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Synonyms: Imaavy® | M-281 | M281 | nipocalimab-aahu
nipocalimab is an approved drug
Compound class:
Antibody
Comment: Nipocalimab (M281) is a fully human neonatal Fc receptor (FcRn; Fc gamma receptor and transporter FCGRT) targeting monoclonal antibody [2], that is designed to reduce circulating IgG antibody levels, with the focus on neutralising pathogenic autoantibodies in autoimmune diseases [3]. Its binding is pH insensitive, so it can bind IgG throughout the FcRn-mediated IgG recycling pathway, in the endosomal and extracellular compartments.
Ligand Activity Visualisation ChartsThese are box plot that provide a unique visualisation, summarising all the activity data for a ligand taken from ChEMBL and GtoPdb across multiple targets and species. Click on a plot to see the median, interquartile range, low and high data points. A value of zero indicates that no data are available. A separate chart is created for each target, and where possible the algorithm tries to merge ChEMBL and GtoPdb targets by matching them on name and UniProt accession, for each available species. However, please note that inconsistency in naming of targets may lead to data for the same target being reported across multiple charts. ✖ |
| No information available. |
Summary of Clinical Use  |
| Mipocalimab (M281) was advanced to clinical trials to determine safety and efficacy in the treatment of various autoimmune conditions. It was first approved (as Imaavy®) by the FDA in Aptil 2025, to treat generalized myasthenia gravis [1]. |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT04951622 | A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis | Phase 3 Interventional | Janssen Research & Development, LLC | ||
| NCT04991753 | A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis | Phase 2 Interventional | Janssen Research & Development, LLC | ||
| NCT05265273 | A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis | Phase 2/Phase 3 Interventional | Janssen Research & Development, LLC | ||
| NCT05912517 | A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) | Phase 3 Interventional | Janssen Research & Development, LLC | ||
| NCT06028438 | A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis | Phase 2 Interventional | Janssen Research & Development, LLC | ||
| NCT06741969 | Nipocalimab in Moderate to Severe Sjogren's Disease | Phase 3 Interventional | Janssen Research & Development, LLC | ||
