Ligelizumab (INN; development codeQGE031) is a humanized IgG1 monoclonal antibody designed for the treatment of severe asthma andchronic spontaneous urticaria.[1] It is an anti-IgE that binds toIGHE an acts as animmunomodulator.[2][3] It is delivered as a subcutaneous biologic injection.[4]
This drug was developed byNovartis Pharma AG. Research funded by Novartis Pharma concluded that Ligelizumab was more effective in treating chronic spontaneous urticaria thanomalizumab orplacebo.[5][6]
In December 2021, two phase three clinical trials (PEARL 1 and PEARL 2) of ligelizumab in chronic inducible urticaria failed to show superiority versusomalizumab and were terminated.[8][9][10]
In January 2023, a phase three study of ligelizumab in chronic inducible urticaria was terminated after primary endpoints versusomalizumab were not achieved.[11]
In January 2024, a phase three peanut allergy study for ligelizumab was terminated by Novartis.[12]
As of November 2024, the long-term safety and efficacy of ligelizumab in study participants who have completed a ligelizumab Phase III study in food allergy is under investigation.[13]
^Clinical trial numberNCT02477332 for "A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)" atClinicalTrials.gov
