Table of ContentsView AllTable of ContentsHow Ligelizumab WorksStudies and Clinical TrialsSide EffectsIs Ligelizumab Available?Is Ligelizumab FDA Approved?Frequently Asked Questions
Table of ContentsView All
View All
Table of Contents
How Ligelizumab Works
Studies and Clinical Trials
Side Effects
Is Ligelizumab Available?
Is Ligelizumab FDA Approved?
Frequently Asked Questions
Ligelizumabis a next-generation monoclonal anti-immunoglobulin E (IgE)antibody that shows promise for treating chronic hives that arise spontaneously.
Sporadic hives that occur often, last anywhere from 30 minutes to 24 hours, and flare up unpredictably are called chronic spontaneousurticaria(CSU). Another term for CSU is chronic idiopathic urticaria (CIU). Chronic hives last for more than six weeks.
This article provides an overview of ligelizumab and explains why this drug is being developed for the treatment of CSU. Read on to learn more about how this IgE-blocking antibody works, what it’s designed to treat, potential side effects, and more.
Guido Mieth / Getty Images
As an IgE antagonist, ligelizumab binds to inflammation-inducing IgE in the bloodstream and blocks its ability to trigger an inflammatory process that causes itchy welts (also called wheals) to flare up on the skin. Compared to Xolair (omalizumab)—which is another IgE antagonist for treating CSU—initial studies suggest that ligelizumab (QGE031) provides greater and longer-lasting suppression of IgE.
Although omalizumab shows therapeutic efficacy for treatingsevere asthmaand CSU, it has limitations, and Novartis wants to develop a better treatment option for chronic hives.
Over the past few years, Novartis has been conducting clinical trials on a next-generation anti-IgE monoclonal antibody (ligelizumab; QGE031), which they hope will overcome some of omalizumab’s limitations.
A Phase 2b clinical trial published inThe New England Journal of Medicineon Oct. 3, 2019, found that more patients with CSU were completely symptom-free after taking ligelizumab when compared to those taking Xolair.
Another study published inNature Communicationson Jan. 8, 2020, found that ligelizumab can bind to IgE with an 88-fold higher affinity than omalizumab and has the potential to be more effective at treating CSU than omalizumab.
A one-year extension study of Phase 2 clinical trials published on Nov. 13, 2021, in the peer-reviewed journalAllergyconfirmed the long-term safety profile of (a 240-milligram dose of) ligelizumab in patients with CSU.
However, in December 2021, Novartis got some bad news when the preliminary results of Phase 3 studies showed that, after a 12-week treatment, ligelizumab succeeded at reducing CSU symptoms but failed to work better than the existing FDA-approved omalizumab treatment.
Other research published in March 2021 related to the treatment of severe asthma suggests that ligelizumab works well but doesn’t work better than omalizumab.
In a December 2021 news release, Novartis said that all of their final Phase 3 data regarding ligelizumab as a first-line treatment for CSU will become publicly available when their clinical trials are completed.
On Jan. 14, 2021, the FDA granted ligelizumab for CSU its Breakthrough Therapy designation for patients who have an inadequate response to H1-antihistamine treatments.
Breakthrough therapies expedite the development and review of new drugs that have the potential to offer a substantial improvement over existing therapies.Breakthrough therapies show potential but aren’t a sure thing and don’t get FDA approval until Phase 3 trials are complete. Because ligelizumab is still in Phase 3 clinical trials, it isn’t available yet.
Ligelizumab Could Be Available SoonAlthough ligelizumab isn’t available yet, Phase 3 clinical trials are complete, and the drug could be available sometime in the near future.
Ligelizumab Could Be Available Soon
Although ligelizumab isn’t available yet, Phase 3 clinical trials are complete, and the drug could be available sometime in the near future.
Summary
A Word From Verywell
Living with CSU disrupts quality of life and makes it hard to sleep. One of the most frustrating things about CSU is that it’s hard to identify what causes these hives to flare up. The good news is that pharmaceutical advances using humanized monoclonal antibodies show promise for reducing the burden of this skin disorder, improving quality of life, and making it easier to sleep.
Even if ligelizumab (QGE031) doesn’t exceed the performance of omalizumab in Phase 3 trials, this existing FDA-approved anti-IgE treatment for CSU works well for many patients.
Ligelizumab is a biologic drug. It’s a humanized monoclonal antibody that’s derived from non-human living organisms.Learn MoreWhat Are Biologic Treatments?
Ligelizumab is a biologic drug. It’s a humanized monoclonal antibody that’s derived from non-human living organisms.
Learn MoreWhat Are Biologic Treatments?
Ligelizumab is an injectable drug that is administered subcutaneously via injection.
Learn MoreWhat Is the Purpose of Clinical Trials?
15 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Kolkhir P, Altrichter S, Munoz M, Hawro T, Maurer M.New treatments for chronic urticaria.Annals of Allergy, Asthma & Immunology. 2020;124(1):2-12. doi:10.1016/j.anai.2019.08.014Novartis.Novartis provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU).Arm JP, Bottoli I, Skerjanec A, et al.Pharmacokinetics, pharmacodynamics and safety of QGE 031 (Ligelizumab), a novel high‐affinity anti‐IgE antibody, in atopic subjects.Clin Exp Allergy. 2014;44(11):1371-1385 doi:10.1111/cea.12400van den Elzen MT, van Os-Medendorp H, van den Brink I, et al.Effectiveness and safety of antihistamines up to fourfold or higher in treatment of chronic spontaneous urticaria.Clin Transl Allergy. 2017;7(1):4. doi:10.1186/s13601-017-0141-3Arm JP, Bottoli I, Skerjanec A, et al.Pharmacokinetics, pharmacodynamics and safety of QGE 031 (Ligelizumab), a novel high‐affinity anti‐IgE antibody, in atopic subjects.Clin Exp Allergy. 2014;44(11):1371-1385. doi:10.1111/cea.12400Incorvaia C, Mauro M, Russello M, et al.Omalizumab, an anti-immunoglobulin E antibody: state of the art.DDDT. Published online February 2014:197. doi:10.2147/DDDT.S49409Maurer M, Giménez-Arnau AM, Sussman G, et al.Ligelizumab for chronic spontaneous urticaria.N Engl J Med. 2019;381(14):1321-1332. doi:10.1056/NEJMoa1900408Gasser P, Tarchevskaya SS, Guntern P, et al.The mechanistic and functional profile of the therapeutic anti-IgE antibody ligelizumab differs from omalizumab.Nat Commun. 2020;11(1):165. doi:10.1038/s41467-019-13815-wMaurer M, Giménez‐Arnau A, Bernstein JA, et al.Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one‐year extension study.Allergy. 2022;77(7):2175-2184. doi:10.1111/all.15175NIH. ClinicalTrials[dot]gov.A Phase III study of efficacy and safety of ligelizumab in the treatment of CSU in adolescents and adults inadequately controlled with H1-antihistamines.Trischler J, Bottoli I, Janocha R, et al.Ligelizumab treatment for severe asthma: learnings from the clinical development programme.Clin Transl Immunol. 2021;10(3). doi:10.1002/cti2.1255Takahashi H, Fukunaga A, Hayama K, et al.Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria.Allergology International. September 2024:S1323893024001072. doi:10.1016/j.alit.2024.09.002Giménez‐Arnau A, Maurer M, Bernstein J, et al.Ligelizumab improves sleep interference and disease burden in patients with chronic spontaneous urticaria.Clinical & Translational All. 2022;12(2). doi:10.1002/clt2.12121PharmaTimes.US breakthrough designation for ligelizumab in chronic spontaneous urticaria.U.S. Food and Drug Administration.Frequently asked questions: breakthrough therapies.
15 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Kolkhir P, Altrichter S, Munoz M, Hawro T, Maurer M.New treatments for chronic urticaria.Annals of Allergy, Asthma & Immunology. 2020;124(1):2-12. doi:10.1016/j.anai.2019.08.014Novartis.Novartis provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU).Arm JP, Bottoli I, Skerjanec A, et al.Pharmacokinetics, pharmacodynamics and safety of QGE 031 (Ligelizumab), a novel high‐affinity anti‐IgE antibody, in atopic subjects.Clin Exp Allergy. 2014;44(11):1371-1385 doi:10.1111/cea.12400van den Elzen MT, van Os-Medendorp H, van den Brink I, et al.Effectiveness and safety of antihistamines up to fourfold or higher in treatment of chronic spontaneous urticaria.Clin Transl Allergy. 2017;7(1):4. doi:10.1186/s13601-017-0141-3Arm JP, Bottoli I, Skerjanec A, et al.Pharmacokinetics, pharmacodynamics and safety of QGE 031 (Ligelizumab), a novel high‐affinity anti‐IgE antibody, in atopic subjects.Clin Exp Allergy. 2014;44(11):1371-1385. doi:10.1111/cea.12400Incorvaia C, Mauro M, Russello M, et al.Omalizumab, an anti-immunoglobulin E antibody: state of the art.DDDT. Published online February 2014:197. doi:10.2147/DDDT.S49409Maurer M, Giménez-Arnau AM, Sussman G, et al.Ligelizumab for chronic spontaneous urticaria.N Engl J Med. 2019;381(14):1321-1332. doi:10.1056/NEJMoa1900408Gasser P, Tarchevskaya SS, Guntern P, et al.The mechanistic and functional profile of the therapeutic anti-IgE antibody ligelizumab differs from omalizumab.Nat Commun. 2020;11(1):165. doi:10.1038/s41467-019-13815-wMaurer M, Giménez‐Arnau A, Bernstein JA, et al.Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one‐year extension study.Allergy. 2022;77(7):2175-2184. doi:10.1111/all.15175NIH. ClinicalTrials[dot]gov.A Phase III study of efficacy and safety of ligelizumab in the treatment of CSU in adolescents and adults inadequately controlled with H1-antihistamines.Trischler J, Bottoli I, Janocha R, et al.Ligelizumab treatment for severe asthma: learnings from the clinical development programme.Clin Transl Immunol. 2021;10(3). doi:10.1002/cti2.1255Takahashi H, Fukunaga A, Hayama K, et al.Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria.Allergology International. September 2024:S1323893024001072. doi:10.1016/j.alit.2024.09.002Giménez‐Arnau A, Maurer M, Bernstein J, et al.Ligelizumab improves sleep interference and disease burden in patients with chronic spontaneous urticaria.Clinical & Translational All. 2022;12(2). doi:10.1002/clt2.12121PharmaTimes.US breakthrough designation for ligelizumab in chronic spontaneous urticaria.U.S. Food and Drug Administration.Frequently asked questions: breakthrough therapies.
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
Kolkhir P, Altrichter S, Munoz M, Hawro T, Maurer M.New treatments for chronic urticaria.Annals of Allergy, Asthma & Immunology. 2020;124(1):2-12. doi:10.1016/j.anai.2019.08.014Novartis.Novartis provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU).Arm JP, Bottoli I, Skerjanec A, et al.Pharmacokinetics, pharmacodynamics and safety of QGE 031 (Ligelizumab), a novel high‐affinity anti‐IgE antibody, in atopic subjects.Clin Exp Allergy. 2014;44(11):1371-1385 doi:10.1111/cea.12400van den Elzen MT, van Os-Medendorp H, van den Brink I, et al.Effectiveness and safety of antihistamines up to fourfold or higher in treatment of chronic spontaneous urticaria.Clin Transl Allergy. 2017;7(1):4. doi:10.1186/s13601-017-0141-3Arm JP, Bottoli I, Skerjanec A, et al.Pharmacokinetics, pharmacodynamics and safety of QGE 031 (Ligelizumab), a novel high‐affinity anti‐IgE antibody, in atopic subjects.Clin Exp Allergy. 2014;44(11):1371-1385. doi:10.1111/cea.12400Incorvaia C, Mauro M, Russello M, et al.Omalizumab, an anti-immunoglobulin E antibody: state of the art.DDDT. Published online February 2014:197. doi:10.2147/DDDT.S49409Maurer M, Giménez-Arnau AM, Sussman G, et al.Ligelizumab for chronic spontaneous urticaria.N Engl J Med. 2019;381(14):1321-1332. doi:10.1056/NEJMoa1900408Gasser P, Tarchevskaya SS, Guntern P, et al.The mechanistic and functional profile of the therapeutic anti-IgE antibody ligelizumab differs from omalizumab.Nat Commun. 2020;11(1):165. doi:10.1038/s41467-019-13815-wMaurer M, Giménez‐Arnau A, Bernstein JA, et al.Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one‐year extension study.Allergy. 2022;77(7):2175-2184. doi:10.1111/all.15175NIH. ClinicalTrials[dot]gov.A Phase III study of efficacy and safety of ligelizumab in the treatment of CSU in adolescents and adults inadequately controlled with H1-antihistamines.Trischler J, Bottoli I, Janocha R, et al.Ligelizumab treatment for severe asthma: learnings from the clinical development programme.Clin Transl Immunol. 2021;10(3). doi:10.1002/cti2.1255Takahashi H, Fukunaga A, Hayama K, et al.Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria.Allergology International. September 2024:S1323893024001072. doi:10.1016/j.alit.2024.09.002Giménez‐Arnau A, Maurer M, Bernstein J, et al.Ligelizumab improves sleep interference and disease burden in patients with chronic spontaneous urticaria.Clinical & Translational All. 2022;12(2). doi:10.1002/clt2.12121PharmaTimes.US breakthrough designation for ligelizumab in chronic spontaneous urticaria.U.S. Food and Drug Administration.Frequently asked questions: breakthrough therapies.
Kolkhir P, Altrichter S, Munoz M, Hawro T, Maurer M.New treatments for chronic urticaria.Annals of Allergy, Asthma & Immunology. 2020;124(1):2-12. doi:10.1016/j.anai.2019.08.014
Novartis.Novartis provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU).
Arm JP, Bottoli I, Skerjanec A, et al.Pharmacokinetics, pharmacodynamics and safety of QGE 031 (Ligelizumab), a novel high‐affinity anti‐IgE antibody, in atopic subjects.Clin Exp Allergy. 2014;44(11):1371-1385 doi:10.1111/cea.12400
van den Elzen MT, van Os-Medendorp H, van den Brink I, et al.Effectiveness and safety of antihistamines up to fourfold or higher in treatment of chronic spontaneous urticaria.Clin Transl Allergy. 2017;7(1):4. doi:10.1186/s13601-017-0141-3
Arm JP, Bottoli I, Skerjanec A, et al.Pharmacokinetics, pharmacodynamics and safety of QGE 031 (Ligelizumab), a novel high‐affinity anti‐IgE antibody, in atopic subjects.Clin Exp Allergy. 2014;44(11):1371-1385. doi:10.1111/cea.12400
Incorvaia C, Mauro M, Russello M, et al.Omalizumab, an anti-immunoglobulin E antibody: state of the art.DDDT. Published online February 2014:197. doi:10.2147/DDDT.S49409
Maurer M, Giménez-Arnau AM, Sussman G, et al.Ligelizumab for chronic spontaneous urticaria.N Engl J Med. 2019;381(14):1321-1332. doi:10.1056/NEJMoa1900408
Gasser P, Tarchevskaya SS, Guntern P, et al.The mechanistic and functional profile of the therapeutic anti-IgE antibody ligelizumab differs from omalizumab.Nat Commun. 2020;11(1):165. doi:10.1038/s41467-019-13815-w
Maurer M, Giménez‐Arnau A, Bernstein JA, et al.Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one‐year extension study.Allergy. 2022;77(7):2175-2184. doi:10.1111/all.15175
NIH. ClinicalTrials[dot]gov.A Phase III study of efficacy and safety of ligelizumab in the treatment of CSU in adolescents and adults inadequately controlled with H1-antihistamines.
Trischler J, Bottoli I, Janocha R, et al.Ligelizumab treatment for severe asthma: learnings from the clinical development programme.Clin Transl Immunol. 2021;10(3). doi:10.1002/cti2.1255
Takahashi H, Fukunaga A, Hayama K, et al.Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria.Allergology International. September 2024:S1323893024001072. doi:10.1016/j.alit.2024.09.002
Giménez‐Arnau A, Maurer M, Bernstein J, et al.Ligelizumab improves sleep interference and disease burden in patients with chronic spontaneous urticaria.Clinical & Translational All. 2022;12(2). doi:10.1002/clt2.12121
PharmaTimes.US breakthrough designation for ligelizumab in chronic spontaneous urticaria.
U.S. Food and Drug Administration.Frequently asked questions: breakthrough therapies.
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