Ligelizumab
Monoclonal antibody
From Wikipedia, the free encyclopedia
Ligelizumab (INN; development code QGE031) is a humanized IgG1 monoclonal antibody designed for the treatment of severe asthma and chronic spontaneous urticaria.[1] It is an anti-IgE that binds to IGHE an acts as an immunomodulator.[2][3] It is delivered as a subcutaneous biologic injection.[4]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | IGHE |
| Clinical data | |
| Other names | QGE031 |
| ATC code |
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| Identifiers | |
| CAS Number | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6534H10000N1716O2038S44 |
| Molar mass | 146612.49 g·mol−1 |
This drug was developed by Novartis Pharma AG. Research funded by Novartis Pharma concluded that Ligelizumab was more effective in treating chronic spontaneous urticaria than omalizumab or placebo.[5][6]
In 2021, the US Food and Drug Administration ligelizumab a breakthrough therapy designation for the treatment of patients with chronic spontaneous urticaria who have an inadequate response to H1-antihistamine treatment.[7]
In December 2021, two phase three clinical trials (PEARL 1 and PEARL 2) of ligelizumab in chronic inducible urticaria failed to show superiority versus omalizumab and were terminated.[8][9][10]
In January 2023, a phase three study of ligelizumab in chronic inducible urticaria was terminated after primary endpoints versus omalizumab 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]
