Ligelizumab

Ligelizumab

Monoclonal antibody
Type	Whole antibody
Source	Humanized (from mouse)
Target	IGHE
Clinical data
Other names	QGE031
ATC code	none
Identifiers
CAS Number	1322627-61-1
ChemSpider	none
UNII	L8LE0L691T
KEGG	D11761
Chemical and physical data
Formula	C6534H10000N1716O2038S44
Molar mass	146612.49 g·mol^−1

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]

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]

References

1. Novartis Pharma AG (29 October 2014). "Ligelizumab" (PDF). Statement On A Nonproprietary Name Adopted By The USAN Council. American Medical Association.
2. "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 107" (PDF). WHO Drug Information. 26 (2). 2012. Archived (PDF) from the original on 2016-03-04. Retrieved 2020-10-05.
3. Kocatürk E, Maurer M, Metz M, Grattan C (2017-01-10). "Looking forward to new targeted treatments for chronic spontaneous urticaria". Clinical and Translational Allergy. 7: 1. doi:10.1186/s13601-016-0139-2. PMC 5223554. PMID 28078079.
4. "Novartis Ends Phase III Peanut Allergy Trial in Another Flop for Potential Xolair Successor". BioSpace. 2024-01-18. Retrieved 2024-11-29.
5. Maurer M, Giménez-Arnau AM, Sussman G, Metz M, Baker DR, Bauer A, et al. (October 2019). "Ligelizumab for Chronic Spontaneous Urticaria". The New England Journal of Medicine. 381 (14): 1321–1332. doi:10.1056/NEJMoa1900408. hdl:10230/43837. PMID 31577874.
6. Clinical trial number NCT02477332 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)" at ClinicalTrials.gov
7. Parsons, Lucy (2021-01-15). "US breakthrough designation for ligelizumab in chronic spontaneous urticaria - PharmaTimes". pharmatimes.com. Archived from the original on 2023-06-03. Retrieved 2024-11-29.
8. Taylor, Nick Paul (2021-12-20). "Novartis suffers shock setback as Xolair successor fails phase 3 | Fierce Biotech". www.fiercebiotech.com. Retrieved 2024-11-29.
9. Novartis Pharmaceuticals (2023-07-20). A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines (Report). clinicaltrials.gov. Archived from the original on 2024-10-09. Retrieved 2024-11-29.
10. Novartis Pharmaceuticals (2024-02-26). A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines (Report). clinicaltrials.gov. Archived from the original on 2024-10-09. Retrieved 2024-11-29.
11. Novartis Pharmaceuticals (2024-06-14). A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines (Report). clinicaltrials.gov. Archived from the original on 2024-05-15. Retrieved 2024-11-29.
12. Novartis Pharmaceuticals (2024-09-13). A 52 Week, Multi-center, Randomized, Double-blind Placebo-controlled Study to Assess the Clinical Efficacy and Safety of Ligelizumab (QGE031) in Decreasing the Sensitivity to Peanuts in Patients With Peanut Allergy (Report). clinicaltrials.gov.
13. Novartis Pharmaceuticals (2024-11-14). A Three-year, Multi-center, Double-blind, Extension Study to Evaluate the Long-term Safety and Efficacy of Ligelizumab in Patients Who Completed Ligelizumab's Phase III Studies in Food Allergy (Report). clinicaltrials.gov.