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Nipocalimab granted FDA fast track designation for SLE
On March 3, 2026, the U.S. Food and Drug Administration (FDA) granted fast track designation to nipocalimab, an investigational immunoselective treatment designed to block FcRn and reduce circulating immunoglobulin G (IgG) antibodies, for the treatment of systemic lupus erythematosus (SLE).1
This designation is supported by positive results from the phase IIb JASMINE (NCT04882878) study, evaluating nipocalimab in 228 patients with active SLE.1 Enrollment for the phase III GARDENIA (NCT07438496) study, evaluating nipocalimab in adult patients with moderate-to-severe SLE, is ongoing.1
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