Quick answers
- What is Nemolizumab-ilto used for?
- The FDA-approved label (Nemluvio, Galderma Laboratories, L.P., June 26, 2025) says: “NEMLUVIO is an interleukin-31 receptor antagonist indicated for: Prurigo Nodularis The treatment of adults with prurigo nodularis. Atopic Dermatitis The treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nemolizumab-ilto have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nemolizumab-ilto?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nemolizumab-ilto been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Nemolizumab-ilto?
- 1 company lists prescription products of Nemolizumab-ilto in the FDA NDC Directory, including Galderma Laboratories, L.P..
What Nemolizumab-ilto is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
NEMLUVIO is an interleukin-31 receptor antagonist indicated for: Prurigo Nodularis The treatment of adults with prurigo nodularis. Atopic Dermatitis The treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription …
— FDA label: Nemluvio, Galderma Laboratories, L.P., effective June 26, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Nemluvio |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Galderma Laboratories, L.P.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761390 NEMLUVIO | Galderma Labs LP | August 12, 2024 | 2, latest June 26, 2025 2025: Labeling · 2025: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2691325, 2691328 |
|---|---|
| SPL set ID of the quoted label | e9229ef1-ac60-4c24-afb6-009d3c781687 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761390 |
| Active ingredients (FDA) | NEMOLIZUMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nemluvio, Galderma Laboratories, L.P., effective June 26, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →