Chem's Life Sciences Business Division, said, "The global phase 3 trial of Tigulixostat will be a catalyst to further strengthen LG Chem's capabilities in new drug clinical trials, approval, production, and sales," adding, "We will create a new turning point in the gout treatment market through a clinical strategy capable of securing global competitiveness and proactive commercialization preparation."

Meanwhile, the global gout treatment market is expected to expand from 3 trillion won (2.6 billion dollars) in 2019 to 5 trillion won (4.3 billion dollars) in 2027 due to population aging and an increase in obese populations. Currently, there are 35 million diagnosed gout patients worldwide, with an estimated 10 million and 14 million patients in the United States and China, respectively.

This content was produced with the assistance of AI translation services.