JW Pharmaceutical said Friday that Ministry of Food and Drug Safety(MFDS) approved a multi-country phase 3 trial of epaminurad (pipeline name: URC102), a gout treatment.

The drug regulator approved JW Pharmaceutical’s plan to conduct a phase 3 trial of Epaminurad in multiple countries.
The drug regulator approved JW Pharmaceutical’s plan to conduct a phase 3 trial of Epaminurad in multiple countries.

Epaminurad, developed as an oral pill, is a uric acid transporter-1 (URAT1) inhibitor. The company hopes that it could treat gout disease caused by abnormally high uric acid concentration in the blood. 

The company will conduct the phase 3 trial in 588 gout patients in Korea, Taiwan, and Europe, in comparison with febuxostat. 

JW Pharmaceutical plans to apply for the phase 3 trial in Taiwan next month, and in Europe, in the first half of 2023. 

“Incidence of gout is rising but there are many unmet needs of effective gout medicine,” said an official at JW Pharmaceutical, “The company will strive to supply epaminurad worldwide.”  

Epaminurad met the primary and secondary endpoints of the local phase 2b trial, which ended in March. It showed strong safety and drug tolerability, the company said. 

 

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