Nemolizumab
Highest phase reached
Approved
Drug type
Antibody
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Nemolizumab
- nemluvio
- Nemluvio
- 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.
- ATC classification codes
- D11AH12
Sources for recorded values
- CAS registry numbers
- 1476039-58-3
- ChEMBL ID
- CHEMBL4297794
- FDA ingredient codes (UNII)
- GN465U8B72
- 2691309
- 2691310
- Applicant
- GALDERMA LABS LP
- Approval date
- 12 Aug 2024
- Application number
- BLA761390
- 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
- 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 name
- nemolizumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- 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
- 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
- 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
- NCT01986933
- NCT03100344
- NCT03921411
- NCT03985943
- NCT03989349
- NCT04562116
- NCT04921345
- NCT05056779
- NCT05214794
- Dose
- 60 mg
- Route
- Subcutaneous
- How often
- Every 4 weeks
- Administer injections at different sites
- Use within 4 hours after reconstitution
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 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 Phase 3
- Chronic kidney disease Phase 1
- Systemic sclerosis Phase 2
Other linked conditions (1)
- Prurigo nodularis
Targets (1)
- IL31RA Interleukin-31 receptor subunit alpha inhibitor