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Nemluvio

Also known as nemolizumab

TypeInjection StageApproved Latest updateUpdated recently. Jul 13, 2026Phase 2 study started

What stands out

  • Injection every 4 weeks
  • Blocks IL-31 receptor, part of the docking point for IL-31, a signal involved in skin immunity
Derived from US label · UniProt Q8NI17 · MedlinePlus: Nemolizumab-ilto injection ·
3 US eczema labels (Dupixent, Ebglyss, Adbry)
· This is a summary of public records for informational purposes only. It is not medical advice.

Results

Trial: NCT03985943
Clear or almost clear skinAfter 16 weeks
Initial Treatment Period (Baseline - Week 16 Predose): Placebo321 people
25 in 100
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg620 people
36 in 100
02040
+12
more people in 100 reached it on Nemluvio than on placebo.
The sponsor’s 97.5% confidence range is 5 to 18 more (out of 100).
Eczema score (EASI) at least 75% betterAfter 16 weeks
Initial Treatment Period (Baseline - Week 16 Predose): Placebo321 people
29 in 100
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg620 people
44 in 100
03060
+15
more people in 100 reached it on Nemluvio than on placebo.
The sponsor’s 97.5% confidence range is 8 to 22 more (out of 100).
NCT03985943 · Ages 12+ · Results posted Aug 2024 · This is a summary of trial data for informational purposes only. It is not medical advice.
Trial: NCT03985943
Itch score at least 4 points betterAfter 16 weeks
Initial Treatment Period (Baseline - Week 16 Predose): Placebo321 people
18 in 100
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg620 people
43 in 100
03060
+25
more people in 100 reached it on Nemluvio than on placebo.
The sponsor’s 97.5% confidence range is 18 to 32 more (out of 100).
NCT03985943 · Ages 12+ · Results posted Aug 2024 · This is a summary of trial data for informational purposes only. It is not medical advice.
What is IGA?
  • IGA stands for Investigator's Global Assessment.
  • IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of atopic dermatitis (AD) and the clinical response to treatment.As this trial registered it · NCT03985943 (the full definition is there)
What is EASI?
  • EASI stands for Eczema Area and Severity Index.
  • EASI-75 was defined as >=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected.As this trial registered it · NCT03985943 (the full definition is there)
What is the itch score?
  • NRS stands for Numeric Rating Scale.
  • The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available.As this trial registered it · NCT03985943 (the full definition is there)
Why this trial?

Of Nemluvio’s 7 trials with posted results, NCT03985943 is shown first: of the trials that compared the drug with placebo on a result this page charts, it had the most US sites (57). We rank those trials by whether they set out to measure skin clearing, whether they tested the drug on its own, their phase, whether they were randomised, whether they included adults, whether they ran in the US, how many doses they tested, how many US sites they had, their size, and then how recently they finished.

All 7 Nemluvio trials
PostedTrialPhaseAgesPeople
May 2026NCT04921345Phase 22–12109
Jun 2025NCT04365387Phase 212–54242
Dec 2024NCT04562116Phase 218+17
Aug 2024NCT03985943 Shown abovePhase 312+941
Aug 2024NCT03989349Phase 312+787
Apr 2023NCT03921411Phase 212–1720
Nov 2021NCT01986933Phase 218–65264

Side effects

Atopic Dermatitis (incidence ≥1%): headache (including migraine), arthralgia, urticaria, and myalgia.

FDA label dated Jun 26, 2025

History

Earliest recorded event: Apr 1, 2015. This timeline shows events collected by Eczema Radar and may not include the treatment’s full history. Study details reflect the latest registry record available here.

  • Aug 13, 2026Phase 3 trial postedRandomized, Double-blind, Placebo-controlled Study of Nemolizumab in Chinese Subjects With Moderate-to-severe Atopic Dermatitis ClinicalTrials.gov NCT07762833
  • Jul 13, 2026Phase 2 trial startedPharmacokinetics, Safety and Efficacy of Nemolizumab in Participants Aged 6 to 23 Months With Moderate-to Severe Atopic Dermatitis ClinicalTrials.gov NCT07660835
  • May 26, 2026Phase 2 results postedPharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT04921345
  • Jun 5, 2025Phase 2 results postedA Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab ClinicalTrials.gov NCT04365387
  • Apr 28, 2025Phase 2 trial completedPharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT04921345
  • Dec 13, 2024FDA approval for eczema Galderma announcement
  • Dec 5, 2024Phase 2 results posted · Basic-science trialA Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Participants With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT04562116
  • Aug 14, 2024Phase 3 results postedEfficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT03989349
  • Aug 14, 2024Phase 3 results postedEfficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT03985943
  • Aug 12, 2024First FDA approvalFirst FDA approval of the drug. FDA approval letter
  • Jul 7, 2023Phase 2 trial completedA Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab ClinicalTrials.gov NCT04365387
  • Jun 7, 2023Phase 2 trial completed · Basic-science trialA Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Participants With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT04562116
  • Apr 21, 2023Phase 2 results postedA Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD) ClinicalTrials.gov NCT03921411
  • Sep 26, 2022Phase 3 trial completedEfficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT03989349
  • Aug 11, 2022Phase 3 trial completedEfficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT03985943
  • Feb 23, 2022Phase 3 main data collectedEfficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT03989349
  • Dec 29, 2021Phase 3 main data collectedEfficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT03985943
  • Dec 8, 2021Phase 2 trial started · Basic-science trialA Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Participants With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT04562116
  • Nov 22, 2021Phase 2 results postedA Phase 2 Study of CIM331 for Atopic Dermatitis Patients ClinicalTrials.gov NCT01986933
  • Sep 27, 2021Phase 3 trial posted · Withdrawn before enrollingEfficacy 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 Why it stopped: The study data will not be utilized in the IND and is only being conducted in EU. ClinicalTrials.gov NCT05056779
  • Jun 24, 2021Phase 2 trial startedPharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT04921345
  • Aug 19, 2020Phase 2 trial completedA Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD) ClinicalTrials.gov NCT03921411
  • Mar 5, 2020Phase 2 trial startedA Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab ClinicalTrials.gov NCT04365387
  • Dec 30, 2019Phase 3 trial startedLong-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis ClinicalTrials.gov NCT03989206
  • Jun 30, 2019Phase 3 trial startedEfficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT03989349
  • Jun 27, 2019Phase 3 trial startedEfficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis ClinicalTrials.gov NCT03985943
  • Apr 9, 2019Phase 2 trial startedA Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD) ClinicalTrials.gov NCT03921411
  • Jun 1, 2016Phase 2 trial completedA Phase 2 Study of CIM331 for Atopic Dermatitis Patients ClinicalTrials.gov NCT01986933
  • Apr 1, 2015Phase 2 main data collectedA Phase 2 Study of CIM331 for Atopic Dermatitis Patients ClinicalTrials.gov NCT01986933

Sources

From the FDA
Trials
For patients