Swedish Orphan Biovitrum (STO: SOBI) reported that both doses of pozdeutinurad met the primary endpoint in the Phase III REDUCE 2 study, with 69.2% of patients on the 75 mg dose achieving a serum uric acid level below 6 mg/dL at six months compared with 8.1% on placebo — a result that positions the oral URAT1 inhibitor as a potential option for the large subset of gout patients who fail or inadequately respond to existing urate-lowering therapies.
The REDUCE 2 study (NCT06439602) is a 12-month, randomized, double-blind, placebo-controlled trial that enrolled 811 patients globally, the majority of whom were inadequate responders to standard urate-lowering therapies. Patients were assigned to pozdeutinurad 50 mg, 75 mg, or placebo, each administered once daily. The primary endpoint — the proportion of patients achieving serum uric acid below 6 mg/dL at month six — was met by both active doses, with the 75 mg arm reaching 69.2% versus 8.1% for placebo. The 50 mg arm also met the primary endpoint, though the exact responder rate was not disclosed in the topline release. Sobi described the safety profile as consistent with earlier Phase II studies, with pozdeutinurad overall well tolerated; no specific adverse event rates or discontinuation data were provided. Full results, including 12-month data and secondary endpoints, are expected at a scientific congress in Q4 2026.
Competitive context
Pozdeutinurad works by selectively inhibiting URAT1, the renal proximal tubule transporter responsible for urate reabsorption, thereby increasing urinary uric acid excretion and lowering serum urate. The selective URAT1 inhibitor class has been largely absent from the US market since AstraZeneca's Zurampic (lesinurad) was voluntarily withdrawn in 2019 for commercial reasons, despite retaining its efficacy and safety profile. The dominant oral urate-lowering options — allopurinol and Takeda's Uloric (febuxostat) — act through xanthine oxidase inhibition, a different mechanism, and a meaningful proportion of patients on these agents fail to reach the target serum uric acid threshold. Febuxostat carries an additional constraint in the form of a boxed warning for cardiovascular mortality risk added in 2019, limiting its use in higher-risk patients. For refractory disease, Amgen's Krystexxa (pegloticase) remains the only approved option, but its requirement for biweekly IV infusion and immunogenicity burden restrict its use.