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Journal of Allergy and Clinical Immunology

Phase 1b/2 Trial of Navenibart for Hereditary Angioedema

Banerji A, Craig T, Sitz K, et al

This phase 1b/2, global, dose-ranging proof-of-concept trial evaluated the safety, pharmacologic profile, and efficacy of navenibart, a long-acting anti–plasma kallikrein monoclonal antibody, in adults with hereditary angioedema due to C1 inhibitor deficiency. Navenibart was well tolerated with no serious treatment-related adverse events and produced substantial, rapid reductions in HAE attack rates (≈86% mean reduction) along with improvements in quality of life. These results support its potential as an effective long-acting prophylactic therapy, enabling dosing intervals of every 3 to 6 months.

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