Johnson & Johnson Announces Positive Phase 2 Results for FcRn Antibody Nipocalimab in Systemic Lupus Erythematosus, Plans Global Phase 3 Trial

▎Armstrong

On January 6, 2026, Johnson & Johnson announced that the FcRn antibody Nipocalimab achieved positive data in the Phase II clinical trial for systemic lupus erythematosus (SLE), becoming the first FcRn antibody drug with the potential to reduce SLE disease activity. Based on the Phase II clinical data, Johnson & Johnson plans to initiate a Phase III clinical trial of Nipocalimab for the treatment of systemic lupus erythematosus.

The Phase II clinical trial JASMINE enrolled 228 patients, treated for 24 weeks, achieving the SRI-4 endpoint with significant improvement compared to the placebo group. It also met key secondary endpoints and extended exploratory goals, including the potential to reduce steroid use.

On August 1, 2020, Johnson & Johnson acquired Momenta, a biotechnology company, for $6.5 billion, gaining access to its autoimmune R&D pipeline, including Nipocalimab (which was in Phase III clinical trials at the time, with the following pipeline under development).

Summary

Argenx's Efgartigimod is the first marketed FcRn-targeting drug, with sales of $1.2 billion in 2023 and $2.2 billion in 2024. In the first three quarters of this year, sales reached $2.9 billion, and full-year sales are expected to exceed $4 billion. In China, Zai Lab has acquired the rights to Efgartigimod for the Greater China region.