Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1152 |
| INN | Ligelizumab |
| Status | Terminated |
| Drug code(s) | QGE031 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IgE |
| Indications of clinical studies | Chronic Inducible Urticaria, Peanut allergy, Chronic Spontaneous Urticaria, Allergy, Asthma, Atopic Dermatitis, Bullous Pemphigoid |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | January 01, 2009 |
| Start of Phase 2 | January 15, 2012 |
| Start of Phase 3 | October 17, 2018 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Tanox |
| Licensee/Partner | Novartis |
| Comments about company or candidate | Oct 2024: NCT04984876 Phase 3 in peanut allergy terminated by sponsor; no ongoing studies Clinical development for Chronic spontaneous urticaria and Chronic inducible urticaria have been discontinued; the phase 3 study for Peanut allergy (NCT04984876) is not listed anymore on Novartis website; In Novartis pipeline there is only Food allergy indication and there is only 1 clinical study listed on Novartis website: the phase 3 trial for Food Allergy (NCT05678959). Regulatory submission is not expected until 2026. Dec 2021: Novartis announced top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU), which showed that the studies met their primary endpoints of superiority for ligelizumab versus placebo at Week 12, but not versus omalizumab. BLA planned for 2022: https://www.novartis.com/sites/www.novartis.com/files/q2-2021-investor-presentation.pdf Jan 2021: Novartis announced that the U.S. Food and Drug Administration (FDA) has granted ligelizumab (QGE031) Breakthrough Therapy designation for the treatment of chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU), in patients who have an inadequate response to H1-antihistamine treatment. Dec 2019: Novartis plans regulatory submissions for ligelizumab in 2021. NCT03907878 Phase 3 study in Chronic Spontaneous Urticaria patients started recruiting on April 12, 2019; Phase 2 Primary results: Presented at EAACI 2018, EADV 2018, and GUF 2018; manuscript submitted to NEJM Q1-2019. NCT03580369 Phase 3 study in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines started in Oct 2018; NCT03580356 Phase 3 study started recruiting in Oct 2018. One Phase 2 study (NCT02649218) recruiting as of Jan 2017. Several Phase 2 studies sponsored by Novartis recruiting as of Feb 2014; NCT02075008 Phase 2 in allergic asthma due to start in March 2014; start date of first-in-humans study published in Clinical & Experimental Allergy 2014., 44 : 1371–1385 |
| Full address of company | Houston, Texas, United States North America United States of America https://www.crunchbase.com/organization/tanox-inc |
Binding of ligelizumab to IgE in a 2:1 stoichiometry induces an extended and twofold symmetrical conformation of IgE, which retains a rigid Fab-Fc architecture. Analyses of effector cell activation revealed that ligelizumab inhibits IgE binding without displacing receptor-bound IgE. Together with an interference of CD23 binding, the data underline a functional activity similar to omalizumab. https://doi.org/10.1111/all.14222
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |