JW Pharmaceutical Completes Final Patient Dosing in Phase 3 Asia Trial of Gout Treatment Epaminurad Across Five Countries

Evaluation of Uric Acid Reduction and Safety Compared to Febuxostat
Final Report Expected by Year-End

JW Pharmaceutical has completed the final patient dosing in the Asia multi-country Phase 3 clinical trial for its gout treatment candidate, Epaminurad.

JW Pharmaceutical Headquarters Building. JW Pharmaceutical

JW Pharmaceutical announced on April 27 that the last patient dosing for the multi-country Phase 3 clinical trial of Epaminurad (code name URC102) was completed in Malaysia on April 23. This clinical trial, which began after receiving Phase 3 IND approval from the Ministry of Food and Drug Safety in 2022, was conducted in five Asian countries: Korea, Taiwan, Thailand, Malaysia, and Singapore. The trial was designed to evaluate the uric acid-lowering effect and safety of Epaminurad compared to the existing treatment, febuxostat.

Epaminurad is an oral drug candidate that selectively inhibits the renal uric acid transporter hURAT1, thereby promoting uric acid excretion. In the previous Phase 2 clinical trial, it met both the primary and secondary efficacy endpoints, and its safety and tolerability were confirmed. During the Phase 3 trial, the U.S. Data Safety Monitoring Board (DSMB) recommended continuing the trial as planned at multiple meetings.

JW Pharmaceutical recently registered a patent for the dosing regimen of Epaminurad with the United States Patent and Trademark Office (USPTO), extending its exclusivity period in the U.S. market from 2029 to 2038. This patent has been registered in 18 countries, including Korea, the United States, Canada, and Australia, and is under review in 11 countries, such as those in Europe, Japan, and China.

The company plans to complete follow-up observation and data analysis and aims to produce a final report by the end of this year.

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