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Drug

Nemolizumab

Approved · EMA
ClassInterleukin-31 receptor subunit alpha inhibitorEmerging researchLate-stage development

Also known as Nemluvio.

RxNorm2691310ChEMBLCHEMBL4297794ATCD11AH12UNIIGN465U8B72
2
Research papers
7
Active clinical trials
IL31RA
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (Aged 2 to 11 Years) With Moderate-to-Severe Atopic Dermatitis

Clinical trial2026-06-25Results posted · ClinicalTrials.gov

A Multicenter, Open-Label, Single-Group Clinical Study to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab in Pediatric Subjects (Aged 6 to 23 Months) With Moderate-to-Severe Atopic Dermatitis Not Adequately Controlled With Topical Therapy

Clinical trial2026-06-22Results expected Q3 2028 · ClinicalTrials.gov

Utilization of a Cutaneous Therapy In Situ Microdevice

Clinical trial2026-06-03Results expected Q2 2030 · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Assess Immunization Responses in Adult and Adolescent Subjects With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

Clinical trial2026-06-01Results posted · ClinicalTrials.gov

An Exploratory Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics (PK/PD) of Nemolizumab in Adult Participants With Chronic Pruritus of Unknown Origin (CPUO)

Clinical trial2026-06-01Results expected Q3 2026 · ClinicalTrials.gov

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Nemolizumab in Subjects With Chronic Kidney Disease With Associated Moderate to Severe Pruritus

Clinical trial2026-05-01Results posted · ClinicalTrials.gov

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Nemolizumab in Adult Patients With Systemic Sclerosis

Clinical trial2026-03-31Results expected Q2 2028 · ClinicalTrials.gov

An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis

Clinical trial2026-02-13Results posted · ClinicalTrials.gov

Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.

Clinical trial2026-02-10Results expected Q2 2027 · ClinicalTrials.gov

Approval: Nemluvio (EMA)

Regulatory2025-02-12EMA

Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis.

Research2023-10-01The New England journal of medicine

Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis.

Research2017-03-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Nemolizumab
Aliases & brands
Nemluvio
RxNorm CUI
2691310
ChEMBL ID
CHEMBL4297794
ATC codes
D11AH12
UNII
GN465U8B72
Primary mechanism
Interleukin-31 receptor subunit alpha inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interleukin-31 receptor subunit alpha
IL31RA · Q8NI17
INHIBITORInterleukin-31 receptor subunit alpha inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2025-02-12
Latest approval
2025-02-12
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2025-02-12Approval
Approval: Nemluvio (EMA)
Indication: 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… Show full indication

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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

22 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
22
registered trials across all phases
LATEST COMPLETION 2025
7
Active studies
5
Recruiting
11
Late-stage (III+)
14
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 22
Phase 11Phase 210Phase 2 / 31Phase 38Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Utilization of a Cutaneous Therapy In Situ Microdevice

Not yet recruitingPH IVUniversity of California, San Franciscon=102030

Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.

RecruitingPH IVThe Skin Center Dermatology Groupn=102027

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

Active, not recruitingPH IIIGalderma R&Dn=5002026

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis

Active, not recruitingPH IIIKey trialGalderma R&Dn=1,7002026

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Nemolizumab in Subjects With Chronic Kidney Disease With Associated Moderate to Severe Pruritus

CompletedPH II/IIIGalderma R&Dn=2582024

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (Aged 2 to 11 Years) With Moderate-to-Severe Atopic Dermatitis

CompletedPH IIGalderma R&Dn=1092025

An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis

CompletedPH IIMaruho Co., Ltd.n=62024

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Nemolizumab in Subjects With Chronic Kidney Disease With Associated Moderate to Severe Pruritus

CompletedPH II/IIIGalderma R&Dn=2582024

A Double-Blind, Placebo-Controlled, Randomized Study to Assess the Durability of Effect and Safety of Nemolizumab for 24 Weeks in Subjects With Prurigo Nodularis

CompletedPH IIIGalderma R&Dn=342023

A Randomized, Double-Blind, Placebo-Controlled Study to Assess Immunization Responses in Adult and Adolescent Subjects With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

CompletedPH IIGalderma R&Dn=2422023

An Open-label Drug-Drug Interaction Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Subjects With Moderate-to-Severe Atopic Dermatitis

CompletedPH IIGalderma R&Dn=172023

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20172023
Most influential

Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis.

The New England journal of medicine · 2017 · 375 cites

Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis.

The New England journal of medicine · 2023 · 111 cites
Recent papers

Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis.

The New England journal of medicine · 2023 · 111 cites

Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis.

The New England journal of medicine · 2017 · 375 cites
Major research themes3
Antibodies, Monoclonal, Humanized1Prurigo1Receptors, Interleukin1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine2
Leading researchers
  • Ahmad F1
  • Barbarot S1
  • Conrad C1
  • De Bruin-Weller MS1
  • Etoh T1
  • Fleischer A1
  • Furue M1
  • Galus R1
Leading institutions
free-text, unnormalised
  • From Johns Hopkins Itch Center1
  • Ludwig Maximilian University1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.