JW Pharma applies for phase 3 trial in Taiwan for gout treatment
Jeung-Eun Kim
Dec 19, 2022 (Gmt+09:00)
JW Pharmaceutical headquarters
JW Pharmaceutical announced through its disclosure on Monday that it had applied last Friday for a phase 3 trial for Epaminurad, a gout treatment, with the Taiwan Food and Drug Authority (TFDA).
Epaminurad is an investigational oral uric acid transporter-1 (URAT1) inhibitor that plays an essential role in controlling abnormally high uric acid concentration in the blood.
JW Pharmaceutical is currently conducting phase 3 multinational trials to evaluate the efficacy and safety of Epaminurad versus Febuxostat, a xanthine oxidase inhibitor, targeting 588 gout patients in South Korea, Taiwan, and Europe.
The drug company already obtained approval from Korea's Ministry of Food and Drug Safety on Nov. 25 and will apply to European licensing institutions in the first half of next year.
It plans to conduct the phased trial from December this year to December 2025.
"By proving the effectiveness and safety of Epaminurad on an expanded scale through phase 3 clinical trials, we expect to expand the options for treating gout and hyperuricemia and suggest the possibility of overcoming the current limitations caused by gout and hyperuricemia," said a JW Pharmaceutical official.