In late-breaking phase 3 results, pozdeutinurad lowered serum urate through 12 months in patients with uncontrolled gout

1. Pozdeutinurad reduced serum urate (SU) below 6 mg/dL at month 6 in 69.2% and 56.6% of patients receiving 75 mg and 50 mg, respectively, versus 8.1% with placebo (both p<0.0001).

2. Treatment-emergent adverse events (TEAEs) occurred in 60.7%, 61.7% and 60.9% of patients receiving pozdeutinurad 75 mg, 50 mg and placebo, respectively.

Evidence Rating Level: 2 (Good)

2MM Brief: Gout is characterized by monosodium urate crystal deposition that can cause recurrent flares and tissue damage, while outcomes remain poorly optimized for some patients. Sobi announced late-breaking results from REDUCE-2, a phase 3, double-blind, randomized, placebo-controlled study of 811 patients with gout. Participants received once-daily oral pozdeutinurad 75 mg, pozdeutinurad 50 mg or placebo, with outcomes assessed through 12 months. Pozdeutinurad is an investigational, highly selective urate transporter 1 (URAT1) inhibitor. The primary endpoint was the proportion of patients achieving SU below 6 mg/dL at month 6. This occurred in 69.2% of patients receiving 75 mg and 56.6% receiving 50 mg, compared with 8.1% receiving placebo; both comparisons had p<0.0001. SU reductions were observed as early as month 1 and were sustained through month 12. At each assessment during the 12-month period, a greater proportion of patients receiving either pozdeutinurad dose achieved SU levels below 6, 5, 4 and 3 mg/dL than those receiving placebo. Treatment-emergent adverse events (TEAEs) occurred in 60.7%, 61.7% and 60.9% of patients receiving pozdeutinurad 75 mg, 50 mg and placebo, respectively. The company reported that the findings were scheduled for presentation at ACR Convergence 2026; the full results have not been peer reviewed. The release did not provide confidence intervals or report clinical outcomes such as flares, tophi or joint damage. As late-breaking results from a single study, these findings suggest that pozdeutinurad lowered SU over 12 months, but further peer-reviewed evidence is needed to clarify its clinical role in uncontrolled gout.

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