JW Pharmaceutical Gets Approval for Phase 3 Clinical Trials in Taiwan

On Aug. 22, JW Pharmaceutical announced that it has received approval for the Phase 3 clinical trial plan (IND) of the gout drug “Epanewrad” (code name URC102) from the Taiwan Food and Drug Administration (TFDA).

Epanewrad, which JW Pharmaceutical is developing as an oral medication, is a uric acid excretion promoter that inhibits the URAT1 (uric acid transporter-1) mechanism. It is a promising new drug candidate for gout caused by abnormally high concentrations of uric acid in the blood.

Following IND approval, JW Pharmaceutical will evaluate the efficacy of the reduction of uric acid in the blood and safety of Epanewrad compared to another gout medication, Febuxostat, with gout patients in Taiwan.

A total of 588 gout patients from five Asian countries, including Korea, will participate in phase 3 clinical trial for Epanewrad. In preparation, JW Pharmaceutical has applied for IND in Singapore and Thailand in July, and also to Malaysian health authorities in August.

While advancing with the phase 3 trial for Epanewrad centered in Asia, JW Pharmaceutical is also promoting global technology exports. In 2019, it exported the development and sales rights of the drug for China, Hong Kong, and Macao to China’s Simcere Pharmaceutical.

An official from JW Pharmaceutical said, “This approval in Taiwan signifies that our Phase 3 protocol for Epanewrad meets rigorous international standards,” adding, “Considering the significant unmet demand in the global gout drug market, we aim to develop Epanewrad as our top new drug.”