Overview
Nemolizumab is under investigation in clinical trial NCT03921411 (A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Subjects With Atopic Dermatitis (AD)).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Nemolizumab: A Comprehensive Profile of a First-in-Class IL-31 Receptor Alpha Antagonist
I. Introduction to Nemolizumab
A. Identification and Classification
Nemolizumab, identified by DrugBank ID DB15252 and Chemical Abstracts Service (CAS) number 1476039-58-3, is a novel biologic therapy developed for chronic inflammatory and pruritic skin conditions.[1] It is classified as a biotech product, specifically a humanized Immunoglobulin G2 (IgG2) monoclonal antibody (mAb).[1] The selection of the IgG2 isotype for nemolizumab is noteworthy; compared to IgG1 antibodies often used in oncology, IgG2 antibodies generally exhibit reduced effector functions, such as antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). This characteristic may represent a deliberate design choice to enhance the safety profile in the context of chronic inflammatory diseases, where the therapeutic goal is primarily modulation of signaling pathways rather than depletion of receptor-bearing cells.[1]
Nemolizumab functions as a highly specific Interleukin-31 Receptor alpha (IL-31RA) antagonist.[1] It is marketed under the brand name Nemluvio® in the United States (US), European Union (EU), United Kingdom (UK), and Switzerland, and as Mitchga® in Japan.[1] Other identifiers used during its development include CIM-331 and the nonproprietary name suffix nemolizumab-ilto.[2]
As a monoclonal antibody, nemolizumab is a large protein molecule with an approximate average molecular weight of 144 kDa.[1] Detailed amino acid sequence information for its constituent heavy and light chains is publicly available.[3]
B. Development and Commercialization History
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/02 | Not Applicable | Not yet recruiting | |||
2022/06/06 | Phase 1 | Completed | |||
2022/01/31 | Phase 2 | Completed | |||
2021/10/12 | Phase 2 | Completed | |||
2021/09/27 | Phase 3 | Withdrawn | |||
2021/09/22 | Phase 3 | Completed | |||
2021/06/10 | Phase 2 | Recruiting | |||
2020/09/24 | Phase 2 | Completed | |||
2020/08/06 | Phase 3 | Completed | |||
2020/08/06 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/12/2025 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NEMLUVIO POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 30MG | SIN17207P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 30mg | 3/17/2025 | |
| NEMLUVIO POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED PEN 30MG | SIN17206P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 30mg | 3/17/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| NEMLUVIO nemolizumab 30mg powder and solution for injection pre filled pen | 444530 | Medicine | A | 5/27/2025 | |
| NEMLUVIO nemolizumab 30mg powder and solution for injection pre filled syringe | 444531 | Medicine | A | 5/27/2025 |
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