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Identification
- Summary
Nemolizumab is an interleukin-31 receptor alpha antagonist used to treat prurigo nodularis in adults.
- Brand Names
- Nemluvio
- Generic Name
- Nemolizumab
- DrugBank Accession Number
- DB15252
- Background
Nemolizumab is a humanized monoclonal modified immunoglobulin 2 (IgG2) antibody directed against interleukin-31 receptor alpha (IL-31RA),8 which is an endogenous cytokine implicated in the pathophysiology of various skin inflammatory disorders.1 By binding to IL-31RA, nemolizumab blocks the IL-31 signalling cascades that lead to inflammation.8 Nemolizumab gained its first global approval in Japan on March 28, 2022, for the treatment of atopic dermatitis.5 It was later approved by the FDA on August 13, 2024, for the treatment of prurigo nodularis.9
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Monoclonal antibody (mAb) - Protein Chemical Formula
- C6384H9814N1678O2034S48
- Protein Average Weight
- 144000.0 Da (approximate)
- Sequences
>Nemolizumab heavy chain QVQLVQSGAEVKKPGASVKVSCKASGYTFTGYIMNWVRQAPGQGLEWMGLINPYNGGTDY NPQFQDRVTITADKSTSTAYMELSSLRSEDTAVYYCARDGYDDGPYTLETWGQGTLVTVS SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS SGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKSCVECPPCPAPPVAGPSV FLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTF RVVSVLTVVHQDWLNGKEYKCKVSNKGLPAPIEKTISKTKGQPREPQVYTLPPSQEEMTK NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQEG NVFSCSVMHEALHNHYTQKSLSLSP
>Nemolizumab light chain DIQMTQSPSSLSASVGDRVTITCQASEDIYSFVAWYQQKPGKAPKLLIYNAQTEAQGVPS RFSGSGSGTDFTLTISSLQPEDFATYYCQHHYDSPLTFGGGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Download FASTA FormatReferences:
- KEGG DRUG: Nemolizumab [Link]
- Synonyms
- immunoglobulin G2-kappa, anti-[Homo sapiens IL31RA (interleukin 31 receptor subunit alpha)], humanized monoclonal antibody gamma2 heavy chain (1-445) [humanized VH (Homo sapiens IGHV1-2*02 (83.70%) -(IGHD)-IGHJ5*01) [8.8.14] (1-121) -Homo sapiens IGHG2*0
- Immunoglobulin G2, anti-(interleukin 31 receptor A) (human-Mus musculus monoclonal CIM331 γ-chain), disulfide with human-Mus musculus monoclonal CIM331 κ-chain, dimer
- Nemolizumab
- External IDs
- CIM 331
- CIM-331
- CIM331
Pharmacology
- Indication
Nemolizumab is indicated for the treatment of adults with prurigo nodularis.8
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Treatment of Prurigo nodularis •••••••••••• ••••• - Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
Nemolizumab is a neuroimmune response modulator.3 In a phase III clinical trial with adults who have moderate-to-severe prurigo nodularis, treatment with nemolizumab resulted in an improvement in the signs and symptoms of prurigo nodularis, including an itch response and itch-related sleep disturbances.3,4
- Mechanism of action
Interleukin-31 (IL-31) is a cytokine involved in neuroimmune communication. It is identified as one of the key drivers in inflammatory and immune conditions, such as pruritus, inflammation, epidermal dysregulation, and fibrosis.1,2,8 The release of IL-31 is stimulated by T helper 2 (TH2) cells to mediate pro-inflammatory responses.1 IL-31 signals through a heterodimeric receptor complex consisting of IL-31 receptor alpha (α)-chain (IL-31RA) and oncostatin M receptor beta (β).6,7 Nemolizumab is a humanized IgG2 monoclonal antibody that inhibits IL-31 signalling by binding selectively to IL-31RA. Nemolizumab inhibits IL-31-induced responses, including the release of proinflammatory cytokines and chemokines.8
Target Actions Organism AInterleukin-31 receptor subunit alpha antagonistantibodyHumans - Absorption
After a single dose, nemolizumab exposure increased dose proportionally over a dose range of 0.03 and 3 mg/kg following subcutaneous administration. After multiple doses, drug systemic exposure increased in an approximately dose-proportional manner across the subcutaneous dose range up to 30 mg. There was a decrease in bioavailability by 9% with the 60 mg subcutaneous dose and by 15% with the 90 mg subcutaneous dose.8
Following multiple doses of nemolizumab in subjects with prurigo nodularis, the estimated mean (SD) steadystate trough concentrations of nemolizumab were 3.04 (1.23) µg/mL in subjects with bodyweight less than 90 kg; and 3.66 (1.63) µg/mL in subjects with bodyweight of 90 kg or more. Steady state nemolizumab concentrations were achieved by week four in subjects weighting less than 90 kg and by week 12 in subjects weighing 90 kg or more. Following an initial subcutaneous dose of 60 mg, nemolizumab reached peak mean (SD) concentrations (Cmax) of 7.5 (2.31) µg/mL by approximately six days post-dose.8
- Volume of distribution
The estimated volume of distribution is 7.67 L.8
- Protein binding
Not Available
- Metabolism
The metabolic pathway of nemolizumab has not been characterized. In the same manner as endogenous IgG, nemolizumab is expected to be degraded into small peptides by catabolic pathways.8
- Route of elimination
Not Available
- Half-life
The estimated terminal elimination half-life (SD) of nemolizumab is 18.9 (4.96) days.8
- Clearance
The estimated systemic clearance is 0.263 L/day.8
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
There is no information regarding the acute toxicity (LD50) and overdose of nemolizumab.8
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Nemolizumab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Nemolizumab. Aducanumab The risk or severity of adverse effects can be increased when Aducanumab is combined with Nemolizumab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Nemolizumab. Alirocumab The risk or severity of adverse effects can be increased when Alirocumab is combined with Nemolizumab. - Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Nemluvio Injection, powder, lyophilized, for solution 30 mg/100mg Subcutaneous Galderma Laboratories, L.P. 2024-08-13 Not applicable US 
Categories
- ATC Codes
- D11AH12 — Nemolizumab
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- GN465U8B72
- CAS number
- 1476039-58-3
References
- General References
- Datsi A, Steinhoff M, Ahmad F, Alam M, Buddenkotte J: Interleukin-31: The "itchy" cytokine in inflammation and therapy. Allergy. 2021 Oct;76(10):2982-2997. doi: 10.1111/all.14791. Epub 2021 Mar 16. [Article]
- Labib A, Vander Does A, Yosipovitch G: Nemolizumab for atopic dermatitis. Drugs Today (Barc). 2022 Apr;58(4):159-173. doi: 10.1358/dot.2022.58.4.3378056. [Article]
- Stander S, Yosipovitch G, Lacour JP, Legat FJ, Paul C, Reich A, Chaouche K, Ahmad F, Piketty C: Nemolizumab efficacy in prurigo nodularis: onset of action on itch and sleep disturbances. J Eur Acad Dermatol Venereol. 2022 Oct;36(10):1820-1825. doi: 10.1111/jdv.18377. Epub 2022 Jul 4. [Article]
- Kwatra SG, Yosipovitch G, Legat FJ, Reich A, Paul C, Simon D, Naldi L, Lynde C, De Bruin-Weller MS, Nahm WK, Sauder M, Gharib R, Barbarot S, Szepietowski JC, Conrad C, Fleischer A, Laquer VT, Misery L, Serra-Baldrich E, Lapeere H, Ahmad F, Jabbar Lopez ZK, Piketty C, Stander S: Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. N Engl J Med. 2023 Oct 26;389(17):1579-1589. doi: 10.1056/NEJMoa2301333. [Article]
- Keam SJ: Nemolizumab: First Approval. Drugs. 2022 Jul;82(10):1143-1150. doi: 10.1007/s40265-022-01741-z. Epub 2022 Jul 14. [Article]
- Sonkoly E, Muller A, Lauerma AI, Pivarcsi A, Soto H, Kemeny L, Alenius H, Dieu-Nosjean MC, Meller S, Rieker J, Steinhoff M, Hoffmann TK, Ruzicka T, Zlotnik A, Homey B: IL-31: a new link between T cells and pruritus in atopic skin inflammation. J Allergy Clin Immunol. 2006 Feb;117(2):411-7. doi: 10.1016/j.jaci.2005.10.033. [Article]
- Bagci IS, Ruzicka T: IL-31: A new key player in dermatology and beyond. J Allergy Clin Immunol. 2018 Mar;141(3):858-866. doi: 10.1016/j.jaci.2017.10.045. Epub 2018 Feb 1. [Article]
- FDA Approved Drug Products: NEMLUVIO (nemolizumab-ilto) for injection, for subcutaneous use [Link]
- Fierce Pharma: Itching for leadership in 'therapeutic dermatology,' Galderma wins FDA nod for Nemluvio to treat prurigo nodularis [Link]
- External Links
- 2691310
- Wikipedia
- Nemolizumab
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample data3 Active Not Recruiting Treatment Moderate to Severe Atopic Dermatitis 1 somestatus stop reason just information to hide 3 Active Not Recruiting Treatment Prurigo Nodularis 1 somestatus stop reason just information to hide 3 Completed Treatment Moderate to Severe Atopic Dermatitis 2 somestatus stop reason just information to hide 3 Completed Treatment Prurigo Nodularis 3 somestatus stop reason just information to hide 3 Withdrawn Treatment Moderate to Severe Atopic Dermatitis 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, lyophilized, for solution Subcutaneous 30 mg/100mg - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- AntagonistAntibody
- General Function
- Associates with OSMR to form the interleukin-31 receptor which activates STAT3 and to a lower extent STAT1 and STAT5 (PubMed:11877449, PubMed:14504285, PubMed:15194700, PubMed:15627637). May function in skin immunity (PubMed:15184896). Mediates IL31-induced itch, probably in a manner dependent on cation channels TRPA1 and TRPV1 (By similarity). Positively regulates numbers and cycling status of immature subsets of myeloid progenitor cells in bone marrow in vivo and enhances myeloid progenitor cell survival in vitro (By similarity)
- Specific Function
- cytokine binding
- Gene Name
- IL31RA
- Uniprot ID
- Q8NI17
- Uniprot Name
- Interleukin-31 receptor subunit alpha
- Molecular Weight
- 82953.195 Da
References
Drug created at May 20, 2019 15:04 / Updated at August 28, 2024 20:13