Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 158 |
| INN | Rozanolixizumab |
| Status | Approved |
| Drug code(s) | UCB7665 |
| Brand name | RYSTIGGO® |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | FcRn |
| Indications of clinical studies | Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis, Generalized Myasthenia Gravis, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Primary immune thrombocytopenia, Myasthenia gravis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 15, 2014 |
| Start of Phase 2 | December 15, 2015 |
| Start of Phase 3 | June 03, 2019 |
| Date BLA/NDA submitted to FDA | October 24, 2022 |
| Year of first approval (global) | 2023 |
| Date of first US approval | June 26, 2023 |
| INN, US product name | Rozanolixizumab, rozanolixizumab-noli |
| US or EU approved indications | Treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive |
| Company | UCB |
| Licensee/Partner | None |
| Comments about company or candidate | 08 January 2024 – UCB announced that the European Commission (EC) has granted a marketing authorization for RYSTIGGO® (rozanolixizumab) on 5th January 2024 as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive1. UCB announced US approval on June 27, 2023. Pivotal study results discussed at 75th American Academy of Neurology (AAN) Annual Meeting, April 22-27, 2023 Jan 6, 2023: U.S. Food and Drug Administration has accepted the company’s filing to review a Biologic License Application for its investigational treatment rozanolixizumab, and that the Agency has granted Priority Review.1 Rozanolixizumab is a subcutaneous (SC) monoclonal antibody targeting the neonatal Fc receptor (FcRn) for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetycholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. Est PDUFA date in July 2023. EMA evaluation started Dec 1, 2022. Aug 2022: Phase 3 in Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease recruiting; NCT04200456 Phase 3 in ITP terminated (Strategic Business Decision; Not a safety decision) H1 2022 report: UCB decided to de-prioritize the development of rozanolixizumab in immune thrombocytopenia (ITP). Since UCB took the decision to progress the rozanolixizumab ITP development program to Phase 3 in 2019, the treatment landscape for people living with ITP has significantly evolved. New targeted therapies, offering multiple opportunities to transform the care and management of ITP, are now available or in late-stage development. This evolution looks set to address many of the significant unmet needs faced by the ITP patient community. Taking these factors into account, UCB will not progress with the rozanolixizumab ITP development program. This allows UCB to reallocate resources to areas with higher unmet medical needs. All other rozanolixizumab programs will continue as previously communicated and announced. NCT04650854 Phase 3 in MG started in Feb 2021 active not recruiting as of last update in July 2022; positive results reported. NCT04224688 Phase 3 started recruiting in June 2020. NCT04200456 Phase 3 in Primary Immune Thrombocytopenia not yet recruiting as of Dec 16 2019. NCT04124965 Phase 3 in Myasthenia Gravis not yet recruiting as of Oct 15 2019. NCT04051944 Phase 2 study in Chronic Inflammatory Demyelinating Polyradiculoneuropathy not yet recruiting as of Aug 9 2019. NCT03971422 Phase 3 study in Myasthenia Gravis started recruiting Jun 3, 2019. NCT03861481 Phase 2 study recruiting as of March 26, 2019. NCT03859219 Phase 1 in healthy volunteers not yet recruiting as of March 21, 2019. October 18, 2018: UCB today announced positive results from a phase 2 study (MG0002; NCT03052751) with a novel, subcutaneous FcRn (neonatal Fc receptor) monoclonal antibody, rozanolixizumab, in patients with myasthenia gravis (MG), achieving proof-of-concept. Based on these results UCB intends to accelerate the development of rozanolixizumab with a confirmatory study in MG starting in the second half of 2019. Phase 2a results in ITP and MG expected in 2018. Phase 2 EU clinical trial 2015-003984-12 |
| Full address of company | Allée de la Recherche, 60 1070 Brussels Belgium Europe Belgium https://www.ucb.com/contact |
Humanized rat antibody
| Anticipated events | Regulatory review China, Australia, Canada, Switzerland |
| Factor(s) contributing to discontinuation | None |