Nipocalimab

Nipocalimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetFcRn
Clinical data
Trade namesImaavy
Other namesnipocalimab-aahu
AHFS/Drugs.comMultum Consumer Information
License data
Routes of
administration
Intravenous infusion
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6266H9722N1670O1992S46
Molar mass141797.16 g·mol−1

Nipocalimab, sold under the brand name Imaavy, is a monoclonal antibody used for the treatment of generalized myasthenia gravis.[1] It is a neonatal Fc receptor blocker.[1] It is an high affinity, fully human, aglycosylated, effectorless immunoglobulin G (IgG) anti-FcRn monoclonal antibody.[2][3]

Nipocalimab was approved for medical use in the United States in April 2025.[4][5]

  1. ^ a b c "Imaavy- nipocalimab injection, solution, concentrate". DailyMed. 6 May 2025. Retrieved 24 June 2025.
  2. ^ Cite error: The named reference :0 was invoked but never defined (see the help page).
  3. ^ Seth NP, Xu R, DuPrie M, Choudhury A, Sihapong S, Tyler S, et al. (December 2025). "Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties". mAbs. 17 (1): 2461191. doi:10.1080/19420862.2025.2461191. PMC 11834464. PMID 39936406.
  4. ^ "Novel Drug Approvals for 2025". U.S. Food and Drug Administration (FDA). 1 May 2025. Archived from the original on 3 March 2025. Retrieved 1 May 2025.
  5. ^ "Johnson & Johnson receives FDA approval for Imaavy (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG)" (Press release). Johnson & Johnson. 30 April 2025. Archived from the original on 1 May 2025. Retrieved 1 May 2025 – via MultiVu.