NEMLUVIO (nemolizumab-ilto)
NEMLUVIO is indicated for the treatment of Prurigo Nodularis; Atopic Dermatitis.
How NEMLUVIO Works
Nemolizumab-ilto is a humanized IgG2 monoclonal antibody that inhibits IL-31 signaling by binding selectively to the interleukin-31 receptor alpha (IL-31 RA). IL-31 is a naturally occurring cytokine involved in pruritus, inflammation, epidermal dysregulation, and fibrosis. By blocking this receptor, the drug inhibits IL-31-induced responses, including the release of proinflammatory cytokines and chemokines.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-08-12
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NEMLUVIO Approval History
What NEMLUVIO Treats
2 indicationsNEMLUVIO is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prurigo Nodularis
- Atopic Dermatitis
NEMLUVIO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in NEMLUVIO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NEMLUVIO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to NEMLUVIO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
19 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05075408 NIKAIA 1 results posted | RD.06.SPR.204358 2021-004766-35 | Ph 2, Ph 3 | completed | To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus |
| NCT07074977 CPUO | SPR207913 | Ph 2 | recruiting | Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO) |
| NCT07047690 | SPR207796 | Ph 2 | recruiting | A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis |
| NCT05214794 results posted | M525101-21 | Ph 2 | completed | An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis |
| NCT07396168 | NemoLPP | Ph 4 | recruiting | Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study. |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT04204616 | RD.06.SPR.202699 2019-004294-13 | Ph 3 | active not recruiting | A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) |
| NCT04921345 | RD.06.SPR.118126 | Ph 2 | completed | Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis |
| NCT04365387 results posted | RD.06.SPR.118380 | Ph 2 | completed | A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab |
| NCT05405985 results posted | RD.06.SPR.201590 | Ph 1 | completed | Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe |
| NCT04562116 results posted | RD.06.SPR.201593 | Ph 2 | completed | A Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Participants With Moderate-to-Severe Atopic Dermatitis |
| NCT03989206 | RD.06.SPR.118163 | Ph 3 | active not recruiting | Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis |
| NCT05052983 results posted | RD.06.SPR.203890 2021-003928-32 | Ph 3 | completed | A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis |
| NCT03985943 results posted | RD.06.SPR.118161 | Ph 3 | completed | Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis |
| NCT03989349 results posted | RD.06.SPR.118169 | Ph 3 | completed | Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis |
| NCT04501679 results posted | RD.06.SPR.203065 2019-004789-17 | Ph 3 | completed | A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) |
| NCT05056779 | RD.06.SPR.201591 2021-002166-40 | Ph 3 | withdrawn | 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 |
| NCT03921411 results posted | RD.06.SPR.116912 | Ph 2 | completed | A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD) |
| NCT03100344 results posted | RD.03.SPR.114322 | Ph 2 | completed | Dose-ranging Study of Nemolizumab in Atopic Dermatitis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NEMLUVIO FDA Label Details
Indications & Usage
FDA Label (PDF)NEMLUVIO is indicated for the treatment of Prurigo Nodularis; Atopic Dermatitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment