Nemolizumab

Nemolizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetInterleukin-31 receptor A
Clinical data
Trade namesNemluvio
Other namesCIM-331, CD14152, nemolizumab-ilto
AHFS/Drugs.comMonograph
MedlinePlusa624059
License data
Routes of
administration
Subcutaneous injection
ATC code
Legal status
Legal status
Pharmacokinetic data
MetabolismProteolytic enzymes
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG

Nemolizumab, sold under the brand name Nemluvio, is a humanized monoclonal antibody used for the treatment of prurigo nodularis and atopic dermatitis.[1] It is a monoclonal antibody that blocks the interleukin-31 receptor A.[1][4] Nemolizumab is humanized IgG2 monoclonal antibody that inhibits interleukin-31 signaling by binding selectively to interleukin-31 receptor alpha.[2] It is an interleukin-31 receptor antagonist.[1] IL-31 is a cytokine involved in pruritus, inflammation, epidermal dysregulation and fibrosis.[2] By inhibiting IL-31-induced responses, nemolizumab prevents the release of proinflammatory cytokines and chemokines.[2]

Nemolizumab was approved for medical use in the United States in August 2024,[4][5][6] and in the European Union in February 2025.[2][3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]

  1. ^ a b c d "Nemluvio- nemolizumab-ilto injection, powder, lyophilized, for solution". DailyMed. 13 August 2024. Retrieved 5 September 2024.
  2. ^ a b c d e Cite error: The named reference Nemluvio EPAR was invoked but never defined (see the help page).
  3. ^ a b Cite error: The named reference Nemluvio PI was invoked but never defined (see the help page).
  4. ^ a b "Drug Trials Snapshots: Nemluvio". U.S. Food and Drug Administration (FDA). 1 October 2024. Archived from the original on 9 November 2024. Retrieved 31 October 2024. This article incorporates text from this source, which is in the public domain.
  5. ^ "Drug Approval Package: Nemluvio". U.S. Food and Drug Administration (FDA). 10 September 2024. Archived from the original on 28 September 2024. Retrieved 13 December 2024.
  6. ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.
  7. ^ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.