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PACIFICA PHASE3 ACTIVE n=348
Drug: Vonjo · SOBI
Study Design
DesignRandomized, active-controlled
Randomization2:1
Enrollment348
Duration24 weeks
Treatment Arms
Pacritinib 200 mg BID 200 mg oral twice daily n=232
Physician's choice BAT including ruxolitinib, danazol, hydroxyurea n=116
Primary Endpoints
[{"id":"pac-ep1","name":"SVR >=35% at Week 24","type":"PRIMARY","results":[],"timepoint":"Week 24","description":"Confirmatory trial required by FDA post-accelerated approval. Must demonstrate spleen volume reduction to maintain full approval."}]
Assessment
EXISTENTIAL catalyst for Vonjo. Failure = accelerated approval withdrawal = Vonjo revenue to zero. Success = secured franchise in an underserved niche. ~348 patients, 2:1 randomization. Timing unclear but expected 2026-2027.
Background & Context
Post-marketing commitment for accelerated approval confirmation. Existential for Vonjo franchise.
Data from Supabase · Updated 2026-03-24