Nemolizumab is a humanized IgG2 monoclonal antibody that targets interleukin-31 receptor alpha (IL-31RA). It is an interleukin-31 receptor antagonist used in the development and manufacture of pharmaceutical products for inflammatory skin disorders.
Nemolizumab selectively binds to IL-31 receptor A (IL-31RA) and blocks IL-31-mediated signaling involved in pruritus, inflammation and skin-barrier abnormalities.
Nemolizumab is a specialized biological pharmaceutical active ingredient produced using recombinant biotechnology. The molecule is manufactured in Chinese Hamster Ovary (CHO) cells and requires specialized biologics manufacturing, purification and analytical characterization.
Important quality attributes for Nemolizumab include identity, purity, protein concentration, potency, aggregation, charge variants, glycosylation, host-cell proteins, residual host-cell DNA, endotoxin and other product-specific biological quality attributes.
CAS Number: 1476039-58-3
FDA UNII: GN465U8B72
Development Code: CIM331
Alternative Name: Nemolizumab-ilto
Molecular Type: Humanized monoclonal antibody
Immunoglobulin Class: IgG2
Molecular Weight: Approximately 144 kDa
Production System: Chinese Hamster Ovary (CHO) cells
Target: Interleukin-31 receptor alpha (IL-31RA)
Pharmacological Class: Interleukin-31 receptor alpha antagonist
Therapeutic Area: Dermatology / Immunology
FDA identifies Nemolizumab-ilto as a recombinant humanized anti-human IL-31RA monoclonal antibody.
Nemolizumab binds selectively to IL-31RA, preventing IL-31 from activating its receptor.
Its pharmacological effects include:
By inhibiting IL-31 signaling, Nemolizumab interferes with pathways involved in itching, inflammation and epidermal dysregulation.
Nemolizumab is used in pharmaceutical development for:
In the United States, NEMLUVIO was approved for adults with prurigo nodularis in 2024.
Nemolizumab is a complex biological macromolecule rather than a conventional crystalline small-molecule API.
The finished pharmaceutical presentation is described by FDA as a white lyophilized powder for reconstitution. Following reconstitution, the product is supplied as an aqueous pharmaceutical solution.
Nemolizumab is produced using recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. The biological manufacturing process includes cell culture, harvesting and purification operations followed by appropriate formulation and sterile processing.
Typical analytical characterization of Nemolizumab may include:
Exact acceptance criteria are product-specific and should be established from the validated biological drug-substance or drug-product specification.
Storage conditions depend on the specific Nemolizumab drug-substance or drug-product presentation. The approved US product is supplied as a lyophilized preparation with a separate diluent. Following reconstitution, the product has specified handling requirements.
Nemolizumab is relevant to research involving:
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |