LG Chem announced on August 21 that it has submitted a clinical trial protocol for its new drug candidate "Tigulixostat" for the treatment of gout to the Italian regulatory authorities.
This is a global Phase 3 clinical trial to evaluate the efficacy and safety of Tigulixostat in lowering blood uric acid in patients with hyperuricemic gout.
The Phase 3 study will evaluate the efficacy of Tigulixostat compared to the active control, allopurinol, as a treatment for gout over a 12-month period.
The study is expected to enroll more than 2,600 patients, including in the United States. The trial will be randomized, double-blind, active and placebo-controlled.
"We have submitted the clinical trial plan for Tigulixostat to many countries other than the United States to conduct clinical trials," said an official from LG Chem. "We expect to improve patient compliance and convenience with this once-daily oral gout treatment with rapid onset of action."
