rozanolixizumab   Click here for help

GtoPdb Ligand ID: 9801

Synonyms: CA170_01519.g57 IgG4P | rozanolixizumab-noli | Rystiggo® | UCB-7665 | UCB7665
Approved drug Immunopharmacology Ligand
rozanolixizumab is an approved drug (FDA (2023))
Compound class: Antibody
Comment: Rozanolixizumab is an anti-human FcRn monoclonal antibody that is being developed for potential use in the treatment of IgG-driven autoimmune diseases [1,3-4].
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No information available.
Summary of Clinical Use Click here for help
Rozanolixizumab (as research code UCB7665) was progressed into clinical trial in patients with myasthenia gravis and primary immune thrombocytopenia. EMA orphan designation as a treatment for myasthenia gravis has been in place since 2019.
First FDA approval was granted in June 2023, with rozanolixizumab authorised to treat patients with generalized myasthenia gravis who are positive for anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibodies [2].
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT02718716 Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia Phase 2 Interventional UCB Pharma
NCT03052751 Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis. Phase 2 Interventional UCB Pharma