Evidence map›Paper›PMID 39936406›Full record

ArticlemAbs2025

Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties.

Nilufer P Seth, Rui Xu, Matthew DuPrie, Amit Choudhury, Samuel Sihapong, Steven Tyler, James Meador, William Avery, Edward Cochran, Thomas Daly and 19 more

Abstract read
In one paragraph

Article in mAbs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed.

  1. Trial
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  4. Observational
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  7. Article
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  9. Review
  10. Article
  11. Targeting FcRn for immunomodulation: a promising therapy in autoimmune inflammatory rheumatic diseases.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2026
    Review
  12. Review
  13. Review
  14. Article
  15. Article
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  17. Review
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  19. Review
  20. Nipocalimab Dose Selection in Generalized Myasthenia Gravis.CPT: pharmacometrics & systems pharmacology · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Nilufer P SethJohnson & Johnson, USA.
Rui XuJohnson & Johnson, USA.
Matthew DuPrieJohnson & Johnson, USA.
Amit ChoudhuryJohnson & Johnson, USA.
Samuel SihapongJohnson & Johnson, USA.
Steven TylerJohnson & Johnson, USA.
James MeadorJohnson & Johnson, USA.
William AveryJohnson & Johnson, USA.
Edward CochranJohnson & Johnson, USA.
Thomas DalyJohnson & Johnson, USA.
Julia BrownJohnson & Johnson, USA.
Laura RutitzkyJohnson & Johnson, USA.
Lynn MarkowitzJohnson & Johnson, USA.
Sujatha KumarJohnson & Johnson, USA.
Traymon BeaversJohnson & Johnson, USA.
Sayak BhattacharyaJohnson & Johnson, USA.
Hsin ChenJohnson & Johnson, USA.
Viraj PargeJohnson & Johnson, USA.
Karen PriceJohnson & Johnson, USA.
Yang WangJohnson & Johnson, USA.
Siddharth SukumaranJohnson & Johnson, USA.
Yvonne PaoJohnson & Johnson, USA.
Katie AbouzahrJohnson & Johnson, USA.
Fiona ElwoodJohnson & Johnson, USA.
Jay DuffnerJohnson & Johnson, USA.
Sucharita RoyJohnson & Johnson, USA.
Pushpa NarayanaswamiDepartment of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Jonathan J HubbardJohnson & Johnson, USA.
Leona E LingJohnson & Johnson, USA.ORCID 0000-0001-7251-9985

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nipocalimab is a human immunoglobulin G (IgG)1 monoclonal antibody that binds to the neonatal Fc receptor (FcRn) with high specificity and high affinity at both neutral (extracellular) and acidic (intracellular) pH, resulting in the reduction of circulating IgG levels, including those of pathogenic IgG antibodies. Here, we present the molecular, cellular, and nonclinical characteristics of nipocalimab that support the reported clinical pharmacology and potential clinical application in IgG-driven, autoantibody- and alloantibody-mediated diseases. The crystal structure of the nipocalimab antigen binding fragment (Fab)/FcRn complex reveals its binding to a unique epitope on the IgG binding site of FcRn that supports the observed pH-independent high-binding affinity to FcRn. Cell-based and in vivo studies demonstrate concentration/dose- and time-dependent FcRn occupancy and IgG reduction. Nipocalimab selectively reduces circulating IgG levels without detectable effects on other adaptive and innate immune functions. In vitro experiments and in vivo studies in mice and cynomolgus monkeys generated data that align with observations from clinical studies of nipocalimab in IgG autoantibody- and alloantibody-mediated diseases.

Indexed as

Antibodies, Monoclonal, HumanizedHistocompatibility Antigens Class IImmunoglobulin GReceptors, FcAnimalsHumansMacaca fascicularisMiceAntibodies, Monoclonal, HumanizedFc receptor, neonatalHistocompatibility Antigens Class IImmunoglobulin GReceptors, FcAdaptive immune functionsFcRn blockersinnate immune functionsin vivo modelsmolecular propertiespharmacologic properties

Identifiers

PMID39936406
PMCPMC11834464

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.