JW Pharmaceutical’s Gout Drug Candidate Outperforms Febuxostat in Phase 3 Trial

JW Pharmaceutical announced favorable outcomes from a global Phase 3 trial of its novel gout medication, epaminurad (code name URC102), exceeding expectations for efficacy in reducing blood uric acid levels compared to the standard treatment febuxostat. The trial, conducted with 612 patients across five countries, assessed epaminurad at 6mg and 9mg doses against febuxostat at 40mg and 80mg in a randomized, double-blind, active-controlled study.

The primary goal was to measure the percentage of patients maintaining serum uric acid levels below 6mg/dL at the final three measurements. Results showed epaminurad 6mg achieved this in 50.0% of patients, compared to 38.3% on febuxostat 40mg, a 12.0 percentage point difference within a 95% confidence interval of 1.26 to 22.6. Notably, epaminurad met the non-inferiority criterion and displayed statistical superiority over febuxostat 40mg.

Safety profiles were comparable, with no significant differences in adverse events or safety measures, and no drug-related deaths. However, the 9mg dose failed to meet the non-inferiority criterion against febuxostat 80mg, with 59.6% of patients achieving target serum uric acid levels versus 63.3% on febuxostat 80mg. JW Pharmaceutical intends to further analyze data and explore potential uses of the higher dose for specific patient groups.

The Korean gout treatment market, valued at 41.1 billion won in 2025, is dominated by febuxostat, which accounted for around 84.4% of prescriptions. Epaminurad works by inhibiting hURAT1, a uric acid transporter, promoting its excretion through urine. JW Pharmaceutical plans to seek Korean regulatory approval by 2027 and has already secured a pilot program for streamlined approval procedures.

Additionally, the company is pursuing licensing and partnerships for global market entry. With the global gout treatment market projected to expand from $2.8 billion in 2024 to $4.1 billion by 2030, according to Grand View Research, JW Pharmaceutical's promising Phase 3 results could significantly bolster epaminurad's prospects in the competitive gout treatment landscape.