-Multinational Phase 3 trials conducted across five Asian countries, including South Korea
-Evaluates serum uric acid reduction efficacy and safety… Clinical Study Report (CSR) expected by the end of the year
April 2026
JW Pharmaceutical announced on the 27th that it has successfully completed the last patient dosing (LPD) in the multinational Phase 3 clinical trial of its gout treatment candidate, 'Epaminurad' (development code: URC102).
Epaminurad is a uricosuric agent featuring a mechanism that selectively inhibits hURAT1 (human uric acid transporter-1). It is an oral novel drug candidate currently under development for hyperuricemia and gout, conditions characterized by abnormally high levels of uric acid in the bloodstream.
Since receiving Investigational New Drug (IND) approval for the multinational Phase 3 trial from the Ministry of Food and Drug Safety (MFDS) in 2022, JW Pharmaceutical has been rigorously conducting clinical trials on gout patients across five Asian countries: South Korea, Taiwan, Thailand, Malaysia, and Singapore. The Phase 3 trial was intricately designed to evaluate Epaminurad's efficacy in reducing serum uric acid levels and its safety profile compared to the existing standard treatment, febuxostat. The final patient dosing was successfully concluded in Malaysia on the 23rd.
Gout is a metabolic disorder that arises when uric acid generated in the body is not smoothly excreted and accumulates. When uric acid in the blood or synovial fluid remains as crystals and deposits in cartilage, periarticular tissues, or subcutaneous tissues, it triggers severe inflammation and pain. There is a particularly pressing medical need for therapeutic options that promote uric acid excretion for patients with 'underexcretion-type' gout. However, the prescription of existing treatments has been heavily restricted due to severe safety concerns regarding kidney and liver functions.
JW Pharmaceutical is developing Epaminurad to effectively address these critical unmet medical needs. In the previously conducted Phase 2 clinical trials, the drug successfully met all primary and secondary efficacy endpoints while robustly confirming its safety and tolerability.
Throughout the Phase 3 trial, the Data Safety Monitoring Board (DSMB), an independent committee that reviews drug safety, consistently recommended continuing the clinical trial as originally planned across multiple review meetings.
Notably, JW Pharmaceutical recently registered a method-of-use (dosage and administration) patent for Epaminurad with the United States Patent and Trademark Office (USPTO). This pivotal registration significantly extended the drug's exclusivity period in the U.S. market from the original 2029 to 2038. This dosage and administration patent is now registered in a total of 18 countries, including South Korea, the U.S., Canada, and Australia, with patent examinations actively underway in 11 additional regions such as Europe, Japan, and China.
Following the completion of the last patient dosing, JW Pharmaceutical plans to conduct comprehensive follow-up observations and data compilation, aiming to release the definitive Clinical Study Report (CSR) by the end of this year.
"With the completion of the last patient dosing in the Phase 3 trial of Epaminurad, we will concentrate our full capabilities on follow-up observations, meticulous data compilation, and detailed analysis, targeting the release of the CSR by the end of the year," a JW Pharmaceutical official stated. "We remain deeply committed to developing Epaminurad into a groundbreaking therapeutic option capable of resolving the significant unmet medical needs in the field of gout treatment."
■ About Gout and Market Size
Gout is a disease experiencing a steady increase in patient numbers, largely propelled by the westernization of dietary habits and corresponding lifestyle changes. According to the Healthcare Big Data Hub provided by the Health Insurance Review & Assessment Service, the number of gout patients in South Korea climbed sharply from 468,083 in 2020 to 553,254 in 2024. In tandem with the surging patient population, the global gout treatment market is expanding rapidly. According to a report by the global market research firm Grand View Research, the global gout treatment market, valued at approximately $2.8 billion in 2024, is projected to grow to an estimated $4.1 billion by 2030.