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TOPLINE:

Epaminurad, a selective human urate transporter 1 inhibitor, was generally safe and well-tolerated and significantly reduced serum urate levels in patients with gout, with higher response rates observed with it at three different doses than with placebo.

METHODOLOGY:

• A randomized, placebo-controlled, phase 2b trial was conducted at 18 centers in South Korea (April 2019-October 2020) to determine the optimal dose of epaminurad and assess its urate-lowering efficacy and safety compared with those of placebo.
• The trial included 169 adult patients with gout (mean age, 48 years; 99% men) who had serum urate levels ≥ 0.42 mmol/L (≥ 7 mg/dL).
• Eligible patients underwent a 4-week screening period with lifestyle changes (dietary measures and exercise therapy), washout of prior treatments, and initiation of gout prophylaxis with colchicine or low-dose nonsteroidal anti-inflammatory drugs.
• Patients were randomly assigned to receive epaminurad at a 3-mg (n = 37), 6-mg (n = 39), or 9-mg (n = 36) dose; reference treatment with 80 mg febuxostat (n = 19); or placebo (n = 38) once daily for 12 weeks.
• The primary efficacy endpoint was the proportion of patients with serum urate levels < 0.36 mmol/L (< 6 mg/dL) at week 4 after treatment initiation. The secondary endpoint included the incidence of gout flares at weeks 4, 8, and 12, along with safety assessments.

TAKEAWAY:

• At week 4, the proportion of patients achieving serum urate levels < 0.36 mmol/L was significantly higher in the epaminurad groups (9 mg: 88.9%, 6 mg: 71.8%, and 3 mg: 54.1%) than in the placebo group (0%; P < .0001 for all). The effect was consistent at weeks 8 and 12.
• The epaminurad groups also showed higher response rates than the placebo group in achieving serum urate levels < 0.30 mmol/L (< 5 mg/dL) at week 4 (for 9 and 6 mg, P < .0001, and for 3 mg, P = .0003) and showed a significant reduction in serum urate levels from baseline, whereas the placebo group did not.
• The incidence of gout flares at week 4 was 5.6% for the 9-mg group and 12.8% for the 6-mg group, not significantly different from that for the placebo group (2.7%), but it was significantly higher for the 3-mg group vs the placebo group (21.6%; P = .0281).
• Treatment-emergent adverse events (TEAEs) were mostly mild in nature, with no significant differences in the incidence of adverse drug reactions or TEAEs between the epaminurad and placebo groups; no serious drug-related adverse events were reported.

IN PRACTICE:

“The results suggest that epaminurad has potential as a treatment for patients with gout,” the study authors wrote.

SOURCE:

The study was led by Jae-Bum Jun, MD, PhD, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea. It was published online on May 26, 2025, in Arthritis Research & Therapy.

LIMITATIONS:

This study did not include a statistical comparison with the febuxostat active control group.

DISCLOSURES:

This study was funded by JW Pharmaceutical Corp. The authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.