JW Pharmaceutical has reported positive results from a multinational Phase 3 trial of its gout drug candidate epaminurad (code name URC102), with the 6mg dose demonstrating statistically superior efficacy in lowering blood uric acid levels compared with febuxostat, a widely used standard treatment.
The trial involved 612 gout patients at 52 medical institutions across South Korea, Taiwan, Thailand, Malaysia and Singapore. It evaluated the efficacy and safety of epaminurad at 6mg and 9mg against febuxostat at 40mg and 80mg in a randomized, double-blind, active-controlled study.
The primary endpoint was the proportion of patients who maintained serum uric acid (sUA) levels below 6mg/dL during the final three measurements of the main treatment period. The rate was 50.0% in the epaminurad 6mg group, compared with 38.3% in the febuxostat 40mg group.
The difference between the two groups was 12.0 percentage points, with a 95% confidence interval of 1.26 to 22.6. Epaminurad met the predefined non-inferiority criterion and also demonstrated statistical superiority over febuxostat 40mg.
The drug also showed a safety profile comparable to febuxostat. No significant differences were observed in treatment-emergent adverse events, adverse drug reactions, serious adverse events or other key safety measures, and no drug-related deaths were reported during the trial.
The 9mg dose, however, did not meet the statistical non-inferiority criterion against febuxostat 80mg. The proportion of patients achieving sUA levels below 6mg/dL was 59.6% for epaminurad 9mg and 63.3% for febuxostat 80mg. JW Pharmaceutical plans to further analyze the data and evaluate the potential use of the higher dose in specific patient populations.
Industry observers say the results could strengthen epaminurad’s prospects in the Korean gout market, where febuxostat-based treatments currently dominate. According to UBIST, the domestic gout treatment market was worth about 41.1 billion won ($30 million) in 2025, with febuxostat products accounting for approximately 84.4% of the market. Febuxostat 40mg alone generated about 26 billion won in prescriptions.
Epaminurad is an oral uricosuric agent that selectively inhibits hURAT1, a uric acid transporter involved in the reabsorption of uric acid in the kidneys. By blocking reabsorption, the drug promotes uric acid excretion through the urine.
JW Pharmaceutical plans to file for Korean regulatory approval in 2027. Epaminurad has been selected for a pilot program under the Ministry of Food and Drug Safety’s initiative to streamline new drug approval and review procedures, and the company completed two pre-NDA meetings with the regulator in July.
The company is also pursuing licensing and other partnerships to support the drug’s entry into global markets. The global gout treatment market is projected to grow from approximately $2.8 billion in 2024 to $4.1 billion by 2030, according to Grand View Research.
