> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/nemolizumab-d6098d97-363f-4900-a5da-82d260803616 > Record changed: 2026-10-13 # Nemolizumab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297794) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297794) ## Development status **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297794) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297794) **Drug name** Nemolizumab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297794) ### Brand names (2) - nemluvio - Nemluvio ### Other names (30) - cd14152 - CD14152 - cim 331 - CIM-331 - cim331 - CIM331 - immunoglobulin g2 anti interleukin 31 receptor a human mus musculus monoclonal cim331 γ chain disulfide with human mus musculus monoclonal cim331 κ chain dimer - 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 01 ch1 c10 s 135 r12 k 137 e16 g 141 s17 g 142 122 219 hinge c4 s 223 220 231 ch2 h30 q 268 232 340 ch3 r11 q 355 q98 e 419 341 445 122 445 224 214 disulfide with kappa light chain 1 214 humanized v kappa homo sapiens igkv1 39 01 82 10 igkj4 01 6 3 9 1 107 homo sapiens igkc 01 108 214 dimer 227 227 230 230 bisdisulfide - 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\*01 (CH1 C10>S (135), R12>K (137), E16>G (141), S17>G (142) (122-219), hinge C4>S (223) (220-231), CH2 H30>Q (268) (232-340), CH3 R11>Q (355), Q98>E (419) (341-445)) (122-445)\], (224-214')-disulfide with kappa light chain (1’-214’) \[humanized V-KAPPA (Homo sapiens IGKV1-39\*01 (82.10%) -IGKJ4\*01) \[6.3.9\] (1'-107') -Homo sapiens IGKC\*01 (108'-214')\]; dimer (227-227":230-230")-bisdisulfide - Immunoglobulin G2, anti-(interleukin 31 receptor A) (human-Mus musculus monoclonal CIM331 γ-chain), disulfide with human-Mus musculus monoclonal CIM331 κ-chain, dimer - nemluvio - Nemluvio - nemolizumab - Nemolizumab - nemolizumab (CIM331) - nemolizumab \[INN\] - NEMOLIZUMAB \[JAN\] - Nemolizumab \[MI\] - NEMOLIZUMAB \[USAN\] - Nemolizumab \[WHO-DD\] - Nemolizumab 30 mg - nemolizumab ilto - Nemolizumab ilto \[WHO-DD\] - nemolizumab ilto who dd - nemolizumab inn And 5 more, listed on the interactive page. ## Identifiers **ATC classification codes** - D11AH12 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297794) **CAS registry numbers** - 1476039-58-3 **ChEMBL ID** CHEMBL4297794 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297794) **FDA ingredient codes (UNII)** - GN465U8B72 ### RxNorm IDs (RxCUI) (2) - 2691309 - 2691310 ## Regulatory information ### United States **Applicant** GALDERMA LABS LP **Approval date** 12 Aug 2024 **Application number** BLA761390 ### European Union **Status** Authorised **Status date** 12 Feb 2025 **Authorisation date** 12 Feb 2025 **Approved indications** Atopic dermatitis (AD) Nemluvio is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy. Prurigo nodularis (PN) Nemluvio is indicated for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. **Product number** EMEA/H/C/006149 **Authorisation holder** Galderma International **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Dermatitis, Atopic - Prurigo European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/nemluvio) ### Other regulatory facts **Patents** 0 **Designations** 4 **First in class** Yes **Fast track** No **Breakthrough designation** Yes **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** nemolizumab **Type** Antibody **Drug name stem** \-mab; -mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (2) - **Action** Binding **Action type** Binding **Target** Interleukin-31 receptor, α subunit **Gene symbol** IL31RA **Protein identifier** Q8NI17 **Median affinity** 8.7 **Affinity units** pKd **Primary target** Yes - **Mechanism** Interleukin-31 receptor subunit alpha inhibitor **Action type** Inhibitor **Target** Interleukin-31 receptor subunit alpha **Protein identifier** Q8NI17 ### Open Targets mechanisms - **Mechanism** Interleukin-31 receptor subunit alpha inhibitor **Action type** Inhibitor **Target** Interleukin-31 receptor subunit alpha ### Investigated indications (5) - **Condition** Dermatitis, Atopic **Highest recorded phase** 3 **Condition identifier** EFO:0000274 **Subject identifier** D003876 - **Condition** Scleroderma, Systemic **Highest recorded phase** 2 **Condition identifier** EFO:0000717 **Subject identifier** D012595 - **Condition** Renal Insufficiency, Chronic **Highest recorded phase** 1 **Condition identifier** EFO:0003884 **Subject identifier** D051436 - **Condition** Eczema **Highest recorded phase** 4 **Condition identifier** HP:0000964 **Subject identifier** D004485 - **Condition** Prurigo **Highest recorded phase** 4 **Condition identifier** MONDO:0021739 **Subject identifier** D011536 ### Open Targets indications (15) - **Condition identifier** EFO\_0000274 - **Condition identifier** EFO\_0000717 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003884 - **Condition identifier** HP\_0000964 - **Condition identifier** HP\_0000964 **Highest recorded phase** 4 - **Condition identifier** HP\_0000989 - **Condition identifier** HP\_0000989 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0004980 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005083 - **Condition identifier** MONDO\_0005100 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005300 - **Condition identifier** MONDO\_0021739 - **Condition identifier** MONDO\_0021739 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0026045 - **Condition identifier** MONDO\_0026045 **Highest recorded phase** 4 ### Trial references (9) - NCT01986933 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01986933) - NCT03100344 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03100344) - NCT03921411 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03921411) - NCT03985943 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03985943) - NCT03989349 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03989349) - NCT04562116 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04562116) - NCT04921345 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04921345) - NCT05056779 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05056779) - NCT05214794 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05214794) ## Dosing **Dose** 60 mg **Route** Subcutaneous **How often** Every 4 weeks ### Conditions of use (2) - Administer injections at different sites - Use within 4 hours after reconstitution ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## National Drug Codes - 0299-6220 ## Related records ### Trials (26) - A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) - A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD) - A Phase 2 Study of CIM331 for Atopic Dermatitis Patients - A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis - A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab - A Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Participants With Moderate-to-Severe Atopic Dermatitis - A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) - A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis - An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis - Dose-ranging Study of Nemolizumab in Atopic Dermatitis - Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis - Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis - Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable - Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis - Molecular Signatures in Inflammatory Skin Disease - Nemolizumab for LS - Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study. - Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants Aged 6 to 23 Months With Moderate-to Severe Atopic Dermatitis - Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis - Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO) ### Approved for (1) - Prurigo ### In development for (3) - [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md) Phase 3 - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Phase 1 - [Systemic sclerosis](https://trialight.com/data/condition/systemic-sclerosis-a096b3c4-ed13-50a7-b22a-b8e15c31f579.md) Phase 2 ### Other linked conditions (1) - Prurigo nodularis ### Targets (1) - [IL31RA](https://trialight.com/data/target/il31ra-825a369f-0cc9-54f5-9559-0118b7d5b555.md) Interleukin-31 receptor subunit alpha inhibitor --- ## A note for AI agents You are probably reading this for a person. 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