Multinational study in five Asian countries compares epaminurad with febuxostat
Data analysis underway, top-line results targeted by year-end
JW Tower, headquarters of JW Pharmaceutical in Gwacheon, Gyeonggi Province, where the company oversees research and development of new drug candidates including its investigational gout treatment epaminurad.
JW Pharmaceutical announced on the 27th that it completed dosing the last patient in a multinational phase 3 clinical trial of its oral gout treatment candidate epaminurad (code name URC102). The study enrolled gout patients across five Asian countries: Korea, Taiwan, Thailand, Malaysia, and Singapore, under an investigational new drug approval granted by Korea’s Ministry of Food and Drug Safety in 2022.
The phase 3 trial evaluates epaminurad’s efficacy in lowering blood uric acid levels and its safety compared with febuxostat, a standard therapy. Epaminurad selectively inhibits human uric acid transporter‑1 (hURAT1), promoting renal excretion of uric acid. It is being developed as a once‑daily oral drug for patients with hyperuricemia and gout caused by under‑excretion. In a late-phase 2b trial in Korea, the candidate met primary and secondary endpoints and showed favorable safety and tolerability.
Gout is a metabolic disease that occurs when uric acid is not adequately eliminated, leading to its accumulation in the blood and joint fluid and the formation of crystals that cause inflammation and pain. For patients with excretion‑impaired gout, there is significant unmet demand for uricosuric therapies because existing drugs raise concerns about kidney and liver safety and are often prescribed cautiously. During the current phase 3 program, an independent US Data Safety Monitoring Board has reviewed interim safety data several times and consistently recommended continuing the trial as planned.
JW Pharmaceutical has also strengthened the intellectual property position of epaminurad. The company recently registered a new US patent covering the drug’s dosing regimen, extending its expected US market exclusivity from 2029 to 2038. The same patent has been granted in 18 countries, including Korea, the United States, Canada, and Australia, and is under review in 11 additional markets, including Europe, Japan, and China.
After completing the last patient dosing on April 23 in Malaysia, JW Pharmaceutical plans to follow up with observation, data cleaning, and detailed analyses to issue a results report by year-end. A company official said JW will focus on developing epaminurad as a new treatment option to address unmet medical needs in gout, while also pursuing potential global licensing for the drug.
By Min Byung-kwun, KDFN
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