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REDUCE-1 PHASE3 ACTIVE n=750
Drug: Pozdeutinurad · SOBI
Study Design
Design12-month, randomized, double-blind, placebo-controlled
Randomization1:1:1
BlindingDouble-blind
Enrollment750
Duration52 weeks
Treatment Arms
Pozdeutinurad 75 mg 75 mg oral once daily n=250
Pozdeutinurad 50 mg 50 mg oral once daily n=250
Placebo Placebo oral once daily n=250
Primary Endpoints
[{"id":"red1-ep1","name":"sUA <6 mg/dL at Month 6","type":"PRIMARY","unit":"%","results":[],"timepoint":"Month 6","description":"Same primary endpoint as REDUCE-2. Replication needed for regulatory filing."}]
Assessment
REDUCE-1 data Q4 2026. If REDUCE-2 (Q2) is positive, REDUCE-1 provides replication. If REDUCE-2 negative, REDUCE-1 is last chance. Filing expected H1 2027 if both positive.
Background & Context
First of two pivotal Phase 3 trials. Fully enrolled July 2025. Data expected Q4 2026.
Data from Supabase · Updated 2026-03-24