Celltrion says FDA clears Phase 3 trial plan for Zymfentra in rheumatoid arthritis
Bitget2026/09/23 05:50- Celltrion secured FDA clearance to start a Phase 3 U.S. trial of subcutaneous infliximab CT-P13 SC (Zymfentra) in rheumatoid arthritis.
- Study targets 296 patients, evaluates superiority versus placebo on ACR50 response at week 12, includes 52 weeks of treatment.
- FDA filing dated July 24, 2026; authorization confirmed Sept. 23, 2026.
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