JW Pharma gets OK for phase 3 clinical trials of URC102 in Taiwan
Ji-Hyun Lee
Aug 18, 2023 (Gmt+09:00)
The headquarters of JW Pharmaceutical in Gwacheon South Korea's JW Pharmaceutical has won approval from Taiwan's Food and Drug Administration (TFDA) to conduct phase 3 clinical trials for its gout treatment, Epaminurad (URC102), the company said on Friday.
Epaminurad, an oral uric acid transporter-1 (URAT1) inhibitor, aims to regulate high uric acid levels in the bloodstream. The upcoming trial will assess the drug's efficacy in reducing uric acid against the control drug Febuxostat, targeting gout patients in Taiwan.
The TFDA had earlier, in March, held off on giving the green light due to issues with the country manufacturing Febuxostat not meeting their licensing standards. JW Pharmaceutical addressed these concerns and reapplied in June.
While the phase 3 clinical trial, set to involve 588 participants, will span five Asian countries, including South Korea and Taiwan, plans to extend the trial to Europe have been shelved.
The firm has also initiated clinical trial applications in Singapore, Thailand, and Malaysia. In South Korea, patient registration began in March following a trial approval in November last year.
Additionally, JW Pharmaceutical is seeking to expand Epaminurad's footprint overseas. Notably, in 2019, they granted China's Simcere Pharmaceutical Group the rights to develop and sell the drug in China, Hong Kong, and Macao.