JW Pharma takes gout drug Epaminurad to Malaysia for phase 3
Ji-Hyun Lee
Jan 15, 2024 (Gmt+09:00)
South Korea's JW Pharmaceutical Corp., announced on Monday that it has received approval from the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for a phase 3 clinical trial of its gout treatment drug, Epaminurad (URC102).
This approval makes Malaysia the fifth Asian country, after South Korea, Taiwan, Thailand and Singapore, to approve a phase 3 clinical trial of Epaminurad.
The phase 3 trial will evaluate the efficacy and safety of Epaminurad versus the comparator drug, febuxostat, in 588 gout patients in the participating countries.
Epaminurad, which is being developed as an oral medication, works by selectively inhibiting the urate transporter, human uric acid transporter-1 (hURAT1), to promote urate excretion, the company explained.
It is effective for hyperuricemia, a condition in which the blood uric acid level is abnormally high, and gout.
In addition to the phase 3 trial, JW Pharmaceutical is also pursuing global technology licensing of Epaminurad.
In 2019, the company licensed the development and marketing rights of Epaminurad in China, Hong Kong, and Macau to Simcere Pharmaceutical in China.