South Korea’s LG Chem has submitted a Phase 3 clinical trial protocol of its investigational gout treatment drug to the Spanish Agency of Medicines and Medical Devices (AEMPS).

The Phase 3 clinical trial is designed to evaluate the safety and efficacy of Tigulixostat, an orally administered small molecule xanthine oxidase (XO) inhibitor, in about 350 patients for six months, the company said on Friday.

Tigulixostat is a non-purine selective XO inhibitor which lowers production of uric acid, the primary cause of gout, a common form of inflammatory arthritis that causes pain and swelling in joints. About 35 million people are affected by this condition worldwide. The company aims to launch the product globally from 2028.

LG Chem filed an NDA for Phase 3 clinical trials of the drug in the United States in August and in China earlier this month.

By Susan Lee

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