Efficacy and safety of epaminurad, a potent hURAT1 inhibitor, in patients with gout: a randomized, placebo-controlled, dose-finding study
Authors' conclusion
Epaminurad was effective at reducing sUA levels in patients with gout.
Study context
- Population
- Patients aged 19–70 years with gout and serum urate (sUA) ≥ 0.42 mmol/L, receiving gout prophylaxis and therapeutic lifestyle changesreceived study medication
- Participants
- 169 patients
- Comparison
- Epaminurad 3 mg, 6 mg or 9 mg vs placebo once daily for 12 weeks; febuxostat 80 mg as reference arm
- Primary endpoint
- Proportion of patients with sUA < 0.36 mmol/L
- Follow-up
- Week 4
Methodological detailsmulticentre, double-blind, placebo-controlled, dose-finding, phase 2b, standard-treatment reference arm, Mean adherence > 90% in all groups
- Multicentre
- Double-blind
- Placebo-controlled
- Dose-finding
- Phase 2b
- Standard-treatment reference arm
- Mean adherence > 90% in all groups
Primary result
As reported in the abstract
Proportion with sUA < 0.36 mmol/L
Epaminurad 9 mg vs Placebo: P < 0.0001 · Epaminurad 6 mg vs Placebo: P < 0.0001 · Epaminurad 3 mg vs Placebo: P < 0.0001
Further findings
sUA < 0.30 mmol/L and mean percent and absolute change in sUA · week 4
- Significantly greater in all epaminurad groups vs placebo
Outcomes at weeks 8 and 12
- Consistent with week 4
Safety
Adverse events
- AE rate did not differ between epaminurad groups and placebo; most events mild
Serum creatinine and liver function
- No significant differences between epaminurad groups and placebo
Original publication
Efficacy and safety of epaminurad, a potent hURAT1 inhibitor, in patients with gout: a randomized, placebo-controlled, dose-finding study. Arthritis Res Ther. Published 26 May 2025. doi:10.
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