Late-breaking data presented at ACR Convergence 2026 show that investigational URAT1 inhibitor pozdeutinurad achieved significant and sustained serum urate reductions over 12 months, with more patients reaching target urate levels compared with placebo.
Sobi, a global biopharmaceutical company, announced positive late-breaking results from the pivotal Phase 3 REDUCE-2 study evaluating pozdeutinurad (AR882), an investigational once-daily oral, highly selective urate transporter 1 (URAT1) inhibitor for patients with uncontrolled gout.
The findings, presented at the American College of Rheumatology (ACR) Convergence 2026, demonstrated clinically meaningful and durable reductions in serum urate (SU) levels through 12 months. Significantly more patients receiving pozdeutinurad achieved target SU levels compared with placebo, while the treatment demonstrated a safety profile generally comparable to placebo.
Phase 3 REDUCE-2 Study: Key Findings
The global Phase 3 REDUCE-2 study enrolled 811 patients with gout, who were randomised to receive pozdeutinurad 75 mg, pozdeutinurad 50 mg or placebo.
The study met its primary endpoint, demonstrating that a significantly higher proportion of patients treated with pozdeutinurad achieved serum urate levels below 6 mg/dL at Month 6.
Primary Endpoint Results at Month 6:
|
Treatment Group |
Patients Achieving SU Below 6 mg/dL |
|---|---|
|
Pozdeutinurad 75 mg |
69.2% |
|
Pozdeutinurad 50 mg |
56.6% |
|
Placebo |
8.1% |
*Both pozdeutinurad doses demonstrated statistically significant improvements compared with placebo (p is a global biopharmaceutical company focused on developing innovative treatments for people living with rare diseases.
The company has approximately 2,000 employees across Europe, North America, the Middle East, Asia and Australia. In 2025, Sobi reported revenue of SEK 28 billion.
Conclusion
The positive Phase 3 REDUCE-2 results highlight the potential of pozdeutinurad as a next-generation oral treatment for uncontrolled gout. Its sustained serum urate-lowering effects, achievement of multiple urate targets and comparable overall adverse-event rates support further clinical development.
The findings could represent an important step towards expanding treatment options for patients who remain inadequately controlled with existing gout therapies. Pozdeutinurad remains investigational, and further regulatory evaluation will be required before it can become an approved treatment.
